| CTRI Number |
CTRI/2019/03/018273 [Registered on: 26/03/2019] Trial Registered Prospectively |
| Last Modified On: |
18/03/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to study the effect of two Ayurvedic medicines in patients with Obesity |
|
Scientific Title of Study
|
An open label randomised clinical study to compare the efficacy of Lekhaniyagana Mahakashaya and Musthadi Kashaya in Obesity |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| En No 17AYU6AYU1007 dated 01 July 2017 Version 01 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Deepthi M S |
| Designation |
Principal Investigator |
| Affiliation |
Rajiv Gandhi Ayurveda Medical College |
| Address |
Department of Kayachikitsa
Rajiv Gandhi Ayurveda Medical College
Chalakkara
New Mahe
673311
Mahe
PONDICHERRY
673311
India |
| Phone |
9946641883 |
| Fax |
|
| Email |
msdeepthi80@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ratnaprava Mishra |
| Designation |
Guide |
| Affiliation |
Mandsaur University |
| Address |
Department of Kayachikitsa
Mandsaur Institute of Ayurved & Research
Mandsaur University
Mandsaur
Madhya Pradesh
458001
Mandsaur
MADHYA PRADESH
458001
India |
| Phone |
8281931485 |
| Fax |
|
| Email |
dr.rpmishra@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ratnaprava Mishra |
| Designation |
Guide |
| Affiliation |
Mandsaur University |
| Address |
Department of Kayachikitsa
Mandsaur Institute of Ayurved & Research
Mandsaur University
Mandsaur
Madhya Pradesh
458001
Mandsaur
MADHYA PRADESH
458001
India |
| Phone |
8281931485 |
| Fax |
|
| Email |
dr.rpmishra@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Deepthi M S
Assistant Professor
Department of Kayachikitsa
Rajiv Gandhi Ayurveda Medical College
Chalakkara
New Mahe 673311 |
|
|
Primary Sponsor
|
| Name |
Deepthi M S |
| Address |
Assistant Professor
Department of Kayachikitsa
Rajiv Gandhi Ayurveda Medical College
Chalakkara
New Mahe 673311 |
| Type of Sponsor |
Other [Investigator initiated study] |
|
|
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 Deepthi M S |
Rajiv Gandhi Ayurveda Medical College |
Department of Kayachikitsa
Chalakkara
New Mahe 673311
Mahe
PONDICHERRY |
9946641883
msdeepthi80@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Mandsaur Institute of Ayurved Education and Research,Madhya Pradesh 458001 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E660||Obesity due to excess calories, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Lekhaniyagana Mahakashaya |
50ml Lekhaniyagana Mahakashaya orally on empty stomach given twice daily for 84 days.Follow up done on 14th and 28th day after treatment |
| Comparator Agent |
Musthadi Kashaya |
50ml Musthadi kashaya orally on empty stomach given twice daily for 84 days. Follow up done on 14th and 28th day after treatment |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients having signs and symptoms of Sthoulya
Patients from age group 30-60 years
Patient of both genders
Patients having BMI >25 and <40 |
|
| ExclusionCriteria |
| Details |
Drug induced Obesity
Obesity due to certain secondary causes
Hormonal disorders
Pregnant women
Disease associated obesity patient |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in weight |
biweekly assessment upto84th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Body Mass Index
Measuring skinfold thickness
Measuring Girth circumference
Subjective symptoms
|
Day1,Day14,Day28,Day42,Day56,
Day70,Day84 |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
01/04/2019 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
No publications yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is a study conducted as part of the PhD thesis submission at Mandsaur University, Madhya Pradesh,India.Obesity is one of the major issue that people and health care professionals are facing presently.This life style disorder is caused as a result of over nutrition which mostly affects the middle age.The pupose of the study is to compare the efficacy of two Ayurvedic medicines in Obesity |