| 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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E668||Other obesity. Ayurveda Condition: MEDOROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Lifestyle | - | - | 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: | | 2 | Intervention Arm | Lifestyle | - | - | 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. IntroductionObesity,
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 ObjectivesThe
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 MethodologyThe
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. ObservationsGroup
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. ResultsThe
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. DiscussionThe
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. ConclusionThe
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. |