A Clinical Study to Evaluate the Therapeutic Effect of Drug Tagaradi Kwath in...

[Full title: A Clinical Study to Evaluate the Therapeutic Effect of Drug Tagaradi Kwath in the Management of Anidra (Insomnia) – A Research Article]

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[Find the meaning and references behind the names: Singh, Patil, Sanjay, Long, Deepak, Umesh, Mishra]

Research Article This work is licensed under a CC BY 4.0 License International Research Journal of Ayurveda & Yoga Vol. 5 (9),01-10,September,2022 ISSN: 2581-785 X; https://irjay.com/ DOI: 10.47223/IRJAY.2022.5901 A Clinical Study to Evaluate the Therapeutic Effect of Drug Tagaradi Kwath in the Management of Anidra (Insomnia) – A Research Article Sanjay Singh, 1 Deepak Sohgoura, 2 Umesh Patil, 3 Ratnaprava Mishra 4 1.P.G. Scholar, Dept. of Kayachikitsa, Shubhdeep Ayurved Medical College and Hospital, Indore (M.P.). 2.Professor, Dept. of Kayachikitsa, Shubhdeep Ayurved Medical College and Hospital, Indore (M.P.). 3.Associate Professor, Dept. of Kayachikitsa, Shubhdeep Ayurved Medical College and Hospital, Indore (M.P.). 4.Medical superintendent, HOD and Professor, Dept. of Kayachikitsa, Shubhdeep Ayurved Medical College and Hospital, Indore (M.P.) INTRODUCTION Sleep is a natural state of physiology of the body, which is characterized by a temporary unconsciousness, withdrawal from the contact with the worldly objects and which maintains the nourishment or the anabolic activities of the body, relaxes the mind, refreshes the individual and keeps him fit and which has been stated to enhance the longevity of the human beings. While Insomnia or sleeplessness is a sleep disorder in which people have trouble sleeping. They may have difficulty falling asleep, or staying asleep as long as desired. Insomnia can be short term, lasting for days or Article Info Article history: Received on: 17-07-2022 Accepted on: 06-09-2022 Available online: 30-09-2022 Corresponding author- Sanjay Singh, P.G. Scholar, Dept. of Kayachikitsa, Shubhdeep Ayurved Medical College and Hospital, Indore (M.P.) Email: sskrishna 303@gmail.com ABSTRACT: Anidra (Insomnia) is a type of sleep disorder in which individual feels difficulty in falling asleep, staying asleep or both. In Ayurveda, Anidra is indicated as Vata Nanatmaja Vikara by Acharya Charaka . Insomnia affects most of the people at any stage of life due to today’s stressful day to day life. Allopathic hypnotic drugs are used to treat insomnia in acute stage, but long-term use can lead to dependency and withdrawal symptoms along with other side effects. In present study a polyherbal compound Tagaradi kwath consist extracts of Tagara, Turagagandha, Parpati, Shankhpushpi, Tridasavitapi, Tikta, Bharti (brahmi), Bhutakesi, Jaladhara, Krtamala, Cetaki and Gostana is used to check its efficacy in the management of insomnia. Aim: A clinical study to evaluate the therapeutic effect of drug Tagaradi kwath in the management of Anidra (Insomnia). Materials and methods : Total 30 newly diagnosed patients of age group 15 to 70 years of insomnia who were not taking any other hypnotic medicine were selected and administered 50 ml of Kwath at bedtime for 1 month. Assessment was done considering the overall improvement of sleep quality according to Athens Insomnia Rating Scale, improvement in associated complains, relieving of anxiety and depression. Observations : The information gathered on the basis of observations was subjected to statistical analysis. The Paired ‘t’ test was used to check the significance of objective criteria. Results: The results showed that the trial drug had Significant effect on almost all the mentioned parameters of Insomnia. Keywords : Nidra , Anidra, Tagaradi kwath , sleep, Insomnia

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[Find the meaning and references behind the names: Man, Raja, Guna, Good]

Sanjay et. al “A Clinical Study to Evaluate the Therapeutic Effect of Drug Tagaradi Kwath in the Management of Anidra (Insomnia) – A Research Article.” : 2022; 5 (9):01-10 2 weeks, or long term, lasting more than a month. According to the statistics 20% - 40% adults, encounter insomnia problems during a year time 1 Especially 15 to 55 years old are more affected. Further, Insomnia is 1.4 times more common in woman than in men and affects 1 in 3 people 2 The term insomnia is used in a selection of methods within the medical literature and popular press. Most usually, insomnia is described with the aid of the presence of a man or woman’s file of issue with sleep. As an example, in survey studies, insomnia is described by a fantastic reaction to both questions, “Do you revel in trouble napping?” or “Do you have difficulty falling or staying asleep?” In the sleep literature, insomnia is occasionally used as a time period to describe the presence of polysomnographic evidence of disturbed sleep. For this reason, the presence of a long sleep latency, common nocturnal awakenings, or extended durations of wakefulness at some stage in the sleep period or even common transient arousals are taken as proof of insomnia. As a consequence, insomnia has been notion of both as a symptom and as a sign. Ayurveda is an ancient science of life, which deals with body, mind and soul. Ayurveda has described two types of Doshas (Humoral factors) i.e. Sharirik and Mansik which are further subdivided into three Sharirik doshas i.e. Vata, Pitta, Kapha and two Mansik doshas i.e. Tama and Raja . While Satva is a guna , this humoral factor has only positive activity on the body 1 If all of these factors are in equilibrium state that means an individual has healthy body and mind. But when these factors get vitiated then disease process starts 3 Aahara (food), Nidra (sleep), Brahmacharya (celibacy) are described to be the Trayopasthambas (three supportive pillars) of life and so, sleep is one of the essential factors to lead a healthy life 4 It has been rightly stated by Acharya Charak that happiness and misery, proper and improper growth, good strength and weakness, potency and sterility, knowledge and ignorance, life and death of an individual depends on the quality of sleep 5 Nidra - Acharya Charaka and the commentator Chakrapani explained that the man sleeps when his mind is exhausted and his exhausted sense organs detract from their objects. Sleep- According to modern science various type of definitions are mentioned by the scientists like- Sleep is defined as unconsciousness from which the person can be aroused by sensory or other stimuli 6 Sleep can be defined as a state of consciousness that differs from alert wakefulness by a loss of critical reactivity to events in the environment with a profound alteration in the function of the brain 7 Anidra - Acharya Charak included the Asvapna in 80 Nanatmaja vata vikaras . Acharya Sushruta explained vaikariki nidra in chapter Garbha vyakarana shariram which can be correlated to sleep disorder. In the context to relation between body and mind, Ayurveda emphasizes that Sharira and Satva –both interacts with one another in all spheres of life 8 . We find a rich material which establishes that the Ayurvedic approach to the disease is definitely psychosomatic in nature. It has been shown that Sharirik dosha also affect the Mansik conditions. For example, with increasing Vata there happens Anidra 9 . On the other hand, the effects of psychic disorders on the body have been also mentioned: Vayu is provoked by Kama, Shoka, Bhaya , Pitta is deranged by krodha 10 The interplay between the body and mind is the core of Samprapti of every Manasa roga. Though, Anidra is considered under Vataja Nanatmaja roga , here it is better to consider it as Vataja Manasika Nanatmaja roga . Even though, it is Vataja Vikara , in the pathogenesis of Anidra , the Manasika Dosha Rajas plays an important role. Broadly, the etiological factors of Anidra can be categorized in two headings, viz. Sharirika and Manasika . The former category comprises Shodhana Atiyoga, Vyayama, Upavasa , dietary articles and routine activities causing Vata-pitta vitiation etc. On account of mental dispositions such as Chinta, Krodha, Bhaya and Shoka, Vata Prakopa takes place in addition to the physical factors. The Vata vitiation occurs, due to both kinds of etiological categories. In comparison to the therapeutic procedure of different systems of medicine, Ayurveda has a very good approach towards the treatment of Anidra (insomnia). The deeds of substances present in Tagaradi kwath which is selected for this study are like Vata-Pitta hara ( Draksa ), Vata hara ( Tagar, Asvagandha, Devadaru ), Pitta hara ( Parpata, Kutki, Brahmi, Mustaka, Aragvadha ), Tridosahara ( Sankhapuspi, Jatamansi, Haritki ), Medhya ( Sankhapuspi, Brahmi, Jatamansi ), Rasayana ( Asvagandha, Haritki ), Anulomana ( Haritki ), Balya ( Asvagandha, Jatamansi ) etc. Due to above deeds Samprapti of Anidra can be broken down, Because of this Tagaradi kwath is selected to evaluate the therapeutic effect on management of Anidra . Therefore, the present study entitled “A Clinical Study to Evaluate the Therapeutic effect of Drug Tagaradi kwath in the management of Anidra (Insomnia)” has been under

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Sanjay et. al “A Clinical Study to Evaluate the Therapeutic Effect of Drug Tagaradi Kwath in the Management of Anidra (Insomnia) – A Research Article.” : 2022; 5 (9):01-10 3 taken. The present study is planned with following Aim and Objectives- AIM A Clinical Study to Evaluate the Therapeutic effect of Drug Tagaradi Kwath in the management of Anidra (Insomnia). OBJECTIVES 1- To evaluate the effect of Tagaradi kwath in the management of Anidra . 2- Etiopathogenesis of Anidra as per Ayurveda and Modern literature. 3- Time of the sleep 4- Evaluation for depression and anxiety 5- Athens Insomnia Scale Study Design This is randomized, observational, interventional and clinical study. METHODOLOGY Clinical Study Material Patients suffering from Anidra. Tagradi kwath Method Of Selection Total 30 patients had selected to fulfilling the criteria for inclusion of Anidra from OPD and IPD of Kayachikitsa , Shubhdeep Ayurved Medical College and Hospital Indore. For diagnosis, a detailed medical history and physical examination of the patients according to both modern and ayurvedic clinical methods had done. A detailed interview had conducted to elucidate sleep problems, social problems, and other areas of functioning etc. To assess the Psychological intactness, the mental status examination had carried out. To confirm or exclude the other medical disorders, routine hematological and urine investigations had carried out. A special proforma had prepared with a gradation of symptoms and scoring had done by adopting Athens Insomnia Scale. Inclusion Criteria 1) Patients of Anidra suffering upto 6 months of duration. 2) Patients of either sex between the age group 15 to 70 years. 3) Nidranasha with generalized anxiety mild or moderate according to Athens Insomnia Scale. 4) Patients without any complication of other diseases had included in this study. Exclusion Criteria 1) Anidra (insomnia) due to other conditions such as Madatyaya (alcoholism), Abhighata (injury), and other systemic diseases. 2) Patients on hypnotic medicine or other drugs known to cause drowsiness. 3) Patients with acute illness like myocardial infraction (MI), Congestive cardiac failure (CCF), COPD, Meningitis, acute pain condition and similar other disease. 4) Patients with major psychiatric illness like epilepsy, schizophrenia, major depressive psychosis etc. 5) Patients having chronic disease like liver cirrhosis, asthma, malignancies, Diabetes, Hypertension and Chronic renal failure. Trial Drug Details: Drug and Posology: Tagaradi Kwath (Table No. 1) Intake of the decoction of Tagara, Turagagandha, Parpati, Shankhpushpi, Tridasavitapi, Tikta, Bharti (brahmi), Bhutakesi, Jaladhara, Krtamala, Cetaki and Gostana cures Pralapaka (sannipataja fever) very soon 11 . Quantity- Each ingredient had taken in equal amount and kwath had prepared according to kwath kalpna described in Sharangdhara Kwath Preparation- Take 5 gm of Kwath dravya and boiled with 200 ml of water, reducing till 50 ml, filtered it, and takes it lukewarm at the time of bed Research Methodology 1) STUDY TYPE: open clinical trial 2) SAMPLE SIZE: 30 subjects 3) NO. OF GROUP: 1 4) STUDY SITE: OPD and IPD of Kayachikitsa Department of Shubhdeep Ayurved Medical College & Hospital (P.G. Institute), Village- Datoda , Khandwa rode Indore (M.P.) 452020. 5) DIET ADVICE: Pathya Aahar Sample Size Total 30 patients Ethical clearance no . EC/2020/03 dated-13/01/2020 CTRI no:- CTRI/2021/09/036371 Procedure Planned After randomly selection of patients, drug had given to every patient for 30 days and patient had followed every 15 days to see the effect of Tagaradi kwath in Anidra . Investigation EEG (If necessary) CBC (if necessary)

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[Find the meaning and references behind the names: Shikha, Muslim, Anup]

Sanjay et. al “A Clinical Study to Evaluate the Therapeutic Effect of Drug Tagaradi Kwath in the Management of Anidra (Insomnia) – A Research Article.” : 2022; 5 (9):01-10 4 Data Collection And Method Depending upon subjective and objective parameters, assessment of response had made based on gradation index mentioned below, before and after treatment. Subjective Criteria- It has been taken according to Vagbhatta 12 1) Angmarda 2) Sirogaurva 3) Jrumbha 4) Jadyata 5) Bhrama 6) Tandra Objective Criteria 1) Time of the sleep 2) Evaluation for depression and anxiety 3) Athens Insomnia Scale Criteria Of Assessment (Table No. 2) A multidimensional scoring pattern had adopted for the sign and symptoms of Nidranasha mention in Ayurvedic texts. Statistical Analysis Plan Appropriate statistical test had applied as per requirement. The information collected on the basis of observation made during the treatment are analyses on a Statistical criteria in terms of mean score (B.T. & A.T.), Standard Deviation (S.D), Standard Error (S.E.) and Paired T Test was carried at the significance level of 0.05, 0.01, 0.001, thus the obtained results were interpreted as: • P> 0.05 Insignificant • P< 0.05 Significant • P< 0.01 Highly Significant • P< 0.001 Extremely significant OBSERVATIONS It was found that maximum number of patients i.e. 40 % belonged to age group of 41–50 years, followed by 26.66% 31-40 years, 16.66% of patients to each in 17-30 years and 51-60 years age group. In this study, the majority of the patients were male i.e. 53.33%, while the remaining i.e. 46.66% were female. Maximum i.e. 90% of patients were Hindus, 6.66% were Muslim and 3.33 were Sikha . It was found that maximum number of patients i.e. 92.5% were married, while 7.5% Patients were Unmarried. Amongst 30 patients 16.66% were having secondary level and higher secondary of education and 43.33% were having graduate education, 6.66% were having uneducated. Maximum i.e. 40.00% of patients were belonging to middle class, 26.66% were from lower middle class and minimum 13.33% were belonging to poor of society. The data of the present study shows that most of the patients, i.e. 70% were belonging to rural habitat while remaining 30% were from urban habitat. Maximum i.e. 53.33% patients were mixed; while 46.66% were habituated to vegetarian type of diet. Dietary habit of 30 Patients, Among them 33% of Patients were taking in Adhyashana diet, while 6.66% were having Samashana and 20% were having Visamashana, Anashana and Viruddha Ahara respectively. Majority of the patients i.e. 53.33% were of Mandagni , and 46.66% of patients were observed to having Vishamagni . Maximum i.e. 100% of patients were from Sadharana Desha followed by 00% patients were from Jangala and Anup . In the present study, the available data reveals that maximum numbers of patients i.e. 80.00% were having addiction of tea, 26.66% were having addiction of smoking, 33.33% were having addiction of tobacco and 20% were having addiction of alcohol. Out of 30 patients, 80% patients were having regular bath habits whereas 20% patients were having irregular bath habit. Data reveals that maximum patients were doing no exercise, 20% were doing regular exercise and 80% irregular exercise in their routine habit. Among the 30 patients, 80% patients were of Vata pitta Prakriti , 13.33% were Vata Prakriti and 6.66% patients were Vata kapha Prakriti . Out of 30 patients, 66.66% patients were Madhyama Samhanana whereas 33.33% patients were Avara Samhanana , Pravara Smahanana was not found in any patient. Majority of the patients 86.66% were Madhyama in Pramana 13.33% patients were Avarapramana. Out of the 30 patients of Anidra , 60% patients were having MadhyamaSatva , 33.33% AvaraSatva and 6.66% patients were having PravaraSatva. The data shows that, maximum i.e. 86.66% patients were Madhyamsatmya and 13.33% patients were Avarasatmya. Outcomes With In All Likelihood Explanation Of Mode Of Movement Of Tagaradi Kwath Effect of Tagardi kwath on Subjective Criteria (Table No. 3) Effect on Angmarda : The mean initial score of Angamarda was 1.267, which reduced to 0.700 after treatment. There is relief of 44.73% in Angamarda . Statistical analysis shows that result was significant at the level P <0.0001 with ‘t’ value 5.461. Tagaradi kwath does Suddhi of Koshtha due to its Anuloman property, when the Kostha is purified, Srotosang disappears and Vata moves freely in koshtha , so Angamarda disappears. Effect on Sirogaurava : In the initial phase the mean score was 1.800, which showed diminution to 0.833 after the therapy. There is relief of 53.70% in Sirogaurava . Statistical manipulation

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Sanjay et. al “A Clinical Study to Evaluate the Therapeutic Effect of Drug Tagaradi Kwath in the Management of Anidra (Insomnia) – A Research Article.” : 2022; 5 (9):01-10 5 shows to be significant with ‘t’ value of 9.522 at the level of P<0.0001. Tagara has pharmacological action on nervous system as analgesic or anodyne, anticonvulsant, brain tonic and pacifying as well as tranquilizer agent, and the rhizomes are hence, orally given in the ailments of mental unrest, insomnia, insanity and other mental as well as psychic problems in Ayurvedic system of medicine. Due to sedative effect of Jatamansi, Shankhpushpi and Bramhi its release mental pressure so removes Sirogaurav . Effect on Jrumbha : The mean score at preceding the treatment was 0.433 which regressed to 0.2661 after treatment. There is relief of 38.46% in Jrumbha . The difference was found to be significant at the level of P 0.0029 with ‘t’ value of 2.408. Tagaradi kwath does Srotosuddhi and Anulomana of Vata which removes insomnia and also jrumbha . Effect on Jadyata : The mean score at preceding the treatment was 1.033, which regressed to 0.433 after treatment. There is relief of 50.66% in Jadyata . The difference was found to be significant at the level of P <0.0001 with ‘t’ value of 4.871 . Tagaradi kwath have Antiarthritic, Rasayan agent like Ashwagandha , Appetizer, Yakruttejaka , Bhedaniya agent like Katuka , Anulomaniya agent like Haritki which done Aampachana and kostha sothana , which removes jadyata . Effect on Bhrama : The mean score at preceding the treatment was 0.733, which regressed to 0.400 after treatment. There is relief of 45.45% in Bhrama . The difference was found to be significant at the level of P 0.0099 with ‘t’ value of 2.763. Tagaradi kwath ingredients like Tagar, Bramhi, Ashwagandha, Jatamansi and Shankhpushpi have Medhya , Nervine tonic and also sedative properties which removes Bhrama . Effect on Tandra: The mean score at preceding the treatment was 0.700, which regressed to 0.333 after treatment. There is relief of 52.54% in Tandra . The difference was found to be significant at the level of P<0.0001 with ‘t’ value of 4.097. Tagaradi kwath ingredients like Tagar, Parpat, Bramhi, Ashwagandha, Jatamansi and Shankhpushpi have Medhya , Nervine tonic and also Sedative properties and Kutki have Rechana or Haritki have Anulomana properties which removes Srotosang due to which sleep comes and Tandra is removed. Effect of Tagaradi Kwath on Athens Insomnia Scale (Table No. 4) Effect on Sleep Induction: The mean score at preceding the treatment was 0.8667, which decreased to 0.500 after treatment. There is relief of 42.30% in Sleep Induction. The difference was found to be significant at the level of P<0.0028 with ‘t’ value of 3.266. Sedative properties of Tagar, Parpat, Bramhi, Ashwagandha, Jatamansi and Shankhpushpi remove anxiety and depression and helpful in sleep induction. Effect on Awakenings During The Night: The mean score at preceding the treatment was 0.700, which decreased to 0.500 after treatment. There is relief of 28.57% in Awakenings During The Night. The difference was found to be significant at the level of P<0.0314 with ‘t’ value of 2.262. Sedative, nervine tonic, and also tranquilizer properties of Tagar, Parpat, Bramhi, Ashwagandha, Jatamansi and Shankhpushpi remove anxiety and depression and helpful to reduce awakening during the night. Effect on Final Awakening Earlier Than Desired: The mean score at preceding the treatment was 0.633, which increased to 0.400 after treatment. There is relief of 38.84% in Final Awakening Earlier Than Desired. The difference was found to be significant at the level of P<0.0059 with ‘t’ value of 2.971. Sedative properties of Tagar, Parpat, Bramhi, Ashwagandha, Jatamansi and Shankhpushpi remove anxiety and depression and effective in final awakening earlier than desired. Effect on Total Sleep Duration: The mean initial score of Total Sleep Duration was 1.400, which reduced to 0.633 after treatment. There is relief of 54.76% in Total Sleep Duration. Statistical analysis shows that result was highly significant at the level P <0.0001 with ‘t’ value 6.707. Sedative, nervine tonic, and also tranquilizer property of Tagar, Parpat, Bramhi, Ashwagandha, Jatamansi and Shankhpushpi removes Anidra and improves total sleep duration. Effect on Overall Quality Of Sleep: In the initial phase the mean score was 1.367, which showed diminution to 0.600 after the therapy. There is relief of 56.97% in Overall Quality Of Sleep. Statistical manipulation shows to be highly significant with ‘t’ value of 8.332 at the level of P<0.0001. Sedative, nervine tonic, and also tranquilizer properties of Tagar, Parpat, Bramhi, Ashwagandha, Jatamansi and Shankhpushpi removes Anidra and improve overall quality of sleep. Effect on Sense of Bell-Being During The Day: The mean score at preceding the treatment was 0.466, which increased to 0.266 after treatment. There is relief of 42.85% in Sense Of Bell-Being During The Day. The difference was found to be significant at the level of P<0.0117 with ‘t’ value of 2.693. Rasayan guna of Ashwagandha removes general disability and sedative, nervine tonic, and tranquilizer property of Tagar, Parpat, Bramhi, Jatamansi and Shankhpushpi removes Anidra and he/she feel fresh, energetic and sense of bell-being during the day. Effect on Functioning During The Day: The mean initial score of Functioning During The Day was 0.8667, which reduced to 0.600 after treatment. There is relief of 30.76% in

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[Find the meaning and references behind the names: Lama, Main, Pandey, Nil]

Sanjay et. al “A Clinical Study to Evaluate the Therapeutic Effect of Drug Tagaradi Kwath in the Management of Anidra (Insomnia) – A Research Article.” : 2022; 5 (9):01-10 6 Functioning During The Day. Statistical analysis shows that result was significant at the level P <0.0029 with ‘t’ value 0.0029. When Anidra and General disability are over, the person’s ability to work increases during the day. Effect on Sleepiness During The Day In the initial phase the mean score was 0.2667, which showed diminution to 0.1667 after the therapy. There is relief of 37.5% in Sleepiness During The Day. Statistical manipulation shows to be insignificant with ‘t’ value of 1.361 at the level of P<0.1841. When patient’s sleep is complete at night, he/she feel fresh and energetic during the day so his sleepiness ends. Overall effect of treatments (Table No. 7) In this study 13 patient’s attained moderate improvement while 12 patients attained mild improvement and 5 patients attained no improvement. DISCUSSION Anidra (Insomnia) as explained in Ayurveda classical texts is evidently a disease of Vata Natatmaj Vikara , disease of Manovaha shrotasa and it is a psychosomatic disease. Vata-Pitta along with Rajasa play a key role in the etiopathogenesis of Anidra Manasika Nidanas as well as psychic stress are the main causative factors of the disease Anidra . Nidra – An essential phenomenon for maintenance and restoration of the life, which is considered under Trayopastambha . Proper sleep provides balance of the body constituents, alertness, good vision, good complexion, fired digestive power as well as happiness, vigor, virility, nutrition and long life. Tagaradi kwath is a complex form of all an anti-anxiety and anti-stress drug with adoptogenic properties resulting in producing better sleep and important work performance. The deeds of substances present in Tagaradi kwath which is selected for this study are like Vata-Pitta hara ( Draksa ), Vata hara ( Tagar, Asvagandha, Devadaru ), Pitta hara ( Parpata, Kutki, Brahmi, Mustaka, Aragvadha ), Tridosahara ( Sankhapuspi, Jatamansi, Haritki ), Medhya ( Sankhapuspi, Brahmi, Jatamansi ), Rasayana ( Asvagandha, Haritki ), Anulomana ( Haritki ), Balya ( Asvagandha, Jatamansi ) etc. Due to above actions, the Samprapti of insomnia was broken. Out of 30 patients, 13 patient’s attained moderate improvement while 12 patients attained mild improvement and 5 patients attained no improvement. Most of the patients responded to the treatment with significant improvement in both subjective and objective parameters. There was no adverse drug reactions (ADR) and LAMA found during the study. On the basis of clinical study we can conclude that Tagaradi kwath is clinically effective in the management of Anidra . CONCLUSION Tagaradi kwath is a complex form of all an anti-anxiety and anti-stress drug with adoptogenic properties resulting in producing better sleep and important work performance. All the drugs chosen for the study were having Vednasthapak, Vata dosha avasadak , Rejuvenating, Adaptogenic and Antistress properties in nature. The drugs are easily available, cheaper and with no side and adverse effect. There is sufficient evidence provided by this study that Tagar , Ashwagandha and and Jatamanshi have positive role in the management of Anidra . Tagaradi Kwath has shown better results in the overall recovery of the patient may be due to tranquilizing effect of Tagaradi kwath . On the basis of clinical study, we can conclude that Tagaradi kwath is clinically effective in management of Anidra . Acknowledgements - Nil Conflict of interest - None Source of finance & support - Nil ORCID Sanjay Singh , https://orcid.org/ 0000-0001-6429-4982 REFERENCES 1 Ford D, Kamerow D. Epidemiology study of sleep disturbances and psychiatric disorders. IAMA 2011; 262: 1479-84. 2 World Health Organization [Internet]. Geneva: Several Sleep disorders Reflect Gender Differences, [updated 2007 May 18; cited 2012 Aug 21]. Available from: http://psychnews.psychiatryonline.org/newsarticle.aspx?ar ticeid=110961. 3 Pandey K, Caraka Samhita, Vidyotini Hindi Commentary Part -1 st Charak sutra 1/57 Published By Chaukhambha Bharati Academy Varanasi, Reprint Year-2017.pp.32 4 Shastri AD, Susruta Samhita, Ayurveda Tattva Sandipika Hindi Commentary Part- 1 st Susruta sutra 15/48 Published By Chaukhambha Sanskrit Sansthan Varansi, Reprint Year-2017.pp.84 5 Pandey K, Caraka Samhita, Vidyotini Hindi Commentary Part -1 st , Charak sutra 11/35 Published By Chaukhambha Bharati Academy Varanasi, Reprint Year-2017.pp.227

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[Find the meaning and references behind the names: Kumari, Nirmala]

Sanjay et. al “A Clinical Study to Evaluate the Therapeutic Effect of Drug Tagaradi Kwath in the Management of Anidra (Insomnia) – A Research Article.” : 2022; 5 (9):01-10 7 6 Goyton C, Text Book Of Medical Physiology Eleventh Edition Reprinted Year-2006 7 Chatterjee C, Human Physiology, Published By Kalyani Mukherjee For And On Behalf Of Medical Allied Agency Kolkata, Reprinted Year-2004 8 Pandey K, Caraka Samhita, Vidyotini Hindi Commentary Part -1 st Charak sutra 21/57 Published By Chaukhambha Bharati Academy Varanasi, Reprint Year-2017.pp.418 9 Pandey K, Caraka Samhita, Vidyotini Hindi Commentary Part -1 st , Charak shareer 4/36 Published By Chaukhambha Bharati Academy Varanasi, Reprint Year-2017.pp.879 10 Shastri AD, Susruta Samhita, Ayurveda Tattva Sandipika Hindi Commentary Part- 1 st Susruta sutra 15/18 Published By Chaukhambha Sanskrit Sansthan Varansi, Reprint Year-2017.pp.78 11 Kumari A, Yogaratnakara Part-1 st Edited And Translated Y.R. 2/322 Published By Chaukhambha Visvabharati First Edition-2010. 12 Tripathi B, Astanga Hrdayam, Nirmala Hindi Commentary Part-1 st , A.H.Su. 7/64 Published By Chaukhamba Sanskrit Pratishthan Delhi, Reprinted Year-2011.pp.131 How to cite this article: Singh S, Sohgoura D, Patil U, Mishra R “A Clinical Study To Evaluate The Therapeutic Effect Of Drug Tagaradi Kwath In The Management Of Anidra (Insomnia) – A Research Article ” IRJAY.[online]2022;5(9); 01-10 Available from: https://irjay.com DOI linkhttps://doi.org/10.47223/IRJAY.2022.5901

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Sanjay et. al “A Clinical Study to Evaluate the Therapeutic Effect of Drug Tagaradi Kwath in the Management of Anidra (Insomnia) – A Research Article.” : 2022; 5 (9):01-10 8 Table No. 1: showing part used of ingredients taken in tagaradi kwath S.NO INGREDIENT LATIN NAME PART USED 1 Tagar Valeriana wallichii Mool 2 Ashwagandha Withania somnifera Mool 3 Pittapapda Fumaria parviflora Panchaang 4 Sankhapushpi Convolvulus pluricaulis Panchaang 5 Devdaru Cedrus deodara Kaandsar 6 Kutki Picrorhiza kurroa Mool 7 Bramhi Centella asiatica Panchang 8 Jatamansi Nordostachys jatamansi Mool 9 Nagarmotha Cyperus rotundus Kaand 10 Amaltas Cassia fistula Phal majja 11 Haritaki Terminalia chebula Phal 12 Draksha Vitis vinifera Phal (Table No. 2) - CRITERIA OF ASSESSMENT A multidimensional scoring pattern had adopted for the sign and symptoms of Nidranasha mention in Ayurvedic texts Absence of symptoms 0 Mild degree 1 Moderate degree 2 Severe 3 Table No. 3: Effect of Tagardi kwath on subjective criteria Sign& Symptoms Mean Score % Of Relief S.D. SE T N P Df B.T. A.T. Angamarda 1.800 0.833 44.73 0.5683 0.1038 5.461 30 <0.0001 29 Sirogaurava 1.800 0.833 53.70 0.5561 0.1015 9.522 30 <0.0001 29 Jrumbha 0.433 0.2661 38.46 0.3790 0.0692 2.408 30 0.0029 29 Jadyata 1.033 0.433 58.66 0.6747 0.1232 4.871 30 <0.0001 29 Bhrama 0.733 0.400 45.45 0.6609 0.1207 2.763 30 0.0099 29 Tandra 0.700 0.333 52.54 0.4901 0.0894 4.097 30 <0.0001 29

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Sanjay et. al “A Clinical Study to Evaluate the Therapeutic Effect of Drug Tagaradi Kwath in the Management of Anidra (Insomnia) – A Research Article.” : 2022; 5 (9):01-10 9 Table No. 4: Effect of Tagaradi Kwath on Athens Insomnia Scale Objective Criteria Mean Score % Of Relief S.D. SE T N P Df B.T. A.T. Sleep Induction 0.8667 0.500 42.30 0.6149 0.1123 3.266 30 0.00028 29 Awakenings During The Night 0.700 0.500 28.57 0.4842 0.0884 2.262 30 0.0314 29 Final Awakening Earlier Than Desired 0.6335 0.400 36.84 0.4302 0.0785 2.971 30 0.0059 29 Total Sleep Duration 1.400 0.6333 54.76 0.6261 0.1143 6.707 30 <0.0001 29 Overall Quality Of Sleep 1.367 0.600 56.97 0.5040 0.0922 8.332 30 <0.0001 29 Sense Of Bell-Being During The Day 0.4067 0.2667 42.85 0.4068 0.0742 2.693 30 0.0117 29 Functioning During The Day 0.8667 0.600 30.76 0.4498 0.6822 3.247 30 0.0029 29 Sleepness During The Day 0.2667 0.1667 37.50 0.4026 0.0735 1.361 30 0.1841 29 Table No. 5: Percentage of Relief In Subjective Criteria Sign & Symptoms Percentage Of Relief Angamarda 44.73 Sirogaurava 53.70 Jrumbha 38.46 Jadyata 58.66 Bhrama 45.45 Tandra 52.54 Table No. 6: Percentage of Relief In Objective Criteria Sign & Symptoms Percentage Of Relief Sleep Induction 42.30 Awakenings During The Night 28.57 Final Awakening Earlier Than Desired 36.84 Total Sleep Duration 54.76 Overall Quality Of Sleep 56.97 Sense Of Bell-Being During The Day 42.85 Functioning During The Day 30.76 Sleepness During The Day 37.50

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Sanjay et. al “A Clinical Study to Evaluate the Therapeutic Effect of Drug Tagaradi Kwath in the Management of Anidra (Insomnia) – A Research Article.” : 2022; 5 (9):01-10 10 Table No. 7: Overall effect of treatments: Status Effect of Tagaradi Kwatha No. of Patients Percentage Complete remission 0 0% Markedly improved 0 0% Moderately Improved 13 43.33% Mild improved 12 40% No improvement 5 16.66% Graph No. 1: showing overall effect of therapy Status 0% Complete remission 0% Markedly improved 0% Moderately Improved 43% Mild improved 40% No improvement 17% Effect of Tagaradi Kwatha Status Complete remission Markedly improved Moderately Improved Mild improved No improvement