| CTRI Number |
CTRI/2022/10/046268 [Registered on: 07/10/2022] Trial Registered Prospectively |
| Last Modified On: |
03/10/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [Oral application of drug ] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
TO SEE THE EFFECT OF MUSTAK AND VACHA IN OBESITY |
|
Scientific Title of Study
|
An analytical study and clinical evaluation of Mustak and Vacha in Obesity |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Srishti Kharkwal |
| Designation |
PhD Scholar |
| Affiliation |
Rishikul Campus, UAU, Haridwar |
| Address |
Dravyaguna department, Rishikul Campus, UAU, Haridwar, Dravyguna OPD Rishikul Campus, UAU, Haridwar
Dravyaguna department,Patanjali Ayurved College, Patanjali Yogpeeth, phase 1, Haridwar 249405
Hardwar
UTTARANCHAL
249404
India |
| Phone |
8979952020 |
| Fax |
|
| Email |
s.srishti2018@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Srishti Kharkwal |
| Designation |
PhD Scholar |
| Affiliation |
Rishikul Campus, UAU, Haridwar |
| Address |
Dravyaguna department, Rishikul Campus, UAU, Haridwar, Dravyguna OPD Rishikul Campus, UAU, Haridwar
Dravyaguna department,Patanjali Ayurved College, Patanjali Yogpeeth, phase 1, Haridwar 249405
Hardwar
UTTARANCHAL
249404
India |
| Phone |
8979952020 |
| Fax |
|
| Email |
s.srishti2018@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Dr D C Singh |
| Designation |
Professor and HOD, Campus Director |
| Affiliation |
Rishikul Campus, UAU, Haridwar |
| Address |
Dravyaguna department, Rishikul Campus, UAU, Haridwar, Dravyguna OPD Rishikul Campus, UAU, Haridwar
Hardwar
UTTARANCHAL
249404
India |
| Phone |
9411175362 |
| Fax |
|
| Email |
drdcschauhan@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rishikul Campus,UAU, Haridwar |
|
|
Primary Sponsor
|
| Name |
Uttarakhand Ayurved University |
| Address |
Dravyaguna Department, Rishikul Campus, UAU, Haridwar |
| 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 Srishti Kharkwal |
Rishikul Campus, UAU, Haridwar |
P.G. Department of Dravyaguna
Rishikul Campus, UAU, Haridwar,249401
Hardwar
UTTARANCHAL |
8979952020
s.srishti2018@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE OF UTTARAKHAND AYURVED UNIVERSITY RISHIKUL CAMPUS HARIDWAR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E660||Obesity due to excess calories. Ayurveda Condition: MEDOROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Mustak and Vacha, Reference: Lekhaniya Mahakashaya 4/3, Route: Oral, Dosage Form: Sattva, Dose: 5.5(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -lukewarm water ), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Mustak, Reference: Lekhaniya Mahakashaya Charak4/3, Route: Oral, Dosage Form: Sattva, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -lukewarm water), Additional Information: - | | 3 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Vacha, Reference: Lekhaniya Mahakashaya 4/3, Route: Oral, Dosage Form: Sattva, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Patients having cardinal signs and symptoms of Obesity
BMI More than 25kg/m2
Waist hip ratio more than and equals to 0.95 in males and 0.8 in females |
|
| ExclusionCriteria |
| Details |
Obesity due to secondary causes like Hypothyroidism diabetes and other systemic diseases |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the efficacy of Mustak and Vacha extract in patient of Obesity in terms of weight loss, lipid profile etc. |
3months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assessment of Sign and symptoms of obese person in terms of weight loss, lipid profile, hip:waist ratio etc. |
4weeks |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
10/10/2022 |
| 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
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
In this study we will do analytical study of Mustak and Vacha and clinical trial of Mustak and vacha extract in patients of Obesity. Dose of 5g of Mustak and 500mg of Vacha will be taken to see the effect of these drugs in patient of obesity. |