| CTRI Number |
CTRI/2018/07/015075 [Registered on: 26/07/2018] Trial Registered Retrospectively |
| Last Modified On: |
21/09/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [Therapeutic] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare the effect of Phalatrikadi Kwath and Vrinda Triphaladi Kwath in obesity |
|
Scientific Title of Study
|
A comparative study to evaluate the efficacy of Phalatrikadi Kwatha and Vrinda-Triphaladi Kwatha in Sthaulya (Obesity). |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prof Dr N R Singh |
| Designation |
Pofessor and HOD |
| Affiliation |
Chaudhary Brahm Prakash Ayurved Charak Sansthan |
| Address |
Chaudhary Brahm Prakash Ayurved Charak Sansthan
Khera Dabar Najafgarh
New Delhi 110073
New Delhi
DELHI
110073
India |
| Phone |
9560659728 |
| Fax |
|
| Email |
naimishraj@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr N R Singh |
| Designation |
Pofessor and HOD |
| Affiliation |
Chaudhary Brahm Prakash Ayurved Charak Sansthan |
| Address |
Chaudhary Brahm Prakash Ayurved Charak Sansthan
Khera Dabar Najafgarh
New Delhi 110073
New Delhi
DELHI
110073
India |
| Phone |
9560659728 |
| Fax |
|
| Email |
naimishraj@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Parul Singh |
| Designation |
P G Scholar |
| Affiliation |
Chaudhary Brahm Prakash Ayurved Charak Sansthan |
| Address |
Chaudhary Brahm Prakash Ayurved Charak Sansthan
Khera Dabar Najafgarh
New Delhi 110073
New Delhi
DELHI
110073
India |
| Phone |
920543184 |
| Fax |
|
| Email |
drparulbhadula@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Kayachikitsa
Chaudhary Brahm Prakash Ayurved Charak Sansthan
Khera Dabar
New Delhi 110073
|
|
|
Primary Sponsor
|
| Name |
Chaudhary Brahm Prakash Ayurved Charak Sansthan |
| Address |
Khera Dabar Najafgarh New Delhi 110073 |
| Type of Sponsor |
Other [Autonomous Ayurvedic Medical college and Hospital under Govt of NCT of Delhi] |
|
|
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 |
| Prof Dr N R Singh |
Chaudhary Brahm Prakash Ayurved Charak Sansthan Khera Dabar New Delhi |
Room no 146 Deptt of Kayachikitsa
New Delhi
DELHI |
9560659728
naimishraj@yahoo.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee CBPACS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E669||Obesity, unspecified, (2) ICD-10 Condition: E669||Obesity, unspecified, Patients of either sex between 21 to 51 yr with BMI ranging from 25.0 to 35 Kg/m2, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Phalatrikadi Kwatha |
20 patients will be given Phalatrikadi kwatha in dose of 40 ml after mixing 12 gm of haridra kalka and 12 ml of honey in it twice in a day (empty stomach in morning and four hour after lunch) for 21 days |
| Comparator Agent |
Vrinda triphaladi Kwatha |
20 patients will be given Vrinda-Triphaladi kwatha in dose of 40 ml after mixing 12 gm of haridra kalka and 12 ml of honey in it twice in a day (empty stomach in morning and four hour after lunch) for 21 days |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
BMI ranging from 25.0 to 35 Kg/m2
Patients willing to participate and provide signed informed consent
|
|
| ExclusionCriteria |
| Details |
Patients with Hypothyroidism
Patients suffering from drug induced Obesity
Patients with Diabetes
Patients with severe Hypertension
Patients with Renal Hepatic and Cardiac involvement
Pregnant and Lactating women
Patients having Gastro intestinal discomfort
Patients who are not willing to participate with the study
9.Any other condition which may jeopardize the study.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Reduction in Weight
Reduction in BMI
Reduction in Waist circumference
Reduction in Hip circumference
Reduction in Waist – Hip Ratio
Reduction in Serum VLDL
Reduction in Serum LDL
Reduction in Serum Triglycerides
Reduction in Serum Total Cholesterol and an increase in Serum HDL
Reduction in percentage relief in subjective criteria of Sthaulya |
Weight
BMI
Waist circumference
Hip circumference
Waist – Hip Ratio
subjective criteria of Sthaulya
on 0 day 21st day and 35th day
Serum VLDL
Serum LDL
Serum Triglycerides
Serum Total Cholesterol
Serum HDL
on 0 day and 21st day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assessment of reduction in the level of abdominal discomfort pain and Frequency of defecation during use of trial medicines |
level of abdominal discomfort pain and Frequency of defecation
on 0 day 7th day 14th day and 21st day |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 4 |
|
Date of First Enrollment (India)
|
18/05/2018 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
According to the inclusion and exclusion criteria patients will be randomly selected from OPD and IPD of Chaudhary Brahm Prakash Ayurved Charak Sansthan Khera Dabar Najafgarh New Delhi Informed written consent will be taken from all the subjects included in the study Patients will be randomly divided into 2 groups of 20 patients each
In group A 20 patients will be given Phalatrikadi kwatha in dose of 40 ml after mixing 12 gm of haridra kalka and 12 ml of honey in it twice in a day empty stomach
in morning and four hour after lunch for 21 days 20 patients will be given Vrinda-Triphaladi kwatha in dose of 40 ml after mixing 12 gm of haridra kalka and 12 ml of honey in it twice in a day empty stomach in
morning and four hour after lunch for 21 days A proforma will be prepared for diagnosis of disease and assessment of subjects BMI Weight Waist circumference Hip Circumference Waist hip Ratio Subjective symptoms and Objective symptoms will be assessed before and after treatment and
during follow up Lipid profile will be done before and after treatment Assessment of abdominal discomfort and abdominal pain and will also be done 0 day 7th day 14th day and 21st day
All the patients will be advised to follow the guidelines regarding pathya-apathya as described in Classical Ayurvedic texts during the trial period
Data will be statistically analyzed at the end of the study period All the ethical issues will be maintained during the clinical trial |