| CTRI Number |
CTRI/2025/02/080443 [Registered on: 12/02/2025] Trial Registered Prospectively |
| Last Modified On: |
25/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
How Moringa Tea Affects Obesity With or Without SURYANAMASKAR |
|
Scientific Title of Study
|
A Comparative evaluation of SHIGRU Tea with or without SURYANAMASKAR in the management of STHAULYA W.S.R. to obesity |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
HARSHA VERMA |
| Designation |
MD Scholar,Department Of Swasthavritta Evum Yoga |
| Affiliation |
Shri NPA Govt. Ayurved College Raipur (C.G.) |
| Address |
Department Of Swasthavritta Evum Yoga,Shri NPA Govt. Ayurved College Raipur (C.G.)
Raipur
CHHATTISGARH
492010
India
Raipur
CHHATTISGARH
492010
India |
| Phone |
9179627834 |
| Fax |
|
| Email |
vermaharsha1997@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sasmita Tripathy |
| Designation |
Reader, Department Of Swasthavritta Evum Yoga |
| Affiliation |
Shri NPA Govt. Ayurved College Raipur (C.G.) |
| Address |
Department Of Swasthavritta Evum Yoga, Shri NPA Govt. Ayurved College Raipur (C.G.)
Raipur
CHHATTISGARH
492010
India
Raipur
CHHATTISGARH
492010
India |
| Phone |
8763650383 |
| Fax |
|
| Email |
sasmita1980@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anita Sharma |
| Designation |
Proff HOD, Department Of Swasthavritta Evum Yoga |
| Affiliation |
Shri NPA Govt. Ayurved College Raipur (C.G.) |
| Address |
Department Of Swasthavritta Evum Yoga,Shri NPA Govt. Ayurved College Raipur (C.G.)
Raipur
CHHATTISGARH
492010
India
Raipur
CHHATTISGARH
492010
India |
| Phone |
9827115211 |
| Fax |
|
| Email |
ansharma260@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri NPA Govt. Ayurved College Raipur (C.G.) |
|
|
Primary Sponsor
|
| Name |
Department Of Swasthavritta Evum Yoga |
| Address |
Department Of Swasthavritta Evum Yoga, Shri NPA Govt. Ayurved College Raipur (C.G.) |
| Type of Sponsor |
Other [Govt. Ayurvedic College Raipur (C.G.)] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Department Of Swasthavritta Evum Yoga |
Department Of Swasthavritta Evum Yoga,Shri NPA Govt. Ayurved College Raipur (C.G.) |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| HARSHA VERMA |
Shri NPA Govt. Ayurved College and Hospital Raipur (C.G.) |
Dept. Of Swasthavritta Evum Yoga
OPD NO.6 AND YOGA OPD
Raipur
CHHATTISGARH |
9179627834
vermaharsha1997@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| OFFICE OF THE PRINCIPAL,SHRI NARAYAN PRASAD AWASTHI GOVT. AYURVED COLLEGE ,RAIPUR (CHHATTISGARH) 492010 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
a person with BMI range between 25-40 will be include in this trial. |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | SURYANAMASKAR | (Procedure Reference: ABDM, Procedure details: 3 Rounds at start than as per capacity round will be increased.)
| | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: SHIGRU , Reference: KAIDEV NIGHANTU, Route: Oral, Dosage Form: Phanta, Dose: 32(ml), Frequency: tds, Bhaishajya Kal: Abhakta, Duration: 15 Days, anupAna/sahapAna: No, Additional Information: With or without SURYANAMASKAR |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient age between 18 to 60year.
2. Selection of patient irrespective of race, religion, sex, socio economic status, marital
status.
3. The patient with clinical sign and symptoms of Sthaulya described in Ayurveda.
4. BMI in between 25 to 40.7
5. Patient having symptoms described in Ayurveda and modern literature.
6. Who is willing to give consent. |
|
| ExclusionCriteria |
| Details |
1. Patient age below 18 and above 60year.
2. The patient who is unable to perform Suryanamaskar.
3. Patient with endocrinal disorder, high cholesterol and other systemic diseases.
4. Patient with long term steroid treatment.
5. Who is not willing to give consent. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| the combine Efficacy of SHIGRU tea and SURYANAMASKAR in obesity will recorded by this trial. |
6 month to 1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| individual effect of SHIGRU tea in obesity |
6 month to 1 year |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
24/02/2025 |
| 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="1"
Months="0"
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
|
Sthaulya commonly known as obesity is the 5th leading risk factor of death worldwide. Obesity is a condition characterized by an excessive accumulation of body fat that poses a risk to health. It’s a multifactorial condition influenced by genetic, environmental, and behavioural factors. In Ayurveda, Sthaulya is understood as an imbalance in the Kapha dosha, one of the three fundamental energies that govern the body. According to WHO More than 1 billion people worldwide are obese, WHO estimates that by 2025, Approximately 167 million people will become less healthy because they are overweight or obese. If any attempt is not taken to prevent obesity, it leads to various disorders like Hypertension Diabetes Cardiac disease etc. |