E-ISSN:2456-3110

Research Article

Gomutra Triphala Vati

Journal of Ayurveda and Integrated Medical Sciences

2023 Volume 8 Number 9 September
Publisherwww.maharshicharaka.in

A randomized controlled clinical study to evaluate the efficacy of Gomutra Triphala Vati in the management of Sthoulya

Bhat P1*, Shetty S2, Kumari N3
DOI:10.21760/jaims.8.9.2

1* Prithvi N Bhat, Final Year Post Graduate Scholar, Department Of Pg Studies In Kayachikitsa, Alva's Ayurveda Medical College, Moodubidire, Karnataka, India.

2 Susheel Shetty, Professor and Head, Department of PG studies in Kayachikitsa, Alva’s Ayurveda Medical College, Moodubidire, Karnataka, India.

3 Nikel Kumari, Assistant Professor, Department of PG studies in Kayachikitsa, Alva’s Ayurveda Medical College, Moodubidire, Karnataka, India.

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 500mg, two tablets, twice daily, after food with Ushna Jala (Warm water) for 45 days, respectively. Assessment was done at baseline i.e.; 0th day, 16th day, 31st day, after treatment on 46th day and after follow up on 61st 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, H1 is rejected and H0 is accepted.

Keywords: Gomutra Triphala Vati, Navaka Guggulu, Sthoulya, Overweight, Class one Obesity

Corresponding Author How to Cite this Article To Browse
Prithvi N Bhat, Final Year Post Graduate Scholar, Department Of Pg Studies In Kayachikitsa, Alva's Ayurveda Medical College, Moodubidire, Karnataka, India.
Email:
Bhat P, Shetty S, Kumari N, A randomized controlled clinical study to evaluate the efficacy of Gomutra Triphala Vati in the management of Sthoulya. J Ayu Int Med Sci. 2023;8(9):7-15.
Available From
https://jaims.in/jaims/article/view/2762

Manuscript Received Review Round 1 Review Round 2 Review Round 3 Accepted
2023-08-28 2023-09-04 2023-09-17 2023-09-20 2023-09-20
Conflict of Interest Funding Ethical Approval Plagiarism X-checker Note
None declared Nil Yes 19.47%

© 2023by Bhat P, Shetty S, Kumari Nand Published by Maharshi Charaka Ayurveda Organization. This is an Open Access article licensed under a Creative Commons Attribution 4.0 International License https://creativecommons.org/licenses/by/4.0/ unported [CC BY 4.0].

Introduction

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 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 /m2 and Class one Obesity is a BMI ranging between 30-34.9 Kg/m2.[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 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.

Aim of the study

To evaluate the therapeutic effect of Gomutra Triphala Vati in the management of Sthoulya. (Overweight and Class one Obesity)

Objectives 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)

Methodology

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
    • Group A - Gomutra Triphala Vati
    • 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/m2 (Over weight)
  • 30 to 34.9 Kg/m2 (Class One Obesity)



Associated with any two of 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
4. Subjects who are ready to give written informed consent.
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

AtikshudhaAtisweda
AtipipasaDourgandhya
AtinidraChala Sphik
AlpashwasaChala Udara
AlpavyayamaChala 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 AGroup B
Study DrugGomutra Triphala VatiNavaka Guggulu
Dose500mg 2 TabletsTwice daily500mg 2 TabletsTwice daily
AnupanaUshna JalaUshna Jala
Route of administrationOralOral
Time of administrationAfter foodAfter food
Duration of treatment45 days45 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 16th day, on 31st day and on 46th day.

Follow Up

Follow up of the patient will be done on 61st 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.

Observations and Results

Table 3: Observation of 60 Patients

CharacteristicsPredominancePercentage
Age41-50 years40%
GenderFemale61.66%
ReligionHindu76.6%
Marital statusMarried86.6%
OccupationHouse wife35%
DietVegetarian55%
PrakritiKapha Vata68.3%
Saara Medo Saara58.3%
Abhyavaharana ShaktiPravara56.6%
Jarana ShaktiMadhyama56.6%
Vyayama ShaktiMadhyama63.3%
WeightOverweight85%
Class I obesity15%

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 criteriaGroupMean ValueRM Anova on Ranks
BTATQ ValueP<0.05
AtikshudhaGroup A0.9330.2674.272Yes
Group B0.9330.3333.695yes
AtipipasaGroup A0.3330.0661.328No
Group B0.06670.0330.231No
AtiswedaGroup A0.50.1672.021No
Group B1.2670.3335.484No
AtinidraGroup A1.30.45.427Yes
Group B1.10.24.907Yes
AlasyaGroup A1.4670.3676.697Yes
Group B1.5670.3337.217Yes
AlpashwasaGroup A0.5670.12.54No
Group B0.2330.06671.386No
Alpa VyayamaGroup A0.7670.1676.12Yes
Group B1.30.33.464Yes
DourgandhyaGroup A0.1670.03330.693No
Group B0.9670.4333.853No
Chala SphikGroup A0.3330.1670.924NO
Group B0.6330.3332.483NO
Chala UdaraGroup A0.5330.22.136NO
Group B0.5330.32.021NO
Chala StanaGroup A0.2670.1330.924No
Group B0.3330.1671.443No

Table 5: Effectiveness of the medicine before and after the trial on Objective Parameters

Assessment criteriaGroupMean ValueRM Anova on Ranks
BTATQ ValueP<0.05
Body weightGroup A75.24773.0210.335Yes
Group B75.4472.5110.508Yes
B.MIGroup A27.99327.13310.277Yes
Group B28.07327.3310.392Yes
Midarm CircumferenceGroup A30.0929.5779.18Yes
Group B30.18329.6139.295Yes
Thigh CircumferenceGroup A45.61745.2177.852Yes
Group B46.6346.1979.007Yes
Waist CircumferenceGroup A104.7104.28.545Yes
Group B99.29898.838.198Yes
Chest CircumferenceGroup A102.813102.5935.081Yes
Group B104.407104.0936.928Yes
Hip CircumferenceGroup A103.017102.8674.561Yes
Group B102.153102.0634.561Yes
Waist - HipRatioGroup A0.9770.9751.443No
Group B0.9760.9742.021No

Table 6: Comparative analysis of the overall effect of the treatments on Subjective and Objective Parameters

Assessment criteriaMedian Value BT-ATMann-Whitney TestRemark
Group AGroup BT ValueP Value
Atikshudha009380.739Non- Significant
Atipipasa00961.50.494Non -Significant
Atisweda007520.116Non- Significant
Atinidra10.50926.50.871Non- Significant
Alasya11.5867.50.487Non-Significant
Alpashwasa00972.50.398Non- Significant
Alpa Vyayama208010.093Non- Significant
Dourgandhya007690.131Non- Significant
Chala Sphik00844.50.299Non- Significant
Chala Udara00925.50.882Non-Significant
Chala Stana00887.50.688Non-Significant
Body weight2.05021006.50.178Non -Significant
BMI0.8000.700988.50.280Non -Significant
Midarm Circumference0.5000.4009540.569Non -Significant
Thigh Circumference0.5000.4009180.965Non -Significant
Waist Circumference0.5000.30010140.145Non -Significant
Chest Circumference0.1500.200863.50.451Non -Significant
Hip Circumference0.20009950.239Non -Significant
Waist – HipRatio008850.661Non- 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 ParametersGroup-AGroup-B 
D16D31AT 46FU61D16D31AT 46FU61 
Atikshudha21.43%53.59%71.38%89.28%14.2%42.87%64.3%78.56% 
Atipipasa19.81%60%79.96%90%0%50%50.07%100% 
 
Atisweda7.8%46.6%66.6%86.66%18.4%52.6%73.7%86.81% 
Atinidra17.9%53.8%69.2%97.4%21.1%51.5%98.2%100% 
Alpashwasa25%56.8%74.98%100%21.3%55.3%78.7%89.3% 
Alpavyayama23.6%29.45%82.36%94.12%14.16%14.16%71.37%85.7% 
Alasya17.47%47.84%78.2%100%28.23%56.38%76.92%92.3% 
Dourgandhya20.3%40.11%80.05%80.05%13.85%41.36%55.22%62.04% 
Chalasphik0%30.03%49.84%30.03%0%21.01%47.39%68.4% 
Chalaudara12.3%49.9%62.4%31.33%0%18.7%43.7%56.28% 
Chalastana12.7%37.45%50.18%50.18%0%19.81%49.8%60% 

Table 8: Percentage wise relief in Objective Parameters

Body weight21.43%53.59%71.38%89.28%14.2%42.87%64.3%78.56%
BMI19.81%60%79.96%90%0%50%50.07%100%
Chest circumference7.8%46.6%66.6%86.66%18.4%52.6%73.7%86.81%
MidarmCircumference17.9%53.8%69.2%97.4%21.1%51.5%98.2%100%
WaistCircumference25%56.8%74.98%100%21.3%55.3%78.7%89.3%
HipCircumference23.6%29.45%82.36%94.12%14.16%14.16%71.37%85.7%
ThighCircumference17.47%47.84%78.2%100%28.23%56.38%76.92%92.3%
Waist -hip ratio20.3%40.11%80.05%80.05%13.85%41.36%55.22%62.04%

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, Medodhatvagnimandya 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
  • Trikatu, Triphala are having Deepana and Pachana Karma.
  • Hence it is Amapachaka and reduces the increased
  • 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

Various studies showed that Navaka Guggulu formulation possess Antihyperlipidemic, Anti-obesity 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(H0) is accepted.

H0 - 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).



Acknowledgments

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. 21st Edition, Page No 11216

5. http://www.who.int/mediacentre/factsheets/fs311/en

6. www.who.int/healthinfo/globalhealthrisks

7. https://en.wikipedia.org/wiki/Epidemiology_of_obesity

8. KV Krishna Das. Textbook of Medicine. 5th 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, 36th chapter, Sthoulya chikitsa,
18th Shloka, pg.310

10. Chakradatta, written by Chakrapanidatta, Edited & Translated by PV Sharma, published by Chaukambha orientalia, Varanasi, 2007, 36th chapter Sthoulya chikitsa, 16th 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, 17th 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 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, N0.5 (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 4S | 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