A randomized controlled clinical study to evaluate the efficacy of Gomutra...

[Full title: A randomized controlled clinical study to evaluate the efficacy of Gomutra Triphala Vati in the management of Sthoulya]

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ORIGINAL ARTICLE September 2023 Journal of Ayurveda and Integrated Medical Sciences | September 2023 | Vol. 8 | Issue 9 7 A randomized controlled clinical study to evaluate the efficacy of Gomutra Triphala Vati in the management of Sthoulya Prithvi N Bhat 1 , Susheel Shetty 2 , Nikel Kumari 3 1 Final Year Post Graduate Scholar, Department of PG Studies in Kayachikitsa, Alva’s Ayurveda Medical College Moodubidire, Karnataka, India. 2 Professor and Head, Department of PG studies in Kayachikitsa, Alva’s Ayurveda Medical College, Moodubidire, Karnataka, India. 3 Assistant Professor, Department of PG studies in Kayachikitsa, Alva’s Ayurveda Medical College, Moodubidire, Karnataka, India . I NTRODUCTION Sthoulya is considered as one of the Santarpanottha Vikara [1] and classified under Kaphaja Nanatmaja Vyadhi [2] Acharya Charaka defines Sthoulya as increase of Medomamsa Dhatu which causes Chala Sphik, Chala Udara and Chala Stana . There will be Ayatha Upachaya and Utsahahaani in the individual. Such persons are Address for correspondence: Dr. Prithvi N Bhat Final Year Post Graduate Scholar, Department of PG Studies in Kayachikitsa, Alva’s Ayurveda Medical College Moodubidire, Karnataka, India. E-mail: prithvigurumane@gmail.com Submission Date: 28/08/2023 Accepted Date: 20/09/2023 Access this article online Quick Response Code Website: www.jaims.in DOI: 10.21760/jaims.8.9.2 called Atisthoola and considered as one among Ashta Nindita Purusha [3] Sthoulya is been co-related to Overweight and Obesity in this study Overweight and Obesity are defined as a state of excess adipose tissue mass that adversely affects health [4] According to WHO, Overweight is a BMI ranging between 25-29.9 Kg /m 2 and Class one Obesity is a BMI ranging between 30-34.9 Kg/m 2 [5] The World Health Report of WHO listed Obesity under top ten risks to the health. Obesity is one of the burning problems globally as it will hamper the different systems in the body [6] According to WHO estimation in 2016 more than 1.9 billion adults are Overweight; of these, over 650 million are Obese. These include 12.6% women and 9.3% men in India. Prevalence of Obesity is more in women when compared to men [7] In contemporary science, there are only limited treatments for Obesity like use of weight loss A B S T R A C T Background: Sthoulya is considered as one of the Kaphaja Nanatmaja Vyadhi . Overweight and Obesity are defined as an abnormal, excessive fat accumulation that may impair health. The aim of the study was to assess the efficacy of the two Ayurvedic formulations, Gomutra Triphala Vati which is one of the unexplored Aushadha yoga explained in Vangasena Samhita, Medorogaadhikaara and Navaka Guggulu explained in Chakradatta, Sthoulya Chikitsa in the management of Sthoulya . (Overweight and Class One Obesity). Materials and Methods: 60 patients fulfilling the Diagnostic and Inclusion criteria were selected for a Single Blind Comparative study. They were randomly allocated into 2 equal groups A & B. Group A and Group B subjects received Gomutra Triphala Vati and Navaka Guggulu in a dosage of 500 mg, two tablets, twice daily, after food with Ushna Jala (Warm water) for 45 days, respectively. Assessment was done at baseline i.e.; 0 th day, 16 th day, 31 st day, after treatment on 46 th day and after follow up on 61 st day. Results: While comparing both the drugs clinically, Gomutra Triphala Vati and Navaka Guggulu showed effective results in Sthoulya. On statistical comparison within the groups, both the groups showed significant effect (P<0.05) in Atinidra, Alpavyayama, Alasya , Body weight, BMI, Circumferences of Midarm, Waist, Chest, Hip and Thigh. Conclusion: On statistical comparison between the two groups there is no significant difference in the effect of both Gomutra Triphala Vati and Navaka Guggulu. Thus, H 1 is rejected and H 0 is accepted. Key words: Gomutra Triphala Vati, Navaka Guggulu, Sthoulya, Overweight, Class one Obesity.

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Prithvi N Bhat et al. Efficacy of Gomutra Triphala Vati in the management of Sthoulya ISSN: 2456-3110 ORIGINAL ARTICLE September 2023 Journal of Ayurveda and Integrated Medical Sciences | September 2023 | Vol. 8 | Issue 9 8 medications and Bariatric surgery. But these medications have got multiple contraindications and side effects [8] In the Chikitsa of Sthoulya, various texts of Ayurveda have given wide range of options which includes many of Aushadha yogas like Navaka Guggulu , [9] Amritadya Guggulu, [10] Loharishta [11] etc. In order to explore new formulation by taking reference as mentioned in our Classics, Gomutra Triphala Vati [12] is one of the unexplored Aushadha Yoga explained in Vangasena Samhita Medorogaadhikaara. The ingredients include Gomutra and Triphala Choorna . Gomutra is Teekshna, Laghu, Ushna, Kapha-Vata Shamaka , being Kshareeya it has Medonaashaka property also [13] Triphala is Kapha-Pitta Shamaka, Agnideepaka, Ruchya [14] In the present study, for the preparation of Gomutra Triphala Vati, freshly collected Gomutra from Indigenous Cow Breed Malnad Gidda is being used keeping in mind the Medicinal Values [15] Hence, in this study an attempt is been done to evaluate the efficacy of Gomuta Triphala Vati in comparison with Navaka Guggulu which is taken as a Standard Drug in the management of Sthoulya. A IM OF THE STUDY To evaluate the therapeutic effect of Gomutra Triphala Vati in the management of Sthoulya. (Overweight and Class one Obesity) O BJECTIVES OF THE STUDY 1 To evaluate the therapeutic effect of Navaka Guggulu in the management of Sthoulya as standard drug . (Overweight and Class one Obesity) 2 To compare the therapeutic effect of Gomutra Triphala Vati and Navaka Guggulu in the management of Sthoulya. (Overweight and Class one Obesity) M ETHODOLOGY Source of sample: A minimum of 60 patients attending the OPD and IPD of Alva’s Ayurveda Hospital, Moodubidire, and nearby clinics who were diagnosed as Sthoulya (Overweight and Class One Obesity) and fulfilling the inclusion criteria were selected. Data was collected based on a detailed case proforma designed for the study. ▪ Study design - Randomized Controlled Clinical Study ▪ Blinding - Single blind ▪ Allocation - Random allocation ▪ Method of sampling - Lottery method ▪ Groups - 2 groups o Group A - Gomutra Triphala Vati o Group B - Navaka Guggulu ▪ Sample size - 30 patients in each group ▪ Total sample size - 60 patients Diagnostic criteria Patients having BMI ranging from ▪ 25 to 29.9 Kg/m 2 (Over weight) ▪ 30 to 34.9 Kg/m 2 (Class One Obesity) Associated with any two of the below mentioned features Atikshudha (Excessive Hunger) Atisweda (Excessive Sweating) Atipipasa (Excessive Thirst) Dourgandhaya (Bad Odour) Atinidra (Excessive Sleep) Chala Sphik Alpashwasa (Difficulty in breathing) Chala Udara Alpavyayama (Reduced Activities) Chala Stana Alasya (Lethargy) Inclusion criteria 1 Subjects of both genders. 2 Subjects from age group 18 to 60 years. 3 Subjects having BMI between 25-34.9 Kg/m 2 4 Subjects who are ready to give written informed consent.

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Prithvi N Bhat et al. Efficacy of Gomutra Triphala Vati in the management of Sthoulya ISSN: 2456-3110 ORIGINAL ARTICLE September 2023 Journal of Ayurveda and Integrated Medical Sciences | September 2023 | Vol. 8 | Issue 9 9 5 Subjects fulfilling the diagnostic criteria. Exclusion criteria 1 Subjects who are known case of Diabetes Mellitus, Hypertension, any other systemic diseases. 2 Obese patients with known endocrine dysfunctions. 3 Pregnant women and lactating mothers. Subjective parameters Table 1: Subjective parameters Atikshudha Atisweda Atipipasa Dourgandhya Atinidra Chala Sphik Alpashwasa Chala Udara Alpavyayama Chala Stana Alasya Objective parameters ▪ Body Weight ▪ BMI ▪ Midarm Circumference ▪ Thigh Circumference ▪ Chest Circumference ▪ Waist Circumference ▪ Hip Circumference ▪ Waist Hip ratio Intervention The patients fulfilling the criteria for inclusion are randomly assigned into 2 groups, each comprising of 30 patients. Table 2: Intervention Group A Group B Study Drug Gomutra Triphala Vati Navaka Guggulu Dose 500 mg 2 Tablets Twice daily 500 mg 2 Tablets Twice daily Anupana Ushna Jala Ushna Jala Route of administration Oral Oral Time of administration After food After food Duration of treatment 45 days 45 days Ingredients of formulations Gomutra Triphala Vati : Gomutra, Amalaki, Hareetaki, Vibheetaki. Navaka Guggulu: Shunti, Maricha, Pippali, Amalaki, Hareetaki, Vibheetaki, Musta, Vidanga, Chitrakamoola and Shuddha Guggulu. Observation Period The patients will be assessed clinically before treatment on day 0 and during treatment, on 16 th day, on 31 st day and on 46 th day. Follow Up Follow up of the patient will be done on 61 st day, after the intervention period. Total Study Duration Total study duration including follow up will be 60 days. Investigations Routine Blood Investigations, Lipid profile, Thyroid function test, USG of Abdomen and Pelvis and any other relevant investigations if necessary. O BSERVATIONS AND R ESULTS Table 3: Observation of 60 Patients Characteristics Predominance Percentage Age 41-50 years 40% Gender Female 61.66% Religion Hindu 76.6%

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Prithvi N Bhat et al. Efficacy of Gomutra Triphala Vati in the management of Sthoulya ISSN: 2456-3110 ORIGINAL ARTICLE September 2023 Journal of Ayurveda and Integrated Medical Sciences | September 2023 | Vol. 8 | Issue 9 10 Marital status Married 86.6% Occupation House wife 35% Diet Vegetarian 55% Prakriti Kapha Vata 68.3% Saara Medo Saara 58.3% Abhyavaharana Shakti Pravara 56.6% Jarana Shakti Madhyama 56.6% Vyayama Shakti Madhyama 63.3% Weight Overweight 85% Class I obesity 15% Statistics Statistical tests applied Descriptive Statistics was applied to each parameter first. RM Anova on Ranks and One way RM Anova was performed to prove the effectiveness of the medicine before and after trial and all pair wise Multiple comparison within the group. Mann-Whitney Rank Sum Test and Unpaired t-Test was performed for comparative analysis of the overall effect of the treatments in between the groups. The summarized form of Statistical Analysis is presented below. Table 4: Effectiveness of the medicine before and after the trial on Subjective Parameters Assessment criteria Group Mean Value RM Anova on Ranks BT AT Q Value P<0.05 Atikshudha Group A 0.93 3 0.267 4.272 Yes Group B 0.93 3 0.333 3.695 yes Atipipasa Group A 0.33 3 0.066 1.328 No Group B 0.06 67 0.033 0.231 No Atisweda Group A 0.5 0.167 2.021 No Group B 1.26 7 0.333 5.484 No Atinidra Group A 1.3 0.4 5.427 Yes Group B 1.1 0.2 4.907 Yes Alasya Group A 1.46 7 0.367 6.697 Yes Group B 1.56 7 0.333 7.217 Yes Alpashwasa Group A 0.56 7 0.1 2.54 No Group B 0.23 3 0.0667 1.386 No Alpa Vyayama Group A 0.76 7 0.167 6.12 Yes Group B 1.3 0.3 3.464 Yes Dourgandhy a Group A 0.16 7 0.0333 0.693 No Group B 0.96 7 0.433 3.853 No Chala Sphik Group A 0.33 3 0.167 0.924 NO Group B 0.63 3 0.333 2.483 NO Chala Udara Group A 0.53 3 0.2 2.136 NO Group B 0.53 3 0.3 2.021 NO Chala Stana Group A 0.26 7 0.133 0.924 No

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Prithvi N Bhat et al. Efficacy of Gomutra Triphala Vati in the management of Sthoulya ISSN: 2456-3110 ORIGINAL ARTICLE September 2023 Journal of Ayurveda and Integrated Medical Sciences | September 2023 | Vol. 8 | Issue 9 11 Group B 0.33 3 0.167 1.443 No Table 5: Effectiveness of the medicine before and after the trial on Objective Parameters Assessment criteria Grou p Mean Value RM Anova on Ranks BT AT Q Value P<0.0 5 Body weight Grou p A 75.247 73.02 10.33 5 Yes Grou p B 75.44 72.51 10.50 8 Yes B.MI Grou p A 27.993 27.133 10.27 7 Yes Grou p B 28.073 27.33 10.39 2 Yes Midarm Circumferenc e Grou p A 30.09 29.577 9.18 Yes Grou p B 30.183 29.613 9.295 Yes Thigh Circumferenc e Grou p A 45.617 45.217 7.852 Yes Grou p B 46.63 46.197 9.007 Yes Waist Circumferenc e Grou p A 104.7 104.2 8.545 Yes Grou p B 99.298 98.83 8.198 Yes Chest Circumferenc e Grou p A 102.81 3 102.59 3 5.081 Yes Grou p B 104.40 7 104.09 3 6.928 Yes Hip Circumferenc e Grou p A 103.01 7 102.86 7 4.561 Yes Grou p B 102.15 3 102.06 3 4.561 Yes Waist - Hip Ratio Grou p A 0.977 0.975 1.443 No Grou p B 0.976 0.974 2.021 No Table 6: Comparative analysis of the overall effect of the treatments on Subjective and Objective Parameters Assessment criteria Median Value BT-AT Mann- Whitney Test Remark Group A Group B T Valu e P Valu e Atikshudha 0 0 938 0.739 Non- Significant Atipipasa 0 0 961.5 0.494 Non - Significant Atisweda 0 0 752 0.116 Non- Significant Atinidra 1 0.50 926.5 0.871 Non- Significant Alasya 1 1.5 867.5 0.487 Non- Significant Alpashwasa 0 0 972.5 0.398 Non- Significant Alpa Vyayama 2 0 801 0.093 Non- Significant Dourgandhy a 0 0 769 0.131 Non- Significant Chala Sphik 0 0 844.5 0.299 Non- Significant Chala Udara 0 0 925.5 0.882 Non- Significant Chala Stana 0 0 887.5 0.688 Non- Significant Body weight 2.050 2 1006. 5 0.178 Non - Significant

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Prithvi N Bhat et al. Efficacy of Gomutra Triphala Vati in the management of Sthoulya ISSN: 2456-3110 ORIGINAL ARTICLE September 2023 Journal of Ayurveda and Integrated Medical Sciences | September 2023 | Vol. 8 | Issue 9 12 BMI 0.800 0.700 988.5 0.280 Non - Significant Midarm Circumferen ce 0.500 0.400 954 0.569 Non - Significant Thigh Circumferen ce 0.500 0.400 918 0.965 Non - Significant Waist Circumferen ce 0.500 0.300 1014 0.145 Non - Significant Chest Circumferen ce 0.150 0.200 863.5 0.451 Non - Significant Hip Circumferen ce 0.200 0 995 0.239 Non - Significant Waist – Hip Ratio 0 0 885 0.661 Non- Significant Effect of Therapy 60 patients of Sthoulya were randomly divided into two groups : Group A and Group B . The effects on Subjective Parameters are analyzed here, percentage wise relief compared here with respect to BT at all time points of Observation. Table 7: Percentage wise relief in Subjective Parameters Subjective Parameter s Group-A Group-B D 16 D 31 AT 46 FU 61 D 1 6 D 3 1 AT 46 FU 61 Atikshudha 21.4 3% 53.5 9% 71.3 8% 89. 28 % 14. 2% 42 .8 7 % 64.3 % 78. 56 % Atipipasa 19.8 1% 60% 79.9 6% 90 % 0% 50 % 50.0 7% 10 0% Atisweda 7.8% 46.6 % 66.6 % 86. 66 % 18. 4% 52 .6 % 73.7 % 86. 81 % Atinidra 17.9 % 53.8 % 69.2 % 97. 4% 21. 1% 51 .5 % 98.2 % 10 0% Alpashwas a 25% 56.8 % 74.9 8% 100 % 21. 3% 55 .3 % 78.7 % 89. 3% Alpavyaya ma 23.6 % 29.4 5% 82.3 6% 94. 12 % 14. 16 % 14 .1 6 % 71.3 7% 85. 7% Alasya 17.4 7% 47.8 4% 78.2 % 100 % 28. 23 % 56 .3 8 % 76.9 2% 92. 3% Dourgandh ya 20.3 % 40.1 1% 80.0 5% 80. 05 % 13. 85 % 41 .3 6 % 55.2 2% 62. 04 % Chalasphik 0% 30.0 3% 49.8 4% 30. 03 % 0% 21 .0 1 % 47.3 9% 68. 4% Chalaudar a 12.3 % 49.9 % 62.4 % 31. 33 % 0% 18 .7 % 43.7 % 56. 28 % Chalastana 12.7 % 37.4 5% 50.1 8% 50. 18 % 0% 19 .8 1 % 49.8 % 60 % Table 8: Percentage wise relief in Objective Parameters Body weight 21.4 3% 53.5 9% 71.3 8% 89.2 8% 14.2 % 42.8 7% 64.3 % 78.5 6% BMI 19.8 1% 60% 79.9 6% 90% 0% 50% 50.0 7% 100 % Chest circumfe rence 7.8 % 46.6 % 66.6 % 86.6 6% 18.4 % 52.6 % 73.7 % 86.8 1% Midarm Circumf erence 17.9 % 53.8 % 69.2 % 97.4 % 21.1 % 51.5 % 98.2 % 100 % Waist Circumf erence 25% 56.8 % 74.9 8% 100 % 21.3 % 55.3 % 78.7 % 89.3 %

[Find the meaning and references behind the names: Mode, Dosha, Guna, Level, Karma, Meda, Sara, Active, Shoshana, Adha, Virtue, Rasa, Ama, Sneha, Agni, Sanga, Due, Roga, General, Katu, Medas, Shown]

Prithvi N Bhat et al. Efficacy of Gomutra Triphala Vati in the management of Sthoulya ISSN: 2456-3110 ORIGINAL ARTICLE September 2023 Journal of Ayurveda and Integrated Medical Sciences | September 2023 | Vol. 8 | Issue 9 13 Hip Circumf erence 23.6 % 29.4 5% 82.3 6% 94.1 2% 14.1 6% 14.1 6% 71.3 7% 85.7 % Thigh Circumf erence 17.4 7% 47.8 4% 78.2 % 100 % 28.2 3% 56.3 8% 76.9 2% 92.3 % Waist - hip ratio 20.3 % 40.1 1% 80.0 5% 80.0 5% 13.8 5% 41.3 6% 55.2 2% 62.0 4% DISCUSSION A total of Eleven Subjective Parameters were taken for the study. Most of the patients who complained of subjective Lakshana are responded well in general. Some of the parameters like Chalatva of Sphik , Udara, Stana, Atisweda, Dourgandhya, Atipipasa were responded mildly as the patients were mildly affected by these symptoms and in this study after Randomization, majority of them were Overweight who had 2-3 Subjective Symptoms, but those who were of Class One Obesity had more Subjective Symptoms. The Aoushadha Yogas are having Meda Vilayana and Shoshana , Amapachana properties. The vitiated Meda which gets deposited in Sphik, Stana, Udara, Urdhwa and Adha Shakha can be easily reduced by this treatment thus acting on reduction of Body weight, BMI and Circumferences. Discussion on mode of action of Gomutra Triphala Vati In the Samprapti of Sthoulya, there is Kaphavriddhi , Medodhatvagnimandy a and vitiated Vata due to Avarana. Gomutra due to its Laghu, Ushna, Teekshna Guna and Ushna Veerya does the Shoshana of Prithvi and Jala Mahabhuta Pradhana Medo Dhatu . Triphala has the action of Deepana, Ruchya , Sara Guna and Tridosha Shamaka. Gomutra and Triphala both have shown Anti-obesity action in various studies individually [16] Probable action on Dosha Sthoulya is a Kapha Vataja Vyadhi . The Gomutra Triphala Vati mainly acts on Kapha-Vata by virtue of its Ushna Veerya . Gomutra Triphala Vati is found to be effective Kapha- Vatahara Aoushadha Yoga which is targeted in the Samprapti Vightana of Sthoulya Roga . Probable action on Dooshya There is Meda and Mamsa Vriddhi in Sthoulya Roga and also there is production of Ama Rasa . The Gomutra Triphala Vati breaks the Srotosanga. Hence the active principles can reach to the cellular level. As Gomutra Triphala Vati is having Tikta, Katu and Kashaya Rasa , they cause Shoshana, Lekhana , and Amahara . Due to this Malaroopi Kapha is removed, excessive Medas is scraped away and Ama is removed from the body. Probable action on Agni Gomutra and Triphala both are having Deepana and Pachana Gunas . Deepana has the action to reduce the Mandagni at Kostha and also correcting the Dhatvagnimandya at the level of Medodhatu which has become Mandatva by the Avarana of Ama . This Amapachana is achieved and Medodhatvagni Deepana is simultaneously achieved by the use of Gomutra Triphala Vati. Probable action on Srotas Due to Laghu, Teekshna, Rooksha Guna of the drugs in this Aoushadha, the Gomutra Triphala Vati breaks the Sanga in Medavaha Srotas. So, the Uttarottara Dhatu are nourished and the process of Medo Vriddhi is stopped. Hence accumulation of deranged Medas is inhibited by this Aoushadha. Discussion on mode of action of Navaka Guggulu ▪ Due to Katu Rasa, [17] it has Sneha, Meda and Kleda Upashoshana property ▪ Trikatu, Triphala are having Deepana and Pachana Karma . ▪ Hence it is Amapachaka and reduces the increased Kleda. ▪ Due to Laghu, Rooksha , Teekshna Guna and Ushna Veerya it improves Jataragni and Dhatwagni and Kapha Vatahara in nature. ▪ Katu Vipaka reduces the increased Medo Dhatu and have Sroto Vishodhana action.

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Prithvi N Bhat et al. Efficacy of Gomutra Triphala Vati in the management of Sthoulya ISSN: 2456-3110 ORIGINAL ARTICLE September 2023 Journal of Ayurveda and Integrated Medical Sciences | September 2023 | Vol. 8 | Issue 9 14 ▪ Various studies showed that Navaka Guggulu formulation possess Antihyperlipidemic, Antiobesity activities [18] and beneficial in weight reduction. CONCLUSION While comparing both the drugs clinically, Gomutra Triphala Vati and Navaka Guggulu showed effective results in Sthoulya. On statistical comparison within the groups, both the groups showed significant effect (p<0.05) in Atinidra, Alpavyayama, Alasya , Body weight, BMI, Circumferences of Midarm, Waist, Chest, Hip and Thigh. After treatment there was significant effect on all the parameters except Atipipasa, Atisweda, Dourgandhya, Chala Sphik, Udara, Stana and Waist hip ratio, where statistically insignificant result was seen. The effect of the drugs were maintained even after the treatment till the period of follow-up. On comparing between two groups, there was no statistical significant difference in the effect of treatment with p >0.05. Hence null hypothesis(H 0 ) is accepted. H 0 - There is no Statistically significant difference in the efficacy of Gomutra Triphala Vati and Navaka Guggulu in the management of Sthoulya. (Overweight and Class one Obesity). A CKNOWLEDGMENTS I would like to express my gratitude to my institution and hospital who gave me the possibility to complete this project. Also, I take this opportunity to express my gratitude to my Guide and Co-guide for their valuable guidance . REFERENCES 1 Acharya Agnivesha. Charaka Samhita, with Ayurvedadipika, commentary by Chakrapanidutta, Sutrasthana, Chapter name: Santarpaniyam adhyayam, edition 2011, Chaukambha Surabharati Prakashan, Varanasi, Pp.395. 2 Acharya Agnivesha. Charaka Samhita with Ayurveda Deepika commentary of Chakrapani Datta edited by Vaidya Jadavji Trikamji Acharya, published by Chaukhamba Orientalia Varanasi, Reprint 2011. Sutra Sthana 13/44 Pp: 84 3 Acharya Agnivesha. Charaka Samhita, with Ayurvedadipika, commentary by Chakrapanidutta, Sutrasthana, Chapter name; Ashta ninditiya adhyayam, edition 2011, Chaukambha Surabharati Prakashan, Varanasi, Pp.374. 4 Harrison’s Principle of Internal Medicine. edited by Dennis.L.Kasper, Eugene Braunwall, Antony’s Fauci. 21 st Edition, Page No 11216 5 http://www.who.int/mediacentre/factsheets/fs 311/en 6 www.who.int/healthinfo/globalhealthrisks 7 https://en.wikipedia.org/wiki/Epidemiology_of_obesit y 8 KV Krishna Das. Textbook of Medicine. 5 th edition, Jaypee Brothers medical Publishers, 2008, obesity management, Pg.168 9 Chakradatta, written by Chakrapanidatta, Edited & Translated by PV Sharma, published by Chaukambha orientalia, Varanasi, 2007, 36 th chapter, Sthoulya chikitsa, 18 th Shloka, pg.310 10 Chakradatta, written by Chakrapanidatta, Edited & Translated by PV Sharma, published by Chaukambha orientalia, Varanasi, 2007, 36 th chapter Sthoulya chikitsa , 16 th Shloka, pg.310 11 Bhavamisra. Bhavaprakasha with Vidyodini commentary of Bhishakgrantasri brahmasri Sankara misra sastri edited by Sri Hariharaprasada pandeyena by Chaukhambha Krishnadas Acadamy of Varanasi, Reprint 2009, Sthoulya Chikitsa, Vol 2, pg, 405. 12 Vangasena Samhita, written by Acharya Vangasena, commentary by Kaviraja Shri Shaligramji Vaidhya, printed by Khemaraj Shrikrishnadas; published by Shri Venkateshwar press, 2003, Medorogadhikara, 17 th Shloka , Pp. 496 13 Divodasa Dhanvantari, Sushruta Samhita, elaborated by Sushruta with Nibandha Samgraha commentary by Dalhana and Nyayachandrika Panjika by Gayadasa edited by ‘Vaidhya Jadavji Trikamji Aacharya’ and ‘Narayan Ram Aacharya’, published by Chaukhambha Orientalia, Varanasi, Reprint 2014, Sutra Sthana 46/220 Pp.213 14 Bhavamisra, Bhavaprakasha with Vidyodini commentary of Bhishakgrantasri brahmasri Sankara misra sastri edited by Sri Hariharaprasada pandeyena by

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Prithvi N Bhat et al. Efficacy of Gomutra Triphala Vati in the management of Sthoulya ISSN: 2456-3110 ORIGINAL ARTICLE September 2023 Journal of Ayurveda and Integrated Medical Sciences | September 2023 | Vol. 8 | Issue 9 15 Chaukhambha Krishnadas Acadamy of Varanasi, Reprint 2009, Hareetakyadi Varga, Shloka 42-43 15 Management and Health Care Practices of Malnad Gidda Cattle in Malnad Region of India: B. V. Parameshwara Pratapa Simha et al, International journal Of Current Microbiology and Applied Sciences, ISSN: 2319-7706 vol.9, N 0.5 (2020) 16 Sanjay Sharma, Ketan Hatware. Antiobesity Potential of Fresh Cow Urine and its Distillate - A Biomedicine for Tomorrow. Indian Journal of Pharmaceutical Education and Research, Vol 51, Issue 4 S | Oct-Dec (Suppl), 2017 17 D.S. Lucas. Dravyaguna Vijnana, Study of Dravya Materia medica, Chowkamba Orientalia, Varanasi, Reprint 2019, Pp. 35 18 Evaluation of Anti-Obesity Potential of Commiphora Mukul the Indian Bdellium Plant - Devireddy Ashok Reddy, Mahaveer Singh Annals of R.S.C.B., ISSN:1583- 6258, Vol. 25, Issue 4, 2021, Pages. 13802 – 13810 ******************************* How to cite this article: Prithvi N Bhat, Susheel Shetty, Nikel Kumari. A randomized controlled clinical study to evaluate the efficacy of Gomutra Triphala Vati in the management of Sthoulya. J Ayurveda Integr Med Sci 2023;09:07-15. http://dx.doi.org/10.21760/jaims.8.9.2 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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