| CTRI Number |
CTRI/2019/07/020219 [Registered on: 16/07/2019] Trial Registered Prospectively |
| Last Modified On: |
12/07/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Management of Shoulya (Obesity) |
|
Scientific Title of Study
|
Pharmaco-Therapeutic Evaluation of Agnimanthadi Yog (Kalpit Yog) in The Management of Sthoulya 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 |
SURENDRA KUMAR VERMA |
| Designation |
PG scholar |
| Affiliation |
Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University College Jodhpur |
| Address |
Dravya guna department, Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University College karwar Jodhpur
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9785415016 |
| Fax |
|
| Email |
suriverma4587@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr L N Sharma |
| Designation |
Associate professor |
| Affiliation |
Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University Jodhpur |
| Address |
Dravya guna department,Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University karwar Jodhpur
Dravya guna department,Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University karwar Jodhpur
Jodhpur
RAJASTHAN
342037
India |
| Phone |
7976965588 |
| Fax |
|
| Email |
drlnsharma5178@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr surendra kumar verma |
| Designation |
PG scholar |
| Affiliation |
Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University Jodhpur |
| Address |
Dravya guna department, Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University College karwar Jodhpur
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9785415016 |
| Fax |
|
| Email |
suriverma4587@mail.com |
|
|
Source of Monetary or Material Support
|
| Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University karwer, Jodhpur |
|
|
Primary Sponsor
|
| Name |
Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University Jodhpur |
| Address |
Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University Jodhpur |
| 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 Manoj Adlakha |
university Hospital of Ayurveda, Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University Jodhpur |
PG Departmnt of Dravyaguna DSRRAU Karwar Road jodhpur
Jodhpur
RAJASTHAN |
7976965588
drmanojarora2503@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Institutional Ethics Committee DSRRAU Jodhpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E669||Obesity, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Agnimanthadi yog |
two capsule (500mg each) BD dose of Agnimanthadi yog with warm water after meal for 60 days |
| Comparator Agent |
Navak Guggulu |
2 tablet (500mg each) dose of Navak Guggulu with warm water for 60days after meal. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1 patients of age group 20 to 60 years of either
sex male and femele
2 Indvidual with abnormal lipid profie
3 BMI of patients was to be more than 26
4 patient willing to sign the consent forms
5 indidual wirh abnormal serum colestrol, serum HDL, |
|
| ExclusionCriteria |
| Details |
1. Patient having history of serious cardiac disorder.
2. Uncontrol hypertention.
3. Uncontrol diabetic mallius.
4. Hyperlipidemia due to drugs.
5. Pregnant woman. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in subjective and objective parameters |
60 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the efficacy of treatments in both groups |
60 Days |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
20/07/2019 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NILL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is open label parallel group trial to compare the efficacy of Agnimanthadi Yog and Navak Guggulu in the management of Obesity. In one group 500mg of Agnimanthadi yog capsule with lukewarm water will be given twice a day after meal for 60 days. In another group 500mg of Navak guggulu tablet will be given twice a day with lukewarm water after meal for 60 days. |