| CTRI Number |
CTRI/2025/10/095980 [Registered on: 13/10/2025] Trial Registered Prospectively |
| Last Modified On: |
10/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [Yoga] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of trikatu churna and surya namaskar in obesity |
|
Scientific Title of Study
|
A comparative study to evaluate the efficacy of suryanamaskar and trikatu churna in sthaulya w.s.r to obesity. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Swati katyayen |
| Designation |
MD SCHOLAR |
| Affiliation |
SRI GANGANAGAR COLLEGE OF AYURVEDIC SCIENCE AND HOSPITAL |
| Address |
P. G. DEPARTMENT OF SWASTHVRITTA AND YOGA SECOND FLOOR SRI GANGANAGAR COLLEGE OF AYURVEDIC SCIENCE AND HOSPITAL, TANTIA UNIVERSITY SRIGANGANAGAR RAJASTHAN
INDIA
Ganganagar
RAJASTHAN
335002
India |
| Phone |
9664089771 |
| Fax |
|
| Email |
swatikatyayan09@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Archna |
| Designation |
Assistant professor |
| Affiliation |
SRI GANGANAGAR COLLEGE OF AYURVEDIC SCIENCE AND HOSPITAL |
| Address |
P. G. DEPARTMENT OF SWASTHVRITTA AND YOGA SECOND FLOOR SRI GANGANAGAR COLLEGE OF AYURVEDIC SCIENCE AND HOSPITAL, TANTIA UNIVERSITY SRIGANGANAGAR RAJASTHAN
INDIA
Ganganagar
RAJASTHAN
335002
India |
| Phone |
7014755171 |
| Fax |
|
| Email |
ayurarchna@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Archna |
| Designation |
Assistant professor |
| Affiliation |
SRI GANGANAGAR COLLEGE OF AYURVEDIC SCIENCE AND HOSPITAL |
| Address |
P. G. DEPARTMENT OF SWASTHVRITTA AND YOGA SECOND FLOOR SRI GANGANAGAR COLLEGE OF AYURVEDIC SCIENCE AND HOSPITAL, TANTIA UNIVERSITY SRIGANGANAGAR RAJASTHAN
INDIA
Ganganagar
RAJASTHAN
335002
India |
| Phone |
7014755171 |
| Fax |
|
| Email |
ayurarchna@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
SRI GANGANAGAR COLLEGE OF AYURVEDIC SCIENCE AND |
| Address |
PG DEPARTMENT OF SWASTHVRITTA AND YOGA SRIGANGANAGAR COLLEGE OF AYURVEDIC SCIENCE AND HOSPITAL |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| SWATI KATYAYEN |
SRIGANGANAGAR COLLEGE OF AYURVEDIC SCIENCE AND HOSPITAL |
ROOM NO 9 OPD OF DEPARTMENT OF SWASTHAVRITTA AND YOGA PG DEPARTMENT OF AYURVEDA SRIGANGANAGAR RAJASTHAN
Ganganagar
RAJASTHAN |
9664089771
swatikatyayan09@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| sri ganganagar college of ayurvedic science and hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Individuals with BMI in between 25 to 40 |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Lifestyle | - | - | Dinacarya: suryanamaskar, Ritucarya: , Acara Rasayana:, Other:, Pathya/Apathya:yes, Pathya:Lukewarm water,Take food according to aharvidhi visheshayatanas, Apathya:fried food,divaswapa | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: TRIKATU CHURNA, Reference: SHARANGDHAR SAMHITA MADHYAM KHAND 6/12-13, Route: Oral, Dosage Form: Churna/ Powder, Dose: 2(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: -Lukewarm water), Additional Information: -take food according to aharvidhi visheshayatanas,apathya:fried food,divaswapa |
|
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Individuals between the age group of 20 to 60 years of either sex of obesity for minimum one month
duration.
-diagnosed and confirmed cases of sthaulya on the basis of clinical examination.
-patients with BMI IN between 25 to 40.
-patients willing to sign the consent form. |
|
| ExclusionCriteria |
| Details |
Patients below 20 years and above 60 years
-Patients suffering from diseases like nephrotic syndrome, hypothyroidism, jaundice, hepatitis,
chronic infections & other diseases.
-Patients having B.M.I. below 25
-Patients having obesity due to secondary reason such as drug induced or hormonal imbalance.
-Patients not willing to sign the consen |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in SIGNS AND SYMPTOMS OF OBESITY |
2 MONTHS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| IMPROVEMENT IN SUBJECTIVE AND OBJECTIVE ASSESSMENT CRITERIA OF OBESITY |
2MONTHS |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
22/10/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Due to increase in Meda and Maansa Dhatu, the buttocks, tummy and breast areas become so thick and hang down that they keep shaking while walking. Organs do not grow properly and they do not have proper enthusiasm to work; such people are called extremely obese. In this modern era of science and technology, man has become more and more physically inactive along with these dietary habits has changed towards unhealthy food like fast foods, cold drinks, liquors, smoking etc. and hence now a days the code and conduct narrated in the ancient texts of Ayurveda have been ignored. By exposing on self to all these factors human beings unknowingly invited number of diseases, out of which obesity is one which disturbs physical, mental as well as social health of individual. Sthaulya is abnormal and excess accumulation of Meda Dhatu. In contemporary medical science it is compared with obesity and it is defined as excess body and visceral fat that poses health risk. |