Randomized parallel group clinical trial to evaluate the efficacy of...

[Full title: Randomized parallel group clinical trial to evaluate the efficacy of Virechana Karma and Khanda Pippali Avaleha in Amlapitta]

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Publisher E-ISSN:2456-3110 Maharshi Charaka Ayurveda www.maharshicharaka.in Journal of Ayurveda and Integrated Medical Sciences 2021 Volume 6 Number 1 Jan-Feb Research Article Clinical Trial Randomized parallel group clinical trial to evaluate the efficacy of Virechana Karma and Khanda Pippali Avaleha in Amlapitta Chauhan A.1*, Srivastava A.², Rohilla P.3 DOI: 10.21760/jaims.6.1.1 1* Anshul Chauhan, Assistant Professor, Dept. of Panchakarma, Gaur Brahman Ayurvedic College, Rohtak, Haryana, INDIA. 2 Alok kumar Srivastava, Professor, Dept. of Panchakarma, Faculty of Ayurved, Main Campus, UAU, Dehradun, Uttarakhand, INDIA. Pooja Rohilla, Assistant Professor, Dept. of. Dravya Guna, Baba Mastnath Ayurvedic College, Rohtak, Haryana, INDIA. Introduction: Amlapitta is the result of faulty food habits and life style. Acid Reflux disease have similarity with Gastritis. Material and methods: 50 patients having Amlapitta's symptoms for at least 4 months and on at least 5 of the 7 days prior to screening, also fulfilling the criteria were selected (Group A- 25, Group B-25) and parallel randomized in two groups. Intervention given as Virechana Karma followed by placebo capsules for 45 days in Group A and Khanda Pippali Avaleha in the dose of 10 gram/day twice in a day after meal with lukewarm water in Group B for 60 days. The primary endpoint was the 14-item self-administered questionnaire dimension score on cardinal symptoms of Amlapitta. Obtained results were analyzed statistically by independent sample "t" test for difference in group A and B. Wilcoxon sign rank was used within group comparison. Result & discussion: Both the interventions were highly significant in both the groups but when compare the mean percent change relief was found more in Group A than Group B in Daha and Avipaka. Overall, Virechana and Khand Pippali Awaleha can be better treatment modality in the management of Amlapitta. Keywords: Amlapitta, Acid reflux syndrome, Khanda Pippali Avaleha, Virechana Corresponding Author Anshul Chauhan, Assistant Professor, Dept. of Panchakarma, Gaur Brahman Ayurvedic College, Rohtak, Haryana, INDIA. Email: dr.anshul17@gmail.com How to Cite this Article Anshul Chauhan, Alok kumar Srivastava, Pooja Rohilla, Randomized parallel group clinical trial to evaluate the efficacy of Virechana Karma and Khanda Pippali Avaleha in Amlapitta. J Ayu Int Med Sci. 2021;6(1):01-06. Available From https://www.jaims.in/index.php/jaims/article/view/1 174 To Browse Manuscript Received 2021-01-08 Review Round 1 2021-01-17 Review Round 2 2021-01-28 Review Round 3 2021-02-05 Accepted 2021-02-12 Conflict of Interest Ethical Approval Plagiarism X-checker Note Nil Yes 16% Funding Nil 2021 by Anshul Chauhan, Alok kumar Srivastava, Pooja Rohilla and Published by Maharshi Charaka Ayurveda Organization. This is an Open ACCESS Access article licensed under a Creative Commons Attribution 4.0 International License https://creativecommons.org/licenses/by/4.0/ unported [CC BY 4.0]. Journal of Ayurveda and Integrated Medical Sciences 2021;6(1) (cc) 0 01

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Anshul et al. Randomized parallel group clinical trial in Amlapitta Introduction Approximately 80% of the top ten life threatening diseases of the world are due to faults in dietary habits[1] and Amlapitta is also one of them.[2] The signs and symptoms (acid regurgitation, nausea, heart burn etc.) of Amlapitta [3] are very much similar to Acid-reflux disorders such as acute gastritis, Gastro- oesophageal reflux disease, Nonulcer dyspepsia etc. The incidence of gastritis in India is approximately 3 in 869 that is about 12,25,614 people suffering from gastritis out of the total 1,06,50,70,607 population. Due to Dyspepsia a large proportion of patients are visiting gastroenterology clinics.[4],[5] A study from India reported prevalence of dyspepsia to be 30.4%.[6] The overall prevalence of GERD was 7.6%: 6.7% in northern India and 8.4% in the southern parts.[7] Various treatment given in modern science but only inhibit the acid release for certain period and remission of symptoms occurs after withdrawal of medicine. Prolonged use of PPIs may increase the risk of clostridium difficile infection of the colon, heart attacks, hypomagnesaemia. Thus, to combat these hazardous side effects, there is need to search a safe remedy with less side-effects and herbal drugs. Khanda Pippali Avaleha (KPA) [8] as Sanshaman yoga was taken because of ingredients having Sheeta virya, Madhura vipaka which directly pacifies the abnormal Pitta. Virechana was selected as a Sanshodhan procedure as it has effect on Agnisthana which is hampered in Amlapitta. Virechana karma is indicated for the treatment of Amlapitta.[9] Aim and Objective To evaluate the efficacy of Virechana Karma and Khanda Pippali Avaleha in the management of Amlapitta. Materials and Methods Type of Trial: Interventional Participants and study design It was a randomized, non-blinded, two armed, parallel-group, clinical trial conducted in the Panchkarma and Kaya-chikitsa Department of Rishikul Campus, Haridwar, between March 2016 and November 2018. Participants were 2 Udaradhmana Recruited from among patients attending the OPD, IPD or individuals who visited the department to participate in the trial. The trial included individuals who were between 20 and 60 years old (inclusive), who had a diagnosis of uncomplicated symptomatic GERD without the metabolic complications as well as a history of Classical symptoms of Amlapitta i.e. frequent episodes of Hridkanthadaah (heartburn), Aruchi (loss of appetite), Utklesha (nausea), Tiktaamlaudgar (regurgitation), (flatulence) or Avipaka (dyspepsia/indigestion) symptoms for at least 4 months and on at least 5 of the 7 days prior to screening. Patient fit for Virechana procedure were in inclusion. Individuals were excluded if they had (i) Patients aged below 20 years and above 60 years; (ii) a clinical history or symptom profile suggestive of complicated GERD, other GI diseases (including Barrett's oesophagus, acute peptic ulcer, or indication for Helicobacter pylori eradication therapy) or any severe diseases of other major body systems; (iii) any existing conditions that might compromise their safety or participation in the study like Pregnant/lactating women. This study was approved by Institutional Ethics Committee (IEC and all participants provided written informed consent prior to the initiation of any study related activities. This study was conducted in accordance with the Declaration of Helsinki, the International Conference on Harmonization Good Clinical Practice (ICH GCP) guidelines, and applicable regulatory requirements, and is registered in the Clinical Trials Registry -India (CTRI/2018/03/012546). Treatment allocation and treatment schedule Participants were randomly assigned to receive either Khand Pippali Awaleha or Virechana followed by placebo capsule, based on a lottery randomization. The placebo capsules were composed mainly 250 mg of dry roasted wheat flour. The placebo capsules matched the Omeprazole in appearance and taste. All study personnel and participants were explained about the treatment. allocated. Participants started treatment the day after their randomization visit. In group A, Virechana Karma (Table 1) was given and after Virechana, patients were administrated with placebo for 45 consecutive days: in morning with lukewarm water as Anupana. In group B Khanda Pippali Avaleha was given in the dose of 10 gram/day twice in a day after meal with Journal of Ayurveda and Integrated Medical Sciences 2021;6(1)

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Anshul et al. Randomized parallel group clinical trial in Amlapitta Luke warm water for 60 consecutive days. Study total duration was 60 days followed by a period of 15 days after the completion of trial. Table 1: Method of Drug Administration for Virechana Karma S Procedure 1. DeepanaDrug and Dose Duratio n Ajmodadi Churna 3 gm BD with luke warm 4 days Pachana water Go-ghrita 2. Snehapana 3. Virechana Karma Trivrita Avlaha, Triphla Kwatha 4. Sansarjan Diet as per Shuddhi 3-7days 1 day 3-7 days Completed the study (Figure 1). Relief observed in cardinal symptoms of disease like Daha, Amlodgara, Shula, Chhardi, Avipaka, Aruchi and Utklesha was 79%,79%,74%, 85%, 86%, 85% and 86% respectively in Group A (Table 2). While in Group B relief found was 79%, 81%, 69%, 75%, 67%, 74 % and 93 % respectively (Table 3). Result was statistically highly significant (P < 0.001) in both the groups. Table 2: Effect of therapy on Cardinal symptoms in Group A Valu Dah Amlodgar Shool Chhard Avipak Aruchi Utklesha Karma Study assessments Efficacy assessments were based on on the disease. Mean BT 3.33 AT 0.7143 S.E BT 1.72 AT 0.196 2.619 2.750 1.76 1.75 0.5833 0.46 0.278 0.166 0.1486 0.183 2.167 1.30 3.100 2.705 2.789 0.250 0.487 0.2500 1.500 0.4502 0.1176 0.2164 0.2059 0.4211 0.1636 0.1141 0.080 2.650 2.588 0.1589 2.368 % 79 79 74 185 86 85 86 questionnaire of the symptoms Participants completed the questionnaire before the start of treatment and completed at the end of treatment. The recall period used for questionnaire was 'the last 15 days. The questionnaire is a 14-item self-administered questionnaire designed to assess symptom frequency and severity corresponding to cardinal and associated symptoms of Amalpitta. Responses are scored on a zero-to-five-point scale for cardinal symptoms, with higher scores indicating more severe or frequent symptoms. A validated English and Hindi language version of the questionnaire was used in this study. The primary endpoint was the questionnaire cardinal symptoms of Amalpitta dimension score. Secondary endpoints included the associated symptoms on questionnaire dimension scores. The change in each questionnaire dimension score was calculated as the difference between the baseline and post treatment scores. Changes in questionnaire dimension scores (from baseline to post treatment) were then compared between the Virechana along with placebo groups and Khand Pippali Awaleha. Statistical analysis Wilcoxon signed rank test was used for within group comparison and Independent sample "t" test was used to compare the mean difference between the groups A and B. Observations and Results Participant demographics and baseline characteristics A total of 42 participants, 21 in each group P value <0.001 <0.05 <0.05 <0.05 <0.00 <0.001 <0.001 Table 3: Effect of therapy on Cardinal symptoms in Group B Valu Dah Amlodgar Shool Chhard Avipak Aruchi Utklesha e a a a i a Mean BT 3.150 2.737 2.062 1.714 2.619 3.474 2.619 AT 0.660 0.526 0.588 0.4286 0.857 0.2105 0.2381 S.E BT 0.166 AT 0.1313 2,508 79 81 69 75 0.2142 0.2322 0.2857 0.2334 0.2341 0.1177 0.1929 0.2020 0.1429 0.9640 2,211 1,439 1,286 1,762 3.26 74 0.2009 0.0954 2,381 67 93 <0.001 <0.00 <0.001 <0.05 <0.00 <0.001 <0.001 % P value Relief observed in associated symptoms of disease like Adhmana, Vibandha, Bhrama, Klama, Tandra, Bhaktodwesh, Lalasrava, and Kukshishool was 62%, 91%, 52%, 34%, 80%, 87%, 84% and 72% respectively in Group A (Table 4). While in Group B relief found was 70%,78%,63%, 62%, 70%, 75%, 85% and 69% respectively (Table 5). Result was statistically highly significant (P < 0.001) in both. the groups. Table 4: Effect of therapy on associated symptoms in Group A Val Adhm Viban- Bhra Kla Tan Bhakto- Lala- Kukshi Meal BT 2.650 2.7502.112.66 2.700 n 2.857 2.33 2.2 AT 1.000 0.2501.00 1.76 0.5520 0.3810 0.38 0.6 Journal of Ayurveda and Integrated Medical Sciences 2021;6(1) 3

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Anshul et al. Randomized parallel group clinical trial in Amlapitta S.E BT 0.1957 0.7280 0.2829 0.1436 0.1933 0.1251 2.0 0.3134 Aruchi A 17 97.06 8030 0.302 >0.05 AT 0.2053 0.1230 0.2712 0.1176 0.1983 0.1086 0.0 0.2631 B 19 92.98 13.96 x 1.652 2.508 1.118 0.9048 2.150 2.476 2.14 1.6252 Utklesha A 20 85.41 24.46 0.814 |>0.05 % 62 91 52 34 80 87 184 72 B 21 87.30 26.30 P value <0.001 <0.001 <0.05 <0.001 <0.001 <0.001 <0.001 <0.05 Table 5: Effect of therapy on associated symptoms in Group B Val Adhm Viban- Bhra Kla Tan ue ana dha ma ma dra Mea BT Table 7: Comparison of Percent change in Associated symptoms between Group A & Group B [100*(BT-AT) /BT)] BhaktoLalaKukshi Percent Diff Groups N Mean Std. Deviation $P Value dwesh srava shool Adhmana A 20 63.33 34.13 0.417 >0.05 SBT 3.143 2.8102.28 2.60 2.611 3.316 2.063 2.20 B 21 70.79 23.28 n 0.952 0.619 0.85 1.05 0.777 0.312 B 21 82.85 24.43 0 Bhrama A 17 60.29 43.35 0.883 >0.05 AT 7 0.1756 0.188 0.17 0.16 0.1906 3 17 0.1754 0.1197 0.21 38 B 20 31.66 30.15 Tandra A 20 81.66 29.69 0.192 >0.05 x 2.190 2.190 1.42 1.63 1.8337 2.474 1.753 9 2 1.60 0 IB 18 67.60 35.45 Bhaktodves A 21 87.69 16.16 0.043 <0.05 1% 70 78 63 62 70 75 85 69 B 19 72.98 27.41 P value <0.001 10.00-20.0 20.0 <0.001 <0.001 <0.001 ±0.0 Lalasrava A 20 87.50 22.86 0.992 >0.05 Independent samples t test was used to compare the mean difference between Group A and Group B. Result indicated that in cardinal symptoms mean percent difference between two groups was not statistically significant except symptoms Daha and Avipaka where relief was found more in Group A than Group B and statistically difference was significant (p<0.05) for both the symptoms. Other cardinal symptoms showed similar improvement in both the groups. (Table 6) Where in associated symptoms mean percent difference was statistically significant (p<0.05) only in two symptoms that is Klama, Bhaktodwesa. All the other associated symptoms showed similar improvement in both the groups. (Table 7) Table 6: Comparison of Percent change in Cardinal symptoms between Group A & Group B [100*(BT-AT) /BT)] Percent Diff Groups n Mean Std. Deviation $P Value B Kukshishul A B 16 87.45 19.72 8 70.73 36.46 15 70.00 38.03 0.960 |>0.05 Overall effect of therapy reveled that, maximum patients were seen with moderate improvement in Group A with a percentage of 76.2% while in Group B it was 71.4%. Marked improvement was observed 4.8% in Group A and 23.8% in Group B. Four (4) patients were seen with mild improvement in Group A with a percentage of 19% and one (1) patient in Group B with percentage of 4.8%. There was no patient in both the groups with no improvement at all. (Table 8) (Figure 2). Table 8: Statistical analysis of overall effect of both groups [100* (BT-AT) /BT)] Relief Group A=21 Group B=21 Tot % al No. of patients % No. of % No. of patients patients Daha A 21 80.23 25.13 0.002 <0.05 Complete Improvement (100%) 0 0 0 lo 00 B 20 80.66 17.11 Amlodgar A 12 80.27 18.55 0.846 |>0.05 Marked Improvement (75% to <100%) 1 4.8 5 23.8 6 14. B 19 78.77 22.10 Shoola A 13 79.48 27.34 0.509 |>0.05 Mod. Improvement (50% 16 to <75%) 76.2 15 71.4 31 73. 8 B 16 71.87 32.75 Chhardi A 2 91.66 16.66 0.361 >0.05 Mild Improvement (25% to <50%) 4 19.0 1 4.8 5 11. wa B 7 71.42 39.33 Unchanged (<25%) 0 0 0 0 00 Total 21 100.00 21 100.00 42 100 Avipaka A 20 85.66 17.16 0.003 <0.05 .0 21 57.93 35.88 Journal of Ayurveda and Integrated Medical Sciences 2021;6(1)

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Anshul et al. Randomized parallel group clinical trial in Amlapitta Relief Percentage are calculated from the average improvement of the all factors Safety No any adverse drug reactions (ADR) were noted or reported. No deaths or significant changes in vital signs were reported in either group during the study. Discussion In Amlapitta, Pitta (Pachaka), Vata (Saman) and Kapha (Kledaka) dosha gets vitiated.[10] Pitta dosha mainly vitiate in terms of its Drava (liquidity) and Amla guna (sourness) which is increased. The involved Dosha decreases the Jatharagni (to below the normal level) i.e., Jatharagnimandya. Improper Agni results in to Vidagadh paka and further Sukta paka of the food. Vitiated Pitta gets mixed with Sukta and causes Pitta Amavisa Sammurchhana[11] resulting in cardinal symptoms of Amlapitta.[12] Acharya explained the management by performing Vamana, Virechan, Anuvasana, Niruha Basti, Raktamoksha, and Shaman drugs, followed by the dietary restrictions for Amlapitta.[13] Thus, to evaluate efficacy of Virechana and KPA in Amlapitta, randomized, interventional clinical trial was planned. Virechana was statistically superior to KPA for all primary end points and KPA was superior in Klama, Bhaktodwesh (secondary endpoints). On the basis of percentage, Virechana Group (group A) provided better results on all chief complains & on associated complains, KPA has provided good results. Study participants were recruited from among attendees of Rishikul hospital across Haridwar and are likely to be representative of the local population of patients with mild to moderate symptomatic Amalpitta. Patients with severe reflux were excluded from this study, and therefore the findings may not be general-able to patients with more severe disease. Due to the inclusion of non severe cases in study, the findings are primarily applicable to patients having acute and mild symptoms of Amalpitta symptoms, whereas individuals with severe or chronic disease more likely to receive this treatment with higher dose of medicine of group B i.e. Khand Pippali Avleha and different Rasayan drugs indicated in Ayurvedic text for Amalpitta followed after Virechana. Although the minimum dose (two tablets four times daily) was used in this Study to maximize compliance, a statistically significantly greater improvement was still observed in the group B. In Khanda Pippali Avaleha all the main ingredients except Pippali, have Madhura Rasa, Madhura Vipaka and Sheeta Veerya which rectify the vitiated Pitta and Vata dosha. Pippali has Deepan, Pachan, Vatakaphah shamaka property [14] which activate the Mandagni and acts on Kledaka Kapha. Shakkar also have properties like chardi Hara (anti emetic) and Vata-pitta pacifying. [15] Aamlaki with Tridodh Hara Guna, helps in expel out the excessive Vidagdha Pitta from the body because of its Mrudu Rechaka Guna. Ethanol extracts of 'Aamlaki' Emblica officinalis carrying anti-secretory, antiulcer, and cyto-protective properties.[16] Goghrita has Tridosha Nashaka and Agnivardhaka property.[17] Shatavri have proven Anti-ulcer and Anti secretory property.[18] Virechana is preferred in Pitta pradhan disorders as a Shodhana. With the Deepan- pacchan Karma increases Jatharagni by doing Ama pachan.[19] Snehan and Swedana karma helps the vitiated doshas to leave the peripheral part of and come in the Kostha. Virechan helps in expelling out the excessive accumulated Pitta and Kapha Dosh.[20] It removes Avarana of Vayu in Kostha and corrects the Agnivaigiunyata.[21] No safety issues were observed with both groups, which showed tolerability. Conclusion Sustained effect with no reoccurrence after one month of Virechana Karma suggest that it can be chosen as main treatment option. Recurrence in some patients of KPA suggest that it may be an add on treatment option for patients with mild to moderate symptoms of Amalpitta. Reference 01. Barling E, Brooks A. It's not your fault: Weight Gain, Obesity & Addictions. Outskirts Press: Denver. 1st edition, 2010. [Crossref] [PubMed][Google Scholar] 02. Mishra SS, Gupta AK, Panja AK, Meena KL. An analytical review of Amlapitta in the purview of changing lifestyle. Ayurpharma Int J Ayurveda Allied Science. 2012 Dec, 29:1(8):172-178. [Crossref] [PubMed][Google Scholar] Journal of Ayurveda and Integrated Medical Sciences 2021;6(1) 5

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