Clinical efficacy of Rajanyadi Choornam in Allergic Respiratory Disease in...

[Full title: Clinical efficacy of Rajanyadi Choornam in Allergic Respiratory Disease in Children]

[Find the meaning and references behind the names: Meera, Madhu, Anilkumar]

ORIGINAL ARTICLE March 2023 Journal of Ayurveda and Integrated Medical Sciences | March 2023 | Vol. 8 | Issue 3 1 Clinical efficacy of Rajanyadi Choornam in Allergic Respiratory Disease in Children Meera S Panicker 1 , Anilkumar M.V. 2 1 Post Graduate Scholar, Department of Kaumarabhritya, Government Ayurveda College, Thiruvananthapuram, Kerala, India. 2 Professor & Head, Department of Kaumarabhritya, Government Ayurveda College, Thiruvananthapuram, Kerala, India. I NTRODUCTION Allergic Respiratory Disease is a frequent atopic condition, manifesting through allergic rhino conjunctivitis and asthma [1] An allergic condition which is a hypersensitivity disorder of the immune system, is one of the major causes of recurrent respiratory diseases among the pediatric population Address for correspondence: Dr. Meera S Panicker Post Graduate Scholar, Department of Kaumarabhritya, Government Ayurveda College, Thiruvananthapuram, Kerala, India. E-mail: meerasuma 90@gmail.com Submission Date: 13/01/2022 Accepted Date: 21/02/2023 Access this article online Quick Response Code Website: www.jaims.in DOI: 10.21760/jaims.8.3.1 Various air borne allergens can induce a variety of upper respiratory symptoms with a wide spectrum of severity, which includes nasal congestion, watery nasal discharge, paroxysmal sneezing, chest congestion, cough, sore throat etc. Allergic respiratory disorders are characterized by an increase of serum IgE levels. A serum total IgE higher than 100 IU/ml before the age of six years have a higher risk of being atopic [2] Need and significance of study Allergic respiratory disease affects, up to 40% of the population worldwide and with a significant impact over the quality of life [1] Allergic diseases in children have increased significantly in recent years and affect up to 35% of children. Various studies have quoted the prevalence of the same as 20% in children and 30% in adults [3] The onset of allergic responses appears to be highest in the school going children, usually before 5 years of age Allergy is confirmed in 35 to 38% of upper respiratory tract infections in children and pose an A B S T R A C T Allergic Respiratory Disease (ARD) is a frequent atopic condition manifesting through allergic rhino conjunctivitis and asthma, affecting up to 40% of the population world-wide. Though not viewed as a life-threatening condition, it is also recognized to impose a significant burden to the quality of life of sufferers and their caretakers. It is apparent from epidemiology studies that the Allergic Respiratory Disease in younger children below the age of 5 years is a relatively common problem. Many conventional managements provide only symptomatic relief resulting in recurrence of the disease. At the same time Ayurveda, aims at the elimination of the disease from its root cause rather than providing only a symptomatic relief that may cause recurrence of the condition. Rajanyadi Choornam is one such herbal formulation mentioned in the classics which would enhance the status of digestive fire ( Grahani Deepanam Sreshtam ) and helps in proper channelization of Vata ( Vataanulomana ), providing considerable relief to symptoms. A total of 32 children of age group 2-5 years satisfying the inclusion criteria were included in the study. The participants were given Rajanyadi Choornam in a dose of 2.5 gm twice daily with 5 ml of Madhu and Ghritam taken in unequal quantities. The severity of clinical symptoms and blood parameters (serum IgE, AEC) were assessed after 45 days of intervention. For clinical evaluation data regarding the severity of symptoms were collected and laboratory investigations like Serum Total IgE, AEC were done in the children both before and after drug intervention. The results were analysed statistically and reduction of symptoms was statistically significant. Key words: Allergic Respiratory Disease, AEC, Rajanyadi Choornam, Serum IgE

[Find the meaning and references behind the names: Rajani, Anna]

Meera S Panicker et al. Clinical efficacy of Rajanyadi Choornam in Allergic Respiratory Disease ISSN: 2456-3110 ORIGINAL ARTICLE March 2023 Journal of Ayurveda and Integrated Medical Sciences | March 2023 | Vol. 8 | Issue 3 2 important risk factor for the same [2] These allergic disorders are often under diagnosed and under treated, creating considerable burden on children and families and is responsible for approximately 1% of all disability adjusted life years lost worldwide. Complications has also been reported to increase health care cost of the affected child [3] Therefore, even though, mostly a nonlife threatening conditions, they can impair the person’s ability to function. The probability to develop allergies to various allergens is largely genetically determined. The risk is increased from 25% in general population to about 75% when both the parents are atopic. Although there is a genetic predisposition, it is the exposure to environmental allergens, irritants and infections that will determine the sensitization to different allergens In Ayurvedic science, even though Allergic Respiratory Disease presents with a vivid symptomatology like rhinitis ( Pratisyaya ), cough ( Kasa) , sneezing ( Kshwathu ), dyspnea ( Swasa) etc. the root cause of these symptoms remains the same, as one acts as the precipitating factor for other. Our science aims at the elimination of a disease from its root cause rather than providing only a symptomatic relief that may cause recurrence of the condition. In children the Pranavaha Srotas easily gets affected as their digestive fire ( Agni) is unstable due to non-acclimatization with different states of food (Aharasankaratwat ) [4] This digestive fire ( Agni ) is closely related to Pitta Dosha and thus resulting in the simultaneous vitiation of the same. Moreover, the site of Pranavaha Srotas is at Kapha Sthana and children are more in Kapha predominant stage. So mostly Kaphaja disease are encountered with Pranavaha Srotas in children. Vitiation of Pranavaha Srotas sequentially results in the vitiation of Anna and Udakavaha Srotas . Thus, the vitiation of Kapha and Pitta Dosha along with vitiation of Prana, Anna, Udakavaha Srotas gives rise to many symptoms pertaining to upper respiratory tract. So, managing at the root level i.e., correction of the deranged digestive fire ( Agni ) and maintaining its equilibrium prevents the subsequent Dushti of Doshas and Srotas . This helps in further recurrence of the condition. Rajanyadi Choornam is one such herbal formulation mentioned in the classics which would enhance the status of digestive fire ( Grahani Deepanam Sreshtam ), thereby alleviating Pitta Dosha and helps in proper channelization of Vata ( Vataanulomana ) [5] This formulation helps in establishing the enriched status of the different body tissues and imparts strength. It ultimately helps in preventing the recurrence of the condition in the child. A IM AND O BJECTIVES The study intends to find the effect of Rajanyadi Choornam in improving the recurrent respiratory allergic symptoms in children between age group of 2 to 5 years. The aim was to reduce the severity and duration of exacerbations to the minimum providing quality life to these children. M ATERIALS AND M ETHODS Materials used in the study are 1 Trial Drug 2 Study tools Trial drug The drug Rajanyadi Choornam mentioned in Ashtanga Hrudaya Utharasthana Balamaya Pratishedha and exclusively used in the management general paediatric ailments. Collection of materials Raw drugs were collected from a reputed raw drug shop for genuine raw drugs in Thiruvananthapuram district. The authenticities of raw drugs were tested in the pharmacology department of the Government Ayurveda College Thiruvananthapuram. Drugs were washed, cleaned, and dried well. Preparation of medicine The medicine was prepared in the pharmacy of Govt. Ayurveda College, Thiruvananthapuram as per classical reference. Ingredients 1 Rajani / Haridra - Curcuma longa Linn. 2 Devadaru - Cedrus deodara

Meera S Panicker et al. Clinical efficacy of Rajanyadi Choornam in Allergic Respiratory Disease ISSN: 2456-3110 ORIGINAL ARTICLE March 2023 Journal of Ayurveda and Integrated Medical Sciences | March 2023 | Vol. 8 | Issue 3 3 3 Sarala - Pinus roxburghii Sarg 4 Sreyasi - Piper chaba Linn. 5 Brhati - Solanum indicum Linn 6 Kantakari - Solanum xanthocarpum Schrad 7 Prsniparni - Uraria picta Desv 8 Satahwa - Anethum sowa Kurz Method of preparation of Rajanyadi Choornam The medicine was prepared as per the classical reference. The drugs mentioned in the formulation are taken in equal quantities. They were washed, cleaned, dried, powdered and mixed well. The prepared Choornam were stored in an airtight container. The raw drugs were purchased from GMP certified authorized raw drugs shop. Study tools ▪ Subjective parameters: severity of 8 clinical symptoms sneezing, running nose, nasal congestion, cough, sore throat, scratchy throat, hoarseness, itching of eyes. ▪ Objective parameters: Serum IgE, AEC. Table 1: Symptom Severity Grade Symptom None Grade 0 Mild Grade 1 Moderate Grade 2 Severe Grade 3 Sneezing No sneezes Few short episodes of sneezing Occasional sneezes Frequent sneezes Runny Nose No runny nose Had to wipe (or blow) nose rarely Had to wipe (or blow) occasional ly Had to wipe (or blow) frequently Nasal congestio n No congestio n Breathing through slightly Breathing through nose noisy, has nasal speech, breathes through Breathes through moth almost all the times because of nasal congestio mouth sometime s n, nasal speech Cough No cough Few short episodes of coughing Occasional cough / rare episodes of prolonged coughing Frequent cough/at least occasional episodes of prolonged coughing Sore throat No sore throat Mild pain with swallowin g Moderate pain with swallowin g Very painful to swallow Scratchy throat No throat pain Infrequen t complaint of pain in mouth or throat, discomfor t mild Occasional complaint of pain in mouth or throat, moderate discomfort Frequent complains of pain in mouth or throat or severe discomfor t Hoarsene ss No change in voice Speech is slightly hoarse or husky Speech is very hoarse or husky Cannot speak above a whisper because of hoarsenes s Itching of eyes No itching Steady symptom s but easily tolerable Symptoms hard to tolerate, may interfere with sleep or activities of child Symptom s are so bad; child cannot function all the time. Table 2: Severity of clinical symptoms SN Symptoms Before Treatment After Treatment 1. Sneezing 2. Runny nose

Meera S Panicker et al. Clinical efficacy of Rajanyadi Choornam in Allergic Respiratory Disease ISSN: 2456-3110 ORIGINAL ARTICLE March 2023 Journal of Ayurveda and Integrated Medical Sciences | March 2023 | Vol. 8 | Issue 3 4 3. Nasal congestion 4. Cough 5. Sore throat 6. Scratchy throat 7. Hoarseness 8. Itching of eyes Table 3: Blood Investigations Blood Parameters Before Treatment After Treatment Serum IgE Absolute Eosinophil Count M ETHODOLOGY Study design: Quasi experimental design, pre and posttest study, single group Study setting: Govt. Ayurveda College Hospital for Women and Children, Poojappura, Thiruvanathapuram. Study duration: 45 days Study period: 18 months Study population: Source population is children of both the sex of the age group of 2 to 5 years suffering from Allergic Respiratory Disease, attending the outpatient wing of Dept of Kaumarabhritya, Govt. Ayurveda College Hospital for Women & Children, Poojappura, Thiruvananthapuram. Inclusion criteria Children showing the clinical symptoms of allergic respiratory disease with serum total IgE 60 IU/ml - 1000 IU/ml. Exclusion criteria ▪ Children with acute respiratory tract infection. ▪ Diagnosed case of bronchial asthma. ▪ Diagnosed case of any chronic systemic illness. ▪ Children on regular oral corticosteroids, decongestant, antihistamines, inhalers. ▪ Children who are known case of Deviated Nasal Septum, nasal polyp, adenoiditis. Sample size: 32 patients were included in the study. Sampling technique All the consecutive cases, satisfying inclusion criteria coming to the OPD of Kaumarabhritya department were recruited to the study until the sample size is attained. Methods of Data Collection The qualitative data related to the clinical condition was collected as per the case proforma. The information included the were the data related to the patient such as name, age, domicile etc followed by chief complaints with history of present illness to reveal the gravity of the problem, past history to know any predisposing factors. Similarly, personal history to find out the diet, appetite, bowel and bladder habits, family history to know any relevant history of similar complaints in the family. Obstetric history and immunization history were also taken. General and systemic examination was also taken to know the severity of the condition or any associated diseases. For clinical evaluation, data regarding the severity of 8 symptoms - sneezing, running nose, nasal congestion, cough, sore throat, scratchy throat, hoarseness, itching of eyes was collected. Laboratory investigations like Serum Total IgE, AEC are also done in the children. Procedure Children with clinical features of Allergic Respiratory Disease was selected from the OPD of department of Kaumarabhritya as per the inclusion criteria. The child was assessed using the case proforma. Blood investigations were done to assess the objective parameters like serum IgE, Absolute Eosinophil Count. Rajanyadi Choornam was prepared as per the classical reference and properly packed. The participants were given Rajanyadi Choornam in a dose of 2.5 gm twice daily with 5 ml of Madhu and Ghritam taken in unequal

[Find the meaning and references behind the names: Main]

Meera S Panicker et al. Clinical efficacy of Rajanyadi Choornam in Allergic Respiratory Disease ISSN: 2456-3110 ORIGINAL ARTICLE March 2023 Journal of Ayurveda and Integrated Medical Sciences | March 2023 | Vol. 8 | Issue 3 5 quantities continuously for a period 45 days. Mode of administration was well explained to the parents. The patient was advised to maximum avoidance to various triggering factors such as dusts, mites, pollen etc. No strict diet restrictions were advised. The severity of clinical symptoms and blood parameters (serum IgE, AEC) were assessed after 45 days of intervention. Assessment Criteria ▪ Improvement in the clinical symptoms of Allergic Respiratory Disease ▪ Blood parameters (IgE, AEC). Statistical Analysis Quantitative Variables were expressed as mean, SD, median and inter quartile range and qualitative variables were expressed as proportion. Paired comparison of qualitative variable was analysed by Wilcoxon signed rank test and quantitative variables were analysed by paired-t test. Data analysis was performed using SPSS ver 17.0. O BSERVATION AND R ESULTS Data related to different quantitative and qualitative parameters were collected and calculated the mean and standard deviation before and after the treatment. The significance of effectiveness of the treatment on qualitative and quantitative parameters was statistically analysed by Wilcoxon Signed Rank test and Paired t test respectively. A calculated p value <0.05 was considered to be statistically significant. 1. Effectiveness of treatment on clinical assessment Clinical assessment of ARD was done by grading the clinical features according to severity of attacks. They were graded as no symptom, mild, moderate and severe symptom. Since they are qualitative parameters, ranking with suitable score was given and statistical analysis was done using Wilcoxon Signed Rank test. The eight main features which are frequently seen in ARD were considered for the evaluation before and after the treatment Table 4: Effectiveness of treatment on Sneezing Sneezing BT AT n % n % No sneezing 0 0 4 12.5 Mild 5 15.6 20 62.5 Moderate 16 50 8 25 Severe 11 34.4 0 0 Total 32 100 32 100 Z p Wilcoxon Signed Rank test 5.203 <0.001 Out of 32 participants, 50% of the children had moderate sneezing followed by severe sneezing in 34.4%. Mild sneezing was noted in 15.6% of children. After treatment around 12% of participants completely relieved from the symptom and majority (62%) had only mild sneezing. 25% of the group had moderate sneezing and none of the participants had severe sneezing. Since the p value <0.001, it is statistically highly significant. Figure 1: Comparison of sneezing before and after treatment Table 5: Effectiveness of treatment Running Nose Running Nose BT AT n % N % No runny nose 1 3.1 4 12.5 0% 20% 40% 60% 80% 100% BT AT Sneezing Severe Moderate Mild No sneezing

Meera S Panicker et al. Clinical efficacy of Rajanyadi Choornam in Allergic Respiratory Disease ISSN: 2456-3110 ORIGINAL ARTICLE March 2023 Journal of Ayurveda and Integrated Medical Sciences | March 2023 | Vol. 8 | Issue 3 6 Mild 2 6.3 16 50 Moderate 16 50 12 37.5 Severe 13 40.6 0 0 Total 32 100 32 100 Z p Wilcoxon Signed Rank test 5.416 <0.001 Half of the participants had moderate running nose (50%) and around 40% had severe running nose before the treatment. After the treatment it was noted that percentage of participants with moderate running nose reduced to 37% and none of them had severe running nose. Half of the participants had only mild running nose (50%) after treatment. Since the p value is <0.001, it is statistically highly significant. Figure 2: Comparison of Running nose before and after treatment Table 6: Effectiveness of treatment on Nasal congestion Nasal Congestion BT AT n % n % No Nasal Congestion 1 3.1 5 15.6 Mild 5 15.6 20 62.5 Moderate 16 50 7 21.9 Severe 10 31.3 0 0 Total 32 100 32 100 Z P Wilcoxon Signed Rank test 5.26 <0.001 50% of the children had moderate nasal congestion before treatment which changed to 21.9% after treatment. Severe nasal congestion was found in 31.3% of patients but after treatment none of them had severe nasal congestion. Around 15% got completely cured from the symptom. It was found to be statistically significant since the p value was<0.001. Since the p value is <0.001, it is statistically highly significant. Figure 3: Comparison of nasal congestion before and after treatment Table 7: Effectiveness of treatment on Cough Cough BT AT n % n % No Cough 3 9.4 6 18.8 Mild 10 31.3 19 59.4 Moderate 14 43.8 7 21.9 Severe 5 15.6 0 0 Total 32 100 32 100 Z p Wilcoxon Signed Rank test 4.264 <0.001 0% 20% 40% 60% 80% 100% BT AT Running Nose Severe Moderate 0% 20% 40% 60% 80% 100% BT AT Nasal Congestion Severe Moderate Mild

Meera S Panicker et al. Clinical efficacy of Rajanyadi Choornam in Allergic Respiratory Disease ISSN: 2456-3110 ORIGINAL ARTICLE March 2023 Journal of Ayurveda and Integrated Medical Sciences | March 2023 | Vol. 8 | Issue 3 7 Moderate cough was present in nearly half of the children (43.8%) and mild cough in 31.3% of children before treatment. After treatment moderate cough was noted in 21.9% participants. None of them presented with severe cough after treatment and majority of children had only mild cough (59.4%). 18.8% of children had no episodes of cough after treatment which was only 9% before treatment. Figure 4: Comparison of cough before and after treatment Table 8: Effectiveness of treatment on Sore throat Sore Throat BT AT n % N % No Sore throat 20 62.5 31 96.9 Mild 11 34.4 1 3.1 Moderate 1 3.1 0 0 Severe 0 0 0 0 Total 32 100 32 100 Z p Wilcoxon Signed Rank test 3.464 <0.001 Only mild sore throat was present in 34.4% of the children and more than half of them had no sore throat (62.5%) before treatment. After treatment it was found that those with mild sore throat considerably reduced to 3.1% and 96.9% had no symptom. Since the p value is <0.001, it is statistically highly significant. Figure 5: Comparison of sore throat before and after treatment Table 9: Effectiveness of treatment on Scratchy throat. Scratchy Throat BT AT n % n % No Scratchy Throat 19 59.4 31 96.9 Mild 12 37.5 1 3.1 Moderate 1 3.1 0 0 Severe 0 0 0 0 Total 32 100 32 100 Z p Wilcoxon Signed Rank test 3.606 0.001 59.4% of the children had no complaints of scratchy throat before treatment which increased to 96.9% after treatment. After treatment 3.1% had only mild scratchy throat. Since the p value is <0.05, it is statistically significant. Figure 6: Comparison of Scratchy throat before and after treatment 0% 20% 40% 60% 80% 100% BT AT Cough Severe Moderate Mild No Cough 0% 20% 40% 60% 80% 100% BT AT Sore Throat Moderate Mild No Sore throat 0% 20% 40% 60% 80% 100% BT AT Scratchy Throat Moderate Mild No Scratchy Throat

Meera S Panicker et al. Clinical efficacy of Rajanyadi Choornam in Allergic Respiratory Disease ISSN: 2456-3110 ORIGINAL ARTICLE March 2023 Journal of Ayurveda and Integrated Medical Sciences | March 2023 | Vol. 8 | Issue 3 8 Table 10: Effectiveness of treatment on Hoarseness of voice Hoarseness BT AT n % n % No change in voice 31 96.9 32 100 Mild change 1 3.1 0 0 Total 32 100 32 100 Z p Wilcoxon Signed Rank test 1 0.317 Majority of the participants showed no change in voice (96.9%) and only 3.1% had mild change in voice. After treatment none of them had the complaints of hoarseness of voice. Since the p value is greater than 0.05, it suggests no significant effect of study drug in curing hoarseness of voice. Figure 7: Comparison of Hoarseness of voice before and after treatment Table 11: Effectiveness of treatment on Itching of eyes. Itching of eyes BT AT n % n % No itching 15 46.9 24 75 Mild 16 50 8 25 Moderate 1 3.1 0 0 Total 32 100 32 100 Z p Wilcoxon Signed Rank test 3.162 0.002 Half of the children presented with complaints of mild itching of eyes (50%) and moderate itching was present in 3.1% of participants. Around 46% had no complaints before the treatment. After treatment it was noted that children with mild itching of eyes reduced to 25%. 75% of children got completely cured with the symptom. Since the p value is <0.05 it is said to be statistically significant. Figure 8: Comparison of Itching of eyes before and after treatment. Table 12: Effectiveness of treatment on Symptom severity total score. N Total score Paired difference Paired t test Mean SD Mean SD T P BT 3 2 9.47 2.64 4.69 1.91 13.89 6 <0.00 1 A T 3 2 4.78 1.77 The average symptom severity total score before treatment was 9.47±2.64 which after treatment changed to 4.78±1.77. Comparison between before and after treatment showed a significant reduction (p<0.001) suggestive of effectiveness of the study drug in reducing the symptoms. 95% 96% 97% 98% 99% 100% BT AT Hoarseness Mild change No change in voice 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% BT AT Itching of eyes Moderate Mild No itching

Meera S Panicker et al. Clinical efficacy of Rajanyadi Choornam in Allergic Respiratory Disease ISSN: 2456-3110 ORIGINAL ARTICLE March 2023 Journal of Ayurveda and Integrated Medical Sciences | March 2023 | Vol. 8 | Issue 3 9 Figure 9: Comparison of Symptom Severity Total Score before and after treatment BT AT 0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 S co re Symptom Severity Total Score BT AT 0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 S c o re Symptom Severity Total Score 2. Effectiveness of treatment on Haematological values Table 13: Effectiveness of treatment on Serum IgE N Serum IgE Paired difference Paired t test Mean SD Mean SD T p B T 3 2 683.4 6 261.3 0 119.38 86.9 9 7.76 4 <0.00 1 A T 3 2 564.0 8 215.3 9 The average serum IgE concentration before treatment was 683.46±261.30 which after treatment changed to 564.08±215.39. Comparison between before and after treatment showed a significant reduction (p<0.001) suggestive of effectiveness of the study drug in reducing the serum IgE levels. Figure 10: Comparison of Serum IgE levels before and after treatment BT AT 0 100 200 300 400 500 600 700 800 900 1000 1100 Ig E ( U I/m l) Serum IgE Table 14: Effectiveness of treatment on Absolute Eosinophil Count (AEC) N AEC Paired difference Paired t test Mean SD Mean SD t p B T 3 2 628.1 3 261.9 7 122.84 96.9 6 7.16 7 <0.00 1 A T 3 2 505.2 8 204.4 9 The average AEC concentration before treatment was 628.13±261.97 which after treatment changed to 505.28±204.49. Comparison between before and after treatment showed a significant reduction (p<0.001) suggestive of effectiveness of the study drug in reducing the AEC levels. Figure 11: Comparison of AEC levels before and after treatment. BT AT 0 100 200 300 400 500 600 700 800 900 1000 1100 A E C AEC

[Find the meaning and references behind the names: Veer, Guna, Karma, Kamala, Rasa]

Meera S Panicker et al. Clinical efficacy of Rajanyadi Choornam in Allergic Respiratory Disease ISSN: 2456-3110 ORIGINAL ARTICLE March 2023 Journal of Ayurveda and Integrated Medical Sciences | March 2023 | Vol. 8 | Issue 3 10 DISCUSSION Discussion on the study drug The study drug “ Rajanyadi Choornam ” is a simple formulation mentioned in Balaroga Adhikara in Ashtanga Hrudaya Uttarasthana . It is a polyherbal ayurvedic classical formulation used in Agnimāndya (digestive impairment), Atisāra (diarrhea), Jvara (fever), Kasa ( cough ), Kāmāla (jaundice), Pāṇḍ u (anemia) and Śvāsa (asthma) [5] Clinical experiences of many professionals have shown that the formulation is effective in managing respiratory allergies and recurrent infections by augmenting the immunity of the children. The drugs in the formulation have Deepana and Pachana properties which control the initial Āma formation which is very important in preventing the disease and this property is even mentioned in the indications of the formulation as Grahani Deepanam Sreshtam . The Katu Vipaka and Ushna Veerya of majority of drugs in the formulation eliminates the vitiated Kapha Doshas from the system clearing the obstruction in the channels. This ultimately helps in proper channelization of Vata . Apart from this, this classical preparation also offers a Tridoshahara action (pacifies Tridoshas ). Hence this formulation stabilise the status of Agni (digestive fire) thereby clearing the vitiation of Kapha and Pitta Doshas in Amasaya , remove the Utklishta Kapha from air pathways, helps in proper channelization of Vata ( Vataanulomana ) and most importantly, it acts over the respiratory system to strengthen and revitalize the system and make it immune and less susceptible to future attacks. The pharmacological studies on the drugs in the formulation revealed all of them has an antiinflammatory and anti-microbial action helping in recurrent respiratory infection. Haridra/Rajani is a well-known herb to the world for its therapeutic exhibits in terms of immune boosting, antihistamine, anti-inflammatory and antioxidant properties. Various studies have shown that hydroxy groups of curcumin play a significant role in exerting both the antioxidative and anti-allergic activities [6] Himachalol is one of the important chemical constituents in Devadaru has anti-allergic property. The volatile oils of Cedrus known to inhibit type ш hypersensitivity reaction and have immune-modulatory action [7] The spasmolytic and antioxidant action of Sarala helps in treating diseases of the eyes, ears, throat, blood and skin, bronchitis, inflammations, and itching. The alcoholic extract of the same has demonstrated significant anti-asthmatic activities in the tested models [8] Chavya belonging to the Panchakola group acts as an excellent digestive and appetizer along with its immune-modulatory, anti-tussive, expectorant properties. The drug also showed promising mast cell stabilizing activity reducing allergic symptoms [9] Brhati and Kantakari belongs to Laghu Panchamula group and has excellent action on inflammatory conditions. Both the drugs act effectively on respiratory conditions and has significant inhibition of all asthmatic reactions [10] Apigenin obtained from the extract of Solanum xanthocarpum ( Kantakari ) is having anti-allergic effects. Administration of apigenin before the last airway OVA challenge resulted in significant inhibition of all asthmatic reactions [11] Prisniparni has a significant role in managing upper respiratory conditions by virtue of its Vata Kaphahara property. Satahwa is also known for its digestive and carminative action and the pharmacological studies showed that the drug induced antimicrobial, anti-inflammatory, analgesic, antisecretory effects, smooth muscle relaxant effect and many other effects [12] Most of the drugs in the formulation possess antihistaminic action and hence possess potential role in the treatment of asthma and allergic disorders. They also have antioxidant and immune-modulatory actions which is significant in boosting the immune system, thereby preventing recurrent attacks. Ayurveda pharmaco-dynamic properties of ingredients of Rajanyadi Choornam are tabulated below. Table 15: Ayurveda pharmaco-dynamic properties of ingredients of Rajanyadi Choornam. Name of ingredie nt Rasa Guna Veer ya Vipak a Karma Rajani (Curcum Katu, Tiktha Rooks ha Ushn a Katu Krimighna, Vishaghna, Pramehanas

[Find the meaning and references behind the names: Sara, Honey]

Meera S Panicker et al. Clinical efficacy of Rajanyadi Choornam in Allergic Respiratory Disease ISSN: 2456-3110 ORIGINAL ARTICLE March 2023 Journal of Ayurveda and Integrated Medical Sciences | March 2023 | Vol. 8 | Issue 3 11 a longa Linn .) aka, Kaphapittan ut Devadar u (Cedrus deodara Roxb .) Tiktha Laghu, Snigdh a Ushn a Katu Vatahara, Kaphahara Sarala (Pinus roxburg hii Sargent ) Katu, Tiktha, Kashay a Laghu, Snigdh a, Teeksh na Ushn a Katu Dipana, Kaphahara, Raksoghna, Vatahara, Visaghna Sreyasi (Piper chaba) Katu Laghu, Ruksh a Ushn a Katu Kapha Vatahara, Pittavardha na, Deepaniya Brhati (Solanu m indicum Linn .) Katu, Tiktha Laghu, Ruksh a Ushn a Katu Kaphavatah ara , Amadoshah ara Kantaka ri (Solanu m suratten se Burm ) Katu, Tiktha Laghu, Ruksh a, Teeksh na Ushn a Katu Deepana, Pachana, Amadoshah ara, Kapha Vatahara, Pitha Vardhaka Prishnip arni (Uraria picta) Madhu ra, Tiktha, Amla, Katu Laghu, Sara Ushn a Madh ura Balances Vata and Kapha, Deepaniya Satahwa (Anethu m sowa Roxb .) Katu, Tiktha Laghu, Teeksh na Ushn a Katu Balances Vata , Kapha, Deepaniya Another important feature of the formulation is the adjuvant mentioned for its administration. Combination of Madhu and Grta is included under the group of incompatible foods ( Virudha Ahara ) and Acharya Charaka has quoted that heated honey and honey mixed with equal ghee produce deleterious effects in the body and may cause death also. But in unequal proportions they can be taken. Madhu has a scraping effect removing the morbid Kapha Dosha from the channels and also pacifies Tridoshas . It also has Yogavahi property which helps in enhancing the properties and action of the drugs with which it combines without losing its innate properties. Studies have shown that ingestion of honey in patients with respiratory allergies, there is a marked improvement in the symptoms with significant reduction in the total symptom severity score [13] It also has antioxidant activity and stimulates immunity. Similarly, ghee in proper quantity considered as best Rasayana . It promotes lifespan and protects from many diseases. It enhances digestive power, absorption, and assimilation in the body. It alleviates Vata, Pitta and acceptable for Kapha Prakriti . It is an excellent Anupana (vehicle) for transporting herbs to the deeper tissue layers of the body. Proper digestion, absorption, and delivery to a target organ system are crucial in obtaining the maximum benefit from any therapeutic formulation; the lipophilic action of ghee facilitates transportation to a target organ and final delivery inside the cell since the cell membrane also contains lipid [14] Discussion on data related to effectiveness of treatment on clinical symptoms Data related to the effectiveness of treatment, showed that the drug was effective in reducing the severity of clinical symptoms after 45 days of intervention The group analysis of severity of sneezing by Wilcoxon Signed Rank test showed that there was highly significant response after treatment (p<0.001). After treatment it was noted that none of the subjects had severe sneezing and majority was under mild form of sneezing. A highly significant response was noted in reducing severity of nasal discharge and nasal congestion (p<0.001) after treatment. None of the participants had complaints of severe nasal discharge and nasal congestion after treatment. Majority of the children had only mild symptoms. Around 12% and 15% of the

[Find the meaning and references behind the names: Bala, Mala, Ama]

Meera S Panicker et al. Clinical efficacy of Rajanyadi Choornam in Allergic Respiratory Disease ISSN: 2456-3110 ORIGINAL ARTICLE March 2023 Journal of Ayurveda and Integrated Medical Sciences | March 2023 | Vol. 8 | Issue 3 12 total subjects were completely free from the symptoms after the treatment. The analysis of severity of cough showed that there was a highly significant response (p<0.001) after the treatment, which proved the effectiveness of the study drug in reducing cough. Majority of the study subjects had moderate (43%) and mild cough (31%). After treatment 59% of the study subjects had only mild form of cough. Subjects under the category of moderate cough also nearly reduced to half. A highly significant response to sore throat was noted (p<0.001) after the treatment. Even though majority of the participants had no complaints of sore throat even before the treatment nearly 34% had mild sore throat. After treatment, it was noted that 96.9% of the participants got completely cured from the symptom. A significant response in reducing the complaints of scratchy throat was seen after the treatment (p<0.05). Majority had no complaints and none of them had severe scratchy throat. 37% of the participants had mild symptom and after treatment it was found that 96.9% got completely cured. No significant effect in reducing the hoarseness of voice was noted in the study after the treatment (p>0.05). Only 1 among the 32 subjects presented with symptom and remaining subjects had no symptom even before the treatment. As there were no adequate positive cases, it is insignificant to interpret statistically the effect of drug in reducing hoarseness of voice. The analysis of severity of itching of eyes showed that there was significant response (p<0.05) after the treatment. Half of the subjects had mild itching and in 3% had moderate itching before the treatment. After treatment it was noted that children with mild itching of eyes reduced to 25%. 75% of children got completely cured with the symptom. There was significant reduction in the severity of most of the symptoms after the treatment. The average symptom severity total score after treatment has also significantly reduced. Comparison between before and after treatment showed a significant reduction (p<0.001) suggestive of effectiveness of the study drug in reducing the symptoms. Discussion on data related to effectiveness of treatment on haematological values The analysis of serum IgE levels and AEC levels showed significant response (p<0.001) in the comparison of values before and after treatment. The serum IgE levels which were included in the study was in a range of 60- 1000 IU/ml. The drug is found to be more effective in reducing the values which is around 1000 IU/ml. This suggested that the study drug is effective in reducing the concentration of IgE and AEC in blood. Rajanyadi Choornam is found effective in reducing most of the symptoms of Allergic Respiratory Disease. The concept of allergy is possibly explained under the concept of Ama and it has been already discussed the involvement of Agnimandya (hypo-functioning of Agni ), Ama/Ama Visha , subsequently vitiated Doshas and Dushyas, Srotovaigunya (vitiation of body channels), Pratiloma Gati of Vata (movement of Vata in opposite direction) in the pathogenesis of both Pratisyaya and Swasa . Again, children are susceptible for easy vitiation of Agni as they have a Kapha predominance and their affinities are naturally in favour of increasing Kapha , resulting in formation of Ama more easily. This persistent state of Mandagni and unaddressed already formed Ama can be attributed as the sole factors behind the onset and recurrence of the symptoms. So, improving or strengthening the status of Agni along with proper channelization of Vata and correction of deranged Srotas helps not only in controlling of symptoms but also recurrent onset of symptoms. Again, Prakruta Sleshma is considered as Bala/Ojas (immunity) [15] and when the Sleshma gets vitiated with increased production of Rasa Mala Kapha because of impaired Agni , the Sahaja Bala of the child is compromised leading to recurrent infections. The impaired transformation of Dhatus also reduces the Bala (immunity) of the child. Thus, strengthening the Agni with proper transformation of Dhatus helps in improving the immune system of the child. The drugs in the formulation have Deepana and Pachana

[Find the meaning and references behind the names: Ahmad, Richard, Sharma, Singh, Watanabe, Nakamura, Gupta, Chad, Krishna, Hunter, Mar, Pandit, Ari, Robert, Jenson, Kumari, Roy, Din, Suzuki, Ortega, Nelson, Asha]

Meera S Panicker et al. Clinical efficacy of Rajanyadi Choornam in Allergic Respiratory Disease ISSN: 2456-3110 ORIGINAL ARTICLE March 2023 Journal of Ayurveda and Integrated Medical Sciences | March 2023 | Vol. 8 | Issue 3 13 properties which can effectively handle the preexisting Ama Dosha and even prevents the further formation of Ama by stimulating and strengthening Agni . The vitiation of Vata and Kapha Dosha in the manifestation of the disease is evident from the various etiological factors mentioned in the classics. The Katu Vipaka and Ushna Veerya of the formulation eliminates the vitiated Kapha Doshas from the system clearing the obstruction in the channels. This ultimately helps in proper channelization of Vata. The Seeta nature of both Vata and Kapha Dosha is also addressed by the Usna Veerya of the formulation. Hence Rajanyadi Choornam can effectively control respiratory allergies by virtue of its Agni Deepana, Vata Kapha Hara, Vatanulomana action. The various published data on the anti-allergic, antiasthmatic, anti-tussive, anti-inflammatory and immune modulatory actions of the individual drugs in the formulation also substantiates the indications mentioned in the formulation. CONCLUSION The study drug, Rajanyadi Choornam was effective in reducing the severity of symptoms of ARD in children. Rajanyadi Choornam was effective in improving the biochemical parameters measured such as serum IgE and AEC. Rajanyadi Choornam was a simple and costeffective formulation. Rajanyadi Choornam was effective in reducing the signs and symptoms of ARD even with small doses within a short period of time. The drug was safe and hence no adverse effects were observed during the study period. The patients were strictly advised to follow the dietary restrictions and specific recommendations to avoid the etiological factors. The hypothesis of the study, Rajanyadi Choornam is effective in controlling symptoms of ARD was proved. REFERENCES 1 Sngonzález díazaarias cruzcmacouzet sánchezabpartida ortega. Impact of air pollution in respiratory allergic diseases. Medicina Universitaria. October – December 2016,;Volume 18( Issue 73 ): Pages 212-215 – science direct. 2 Robert m kliegman, Richard e behrman, Hal b jenson, Bonita f stanton. Nelson Textbook Of Pediatrics. 18 ed.). Philadelphia: Elsevier; 2008.chapter 142 page no 949 3 Zave chad. Allergies in children. Paediatr Child Healthv 6(8). 2010;6(8) 4 Vridha Jeevaka, Kasyapa Samhita or Vrddhajivakiya Tantra khila sthana, text with English translation by P.V.Tewari, Chaukambha Visva bharati, Varanasi, 1 st Edition, Reprint 2008 edition Khilasthana 3/7. 5 Vagbhata, Astanga Hridayam, , Commentary Sarvanga Sundari of Arunadata collated by Dr.Anna Moreswara Kunte and Krsna Ramachandra Shastri Navre, Edited by Pandit Harishashtri Bhishagacharya, Chowkambha Sanskrit Sansthan, Varanasi, 1 st edition, Reprint 2010, uthara sthana 2/38-40 6 Suzuki M, Nakamura T, Iyoki S, Fujiwara A, Watanabe Y, Mohri K, Isobe K, Ono K, Yano S. Elucidation of antiallergic activities of curcumin-related compounds with a special reference to their anti-oxidative activities. Biological and Pharmaceutical Bulletin. 2005;28(8):1438-43. 7 Gupta S, Walia A, Malan R. Phytochemistry and pharmacology of cedrus deodera: an overview. International Journal of Pharmaceutical Sciences and Research. 2011 Aug 1;2(8):2010. 8 Kumari N, Singh N, Singh B. s and Pharmacological activity of Pinus roxburghii-Sarg.: A Review. 9 Roy AC. Phytochemical and pharmacological investigation on the stem of piper chaba hunter.2018 mar 9(3) 10 Sharma V, Hem K, Seth A, Maurya SK. Solanum indicum Linn.: An ethnopharmacological, phytochemical and pharmacological review. Curr. Res. J. Pharm. Allied Sci. 2017;1:1-9. 11 Parmar S, Gangwal A, Sheth N. Solanum xanthocarpum (yellow berried night shade): a review. Der Pharm Lett. 2010;2(4):373-83. 12 Al-Snafi AE. The pharmacological importance of Anethum graveolens – A review. International Journal of Pharmacy and Pharmaceutical Sciences. 2014;6(4):11-3. 13 Asha’ari ZA, Ahmad MZ, Din WS, Huss in CM, Leman I. Ingestion of honey improves the symptoms of allergic rhinitis: evidence from a randomized placebo controlled

[Find the meaning and references behind the names: Zhang, Ayu, Nil, Med]

Meera S Panicker et al. Clinical efficacy of Rajanyadi Choornam in Allergic Respiratory Disease ISSN: 2456-3110 ORIGINAL ARTICLE March 2023 Journal of Ayurveda and Integrated Medical Sciences | March 2023 | Vol. 8 | Issue 3 14 trial in the East Coast of Peninsular Malaysia. Annals of Saudi medicine. 2013 Sep;33(5):469-75. 14 Sharma H, Zhang X, Dwivedi C. The effect of ghee (clarified butter) on serum lipid levels and microsomal lipid peroxidation. Ayu. 2010 Apr;31(2):134. 15 Agnivesa – Caraka Samhita – English translation by R.K Sharma and Bhagawan Dash, Reprint,2003 sutra sthana – Chapter 17/117. ******************************* How to cite this article: Meera S Panicker, Anilkumar M.V. Clinical efficacy of Rajanyadi Choornam in Allergic Respiratory Disease in Children. J Ayurveda Integr Med Sci 2023;03:1-14. http://dx.doi.org/10.21760/jaims.8.3.1 Source of Support: Nil, Conflict of Interest: None declared. Copyright © 2023 The Author(s); Published by Maharshi Charaka Ayurveda Organization, Vijayapur (Regd). This is an open-access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by-nc-sa/4.0), which permits unrestricted use, distribution, and perform the work and make derivative works based on it only for non-commercial purposes, provided the original work is properly cited

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