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CTRI Number  CTRI/2024/01/061023 [Registered on: 01/01/2024] Trial Registered Prospectively
Last Modified On: 09/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda
Yoga & Naturopathy 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   a scientific study to see if the management of obesity is possible through people practising a specific set of yoga poses, and drinking warm water. 
Scientific Title of Study   A Randomised Controlled Clinical Trial of Practicing a Set of Yogasana with add-on effect of Ushnambupaan and only Ushnambupaan in the management of Sthaulya. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Rohit Pawar 
Designation  MD Scholar 
Affiliation  Maharashtra University of Health Sciences  
Address  Department of Swasthavritta and Yoga, 2nd Floor, RSMs Tilak Ayurved Mahavidyalaya, 583/2 Rasta Peth, Pune 11

Pune
MAHARASHTRA
411011
India 
Phone  09021470743  
Fax    
Email  rohits25844@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Nileema Shisode 
Designation  Associate Professor 
Affiliation  Maharashtra University of Health Sciences 
Address  Department of Swasthavritta and Yoga RSMs Tilak Ayurved Mahavidyalayha, 583/2 Rastapeth, Pune 11

Pune
MAHARASHTRA
411011
India 
Phone  9422058413  
Fax    
Email  nileema.shisode7@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Nileema Shisode 
Designation  Associate Professor 
Affiliation  Maharashtra University of Health Sciences 
Address  Department of Swasthavritta and Yoga RSMs Tilak Ayurved Mahavidyalayha, 583/2 Rastapeth, Pune 11

Pune
MAHARASHTRA
411011
India 
Phone  9422058413  
Fax    
Email  nileema.shisode7@gmail.com  
 
Source of Monetary or Material Support  
Seth Tarachand Ramnath Charitable Ayurvedic Hospital. Vednath S Marg, Rasta Peth, Pune, Maharashtra 411011 
 
Primary Sponsor  
Name  Dr Rohit Anil Pawar 
Address  Department of Swasthavritta and Yoga RSMs Tilak Ayurveda Mahavidyalaya, 583/2 Rastapeth Pune 11  
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
Private clinic  Shiv MultiSpecaility Hospital, Satpur Nashik 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Nileema Shisode  Seth Tarachand Ramnath Charitable Ayurvedic Hospital.  Room no. 27, Department of Swasthyarakshan and Diabetes, 3rd Floor, Seth Tarachand Ramnath Charitable Ayurvedic Hospital. Vednath S Marg, Rasta Peth, Pune, Maharashtra 411011
Pune
MAHARASHTRA 
9422058413

nileema.shisode7@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Tilak Ayurved Mahavidyalaya, Rastapeth, Pune Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:E668||Other obesity. Ayurveda Condition: MEDOROGAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmLifestyle--Dinacarya: Ushnambupaana throughout the day, whenever there is an urge to drink water, participants must drink warm water, Ritucarya: , Acara Rasayana:, Other:, Pathya/Apathya:, Pathya:, Apathya:
2Intervention ArmLifestyle--Dinacarya: Vyayama - Practicing a set of Yogaasana, Ritucarya: , Acara Rasayana:, Other:drinking warm water to assess the add-on effect., Pathya/Apathya:no, Pathya:, Apathya:
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patients of age 20 to 65 years with Sthaulya irrespective of sex
ii. Patient BMI ranging from 24.9 to 34.9 Kg/M2 (Overweight & Class I) irrespective of Diabetes Mellitus & Hypertension
iii. Patient presenting with “Pratyatmaka Lakshana” of Sthaulya as explained in classics.
 
 
ExclusionCriteria 
Details  i. Patients with hypothyroidism
ii. Pregnant women and post-pregnancy weight gain women
iii. Postmenopausal weight gain
iv. Patient with severe illness viz. Diabetic nephropathy, Chronic cardiac failure, Acute renal failure.
v. Patients with disorders such as Eczema, Psoriasis, Cuts, Burns, wounds
vi. Patients with secondary causes of Sthaulya viz. High cholesterol (Dyslipidaemia), fatty liver diseases, polycystic ovarian syndrome, hypothyroidism, hypercortisolism (Cushing’s disease)
vii. Patients with morbid obesity that is, BMI >34.9 (Class II & III)
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Weight of the Patient   baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, 12 Weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Practicing Yogasana along with Ushnambupaan shows no significant changes in the patients of Sthaulya.   90 days 
 
Target Sample Size   Total Sample Size="32"
Sample Size from India="32" 
Final Enrollment numbers achieved (Total)= "64"
Final Enrollment numbers achieved (India)="64" 
Phase of Trial   N/A 
Date of First Enrollment (India)   31/01/2024 
Date of Study Completion (India) 17/06/2024 
Date of First Enrollment (Global)  31/01/2024 
Date of Study Completion (Global) 17/06/2024 
Estimated Duration of Trial   Years="1"
Months="5"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  

Title

A randomised controlled clinical trial of practicing a set of Yogasana with add on effect of Ushnambupaan and only Ushnambupaan in the management of Sthaulya.

Introduction

Obesity, or Sthaulya, is a significant public health concern worldwide, associated with various comorbidities such as diabetes, hypertension, and cardiovascular diseases. The traditional practice of Yogasana (Yoga postures) combined with Ushnambupaan (the intake of warm water) offers a natural and accessible means of managing obesity. This study aims to assess the effects of these interventions on both subjective and objective parameters in patients with Sthaulya.

Aims and Objectives

The primary objective of the study was to evaluate the efficacy of Yogasana, as outlined in the Ashtanga Yoga Primary Series, in combination with Ushnambupaan in managing obesity. The study sought to assess improvements in both subjective symptoms (such as fatigue and sweating) and objective measures (such as weight, BMI, and waist-to-hip ratio).

Materials and Methodology

The study was a randomized controlled trial conducted over 90 days, with follow-ups every 15 days. It involved 64 patients, randomly divided into two groups

Group A (Intervention Group) received both Yogasana and Ushnambupaan.

Group B (Control Group) received only Ushnambupaan.

The subjective parameters assessed included Dourgandhya (foul body odor), Dourbalya (weakness), Swedabadha (excessive sweating), Kshudhatimatra (excessive hunger), and Pipasatimatra (excessive thirst). The objective parameters included weight, BMI, waist-to-hip ratio, and neck girth. Data were analyzed using the Wilcoxon test, paired t-test, and Friedman test.

Follow-ups

Were conducted through telephonic and personal meetings. 

Observations

Group A demonstrated significant improvements in all subjective symptoms:

Dourgandhya: 75% improvement in Group A vs. 10% in Group B.

Dourbalya: 55% improvement in Group A vs. 15% in Group B.

Swedabadha: 35% improvement in Group A vs. no improvement in Group B.

Kshudhatimatra: 35% improvement in Group A vs. 5% in Group B.

Pipasatimatra: 35% improvement in Group A vs. 5% in Group B.

In terms of objective measures, Group A showed a more significant reduction in weight and BMI compared to Group B, confirming the added value of Yogasana in conjunction with warm water therapy.

Results

The results showed that the combination of Yogasana and Ushnambupaan was highly effective in reducing both subjective symptoms and objective indicators of obesity. Statistical analysis revealed significant differences between Group A and Group B in terms of improvements, with Group A showing superior outcomes across all parameters.

Discussion

The findings suggest that Yogasana enhances metabolic functions, reduces Kapha and Meda (excess fat), and improves overall physical health. The practice of Yogasana, along with warm water therapy, promoted significant improvements in the subjective well-being of patients, particularly in terms of reducing body odour, weakness, and excessive sweating. These results align with traditional Ayurvedic principles that emphasize physical activity and dietary interventions for managing obesity.

Conclusion

The study concludes that incorporating Yogasana with Ushnambupaan is an effective strategy for managing obesity. Patients in Group A experienced significant improvements in both subjective and objective measures, suggesting that this combined approach has potential as a low-cost, accessible treatment for obesity. The findings support the idea that Yogasana, as a physical exercise, can be a key component in therapeutic approaches to obesity.

References

A comprehensive list of references from Ayurvedic literature, modern clinical studies, and research papers on Yogasana, Ushnambupaan, and obesity management will be included in the next section. These references support the discussion and conclusions drawn from the study.

 
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