| CTRI Number |
CTRI/2025/03/081678 [Registered on: 05/03/2025] Trial Registered Prospectively |
| Last Modified On: |
04/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Other (Specify) [Dietary intervention] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of shyamak(sama chawal) and diet restriction for treatment of overweight. |
|
Scientific Title of Study
|
A Comparative Study to Evaluate the Efficacy of Shyamak(Echinochloa frumentacea Linn.)and diet restriction in Sthoulya- A randomized control trial |
| 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 Sandwana Sajan |
| Designation |
PG Scholar Dept. Of Swasthavritta |
| Affiliation |
Chaudhary Brahm Prakash Ayurved Charak Sansthan |
| Address |
Room No 222 PG Department of Swasthavritta Chaudhary Brahm Prakash Ayurved Charak Sansthan Khera Dabar Najafgarh Delhi
South West
DELHI
110073
India |
| Phone |
9400839268 |
| Fax |
|
| Email |
sandwanasg1997@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rakesh Kumar Verma |
| Designation |
Associate Professor |
| Affiliation |
Chaudhary Brahm Prakash Ayurved Charak Sansthan |
| Address |
PG Department of Swasthavritta Chaudhary Brahm Prakash Ayurved Charak Sansthan Khera Dabar Najafgarh Delhi
South West
DELHI
110073
India |
| Phone |
9818361601 |
| Fax |
|
| Email |
rakeshverma2399@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rakesh Kumar Verma |
| Designation |
Associate Professor |
| Affiliation |
Chaudhary Brahm Prakash Ayurved Charak Sansthan |
| Address |
PG Department of Swasthavritta Chaudhary Brahm Prakash Ayurved Charak Sansthan Khera Dabar Najafgarh Delhi
South West
DELHI
110073
India |
| Phone |
9818361601 |
| Fax |
|
| Email |
rakeshverma2399@gmail.com |
|
|
Source of Monetary or Material Support
|
| Chaudhary Brahm Prakash Ayurved Charak Sansthan,Khera Dabar, Najafgarh, South West Delhi, 110073, India |
|
|
Primary Sponsor
|
| Name |
Chaudhary Brahm Prakash Ayurved Charak Sansthan |
| Address |
Room No. 222, Department of Swasthavritta, Chaudhary Brahm Prakash Ayurved Charak Sansthan,Khera Dabar, Najafgarh, South West Delhi-110073, India |
| Type of Sponsor |
Government 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 |
| Dr Sandwana Sajan |
Chaudhary Brahm Prakash Ayurved Charak Sansthan |
Room No 222, PG Department of Swasthavritta, Institute Block
South West
DELHI |
9400839268
sandwanasg1997@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC CBPACS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E663||Overweight. Ayurveda Condition: SLESHMAVIKARAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Lifestyle | - | - | Dinacarya: , Ritucarya: , Acara Rasayana:, Other:Diet chart for overweight individuals will be provided, Pathya/Apathya:yes, Pathya:Diet chart with food that can be included in diet of overweight individual will be provided., Apathya:Food that cannot be consumed by the person will also be provided in the diet chart at the time of enrollment. | | 2 | Intervention Arm | Lifestyle | - | - | Dinacarya: , Ritucarya: , Acara Rasayana:, Other:Shyamak(barnyard millet) will be included in diet , Pathya/Apathya:yes, Pathya:Diet chart with food that can be included in diet of overweight individual will be provided., Apathya:Food that cannot be consumed by the person will also be provided in the diet chart at the time of enrollment. |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Body mass index between 25to29.9kilogram/meter square
Waist hip ratio greater than 0.95(in males)
Waist hip ratio greater than 0.80(in females)
Subjects willing to carry out treatment for 30 days.
Subjects will be registered with duly signed informed consent prior to trial.
|
|
| ExclusionCriteria |
| Details |
Subjects with thyroid disorders, PCOD, or other chronic systemic disorders.
Pregnant and lactating ladies.
Subjects who have done any surgeries within last 6 months.
Subjects under steroid therapy. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| After completion of trial, results will be analysed and documented.Shyamak and diet restriction are expected to reduce weight in overweight individuals. |
Assessed on 0th, 15th, and 30th day. Follow up after 30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The outcome will be assessed through BMI and WHR of patients. |
Assessed on 0th, 15th, and 30th day. Follow up after 30 days |
|
|
Target Sample Size
|
Total Sample Size="92"
Sample Size from India="92"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
14/03/2025 |
| 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 Yet Recruiting |
| 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
|
The study is randomized control trial to evaluate the efficacy of Shyamak (Echinochloa frumentacea Linn) and diet restriction in overweight individuals. In trial group both diet restriction along with Shyamak(barnyard millet) will be given. In control group only diet restriction will be adviced. The diagnosis will be done on the basis of BMI and WHR. Assessment will be done on 0th day, 15th day and 30th day. Follow up will be done after 30 days. The trial will be conducted in Ch. brahm prakash ayurved charak sansthan with outcome i.e Shyamak and diet restriction are expected to reduce weight in overweight individuals. |