| CTRI Number |
CTRI/2021/02/030985 [Registered on: 04/02/2021] Trial Registered Prospectively |
| Last Modified On: |
03/02/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Study to compare the effect of Abhaya Choorna and Abhaya Choorna with Vyayam in Obesity |
|
Scientific Title of Study
|
Clinical Study To Evaluate the Efficacy Of Abhaya Choorna And Abhaya Choorna With Vyayam In Sthaulya |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Snehal Kedar |
| Designation |
MD Scholar |
| Affiliation |
Dr D Y Patil College Of Ayurveda And Research Center ,Sant Tukaram Nagar,Pimpri,pune. |
| Address |
Dr D Y Patil College Of Ayurveda And Research Center,Ayurved Samhita And Siddhant Department (4th floor)Room No-2,Sant Tukaram Nagar pimpri,Pune.
Pune
MAHARASHTRA
411018
India |
| Phone |
8408044021 |
| Fax |
|
| Email |
snehalkedar15@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrMrudula Joshi |
| Designation |
Proffessor and H.O.D. |
| Affiliation |
Dr D Y Patil College Of Ayurveda And Research Center ,Sant Tukaram Nagar,Pimpri,pune. |
| Address |
Dr D Y Patil College Of Ayurveda And Research Center,Ayurved Samhita And Siddhant Department (4th floor)Room No-2, Sant Tukaram Nagar pimpri,Pune.
Pune
MAHARASHTRA
411018
India |
| Phone |
8408044021 |
| Fax |
|
| Email |
mrudula.doctor@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Snehal Kedar |
| Designation |
MD Scholar |
| Affiliation |
Dr D Y Patil College Of Ayurveda And Research Center ,Sant Tukaram Nagar,Pimpri,pune. |
| Address |
Dr D Y Patil College Of Ayurveda And Research Center,Ayurved Samhita And Siddhant Department (4th floor)Room No-2, Sant Tukaram Nagar pimpri,Pune.
Pune
MAHARASHTRA
411018
India |
| Phone |
8408044021 |
| Fax |
|
| Email |
snehalkedar15@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr D Y Patil College Of Ayurved And Research Center,Ayurved Samhita And Siddhant Department (4th floor)Room No-2,Sant Tukaram Nagar,Pimpri,Pune.Maharashtra |
|
|
Primary Sponsor
|
| Name |
Snehal Kedar |
| Address |
Dr D Y Patil College Of Ayurveda And Research Center,Ayurved Samhita And Siddhant Department (4th floor)Room No-2,Sant Tukaram Nagar,Pimpri,Pune. |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Snehal Kedar |
Dr D Y Patil College Of ayurveda Research Center |
Kayachikitsa OPD ,Ground floor,room no.15,Dr D Y patil College Of Ayurveda and Research Center,Sant Tukaram Nagar,pimpri,pune.
Pune
MAHARASHTRA |
8408044021
snehalkedar15@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethics committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E669||Obesity, unspecified. Ayurveda Condition: STHAULYA, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Abhaya Choorna |
Abhaya Choorna 3 gm will be given in two divided doses ,before meals-2 times with anupana of koshna jala. |
| Comparator Agent |
Abhaya choorna With Vyayam |
Abhaya Choorna 3 gm will be given in two divided doses before meals-2 times With anupana of koshna jala And Vyayam ( Walking ) |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient having age 16-40 yrs.
2.BMI above 30 were selected
3.Predominant kapha prakruti patients were selected
4.Uncomplicated sthaulya Patients were selected
5.Diagnosed patients of sthaulya
5.Patients willing to take treatment |
|
| ExclusionCriteria |
| Details |
1.Patients not willing for treatment
2.Any discomfort found during treatment
3.Obesity due to Certain secondary cause like pregnancy,drug induced
4.Sthaulya with jwara,prameha,pramehapeedaka etc.
5.Who have undergone blood letting therapy |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Abhaya choorna is effective in the management of sthaulya patient |
21 days study with 3 follow ups (7,14,21) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Abhaya choorna along with Vyayam(Walking) is more effictive in sthaulya patients |
21 days study with 3 follow ups (7,14,21) |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
05/02/2021 |
| 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
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The aim of the study is to see comparative effect of abhaya choorna and Abhaya choorna along with vyayama with anupana koshna jala in management of sthaulya patient.The study will be conducted with 60 patients showing sign and symptoms of sthaulya patient (16 years -40 years age )They will be adminstered with Abhaya choorna 3 gm in divided doses with koshna jala for 21 days and follow up done on 7,14 and 21st day and conclusion will be drawn on the basis of statistically methode. |