| CTRI Number |
CTRI/2024/07/071330 [Registered on: 25/07/2024] Trial Registered Prospectively |
| Last Modified On: |
24/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To find the difference between Mushkakadi Gana Churna Udvartana and Triphala Gana Churna in obesity |
|
Scientific Title of Study
|
Evaluation of Comparative Efficacy of Mushkakadi Gana Udvartana Vs Triphala Gana Udvartana in the management of Obesity (Sthoulya) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kashmira Bhaidkar |
| Designation |
PG Scholar |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Room no 40 Department of Panchakarma Mahatma Gandhi Ayurveda College Hospital and Research Centre Hirapur Salod Wardha Maharashtra 442001 India
Wardha
MAHARASHTRA
442001
India |
| Phone |
7829813131 |
| Fax |
|
| Email |
kashmirabhaidkar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kashmira Bhaidkar |
| Designation |
PG Scholar |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Room no 40 Department of Panchakarma Mahatma Gandhi Ayurveda College Hospital and Research Centre Hirapur Salod Wardha Maharashtra 442001 India
Wardha
MAHARASHTRA
442001
India |
| Phone |
7829813131 |
| Fax |
|
| Email |
kashmirabhaidkar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vinod Ade |
| Designation |
Professor |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Room no 40 Department of Panchakarma Mahatma Gandhi Ayurveda College Hospital and Research Centre Hirapur Salod Wardha Maharashtra 442001 India
Wardha
MAHARASHTRA
442001
India |
| Phone |
9689365368 |
| Fax |
|
| Email |
dr.vinodade@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mahatma Gandhi Ayurveda College and Research Centre Hirapur Salod Wardha |
|
|
Primary Sponsor
|
| Name |
Mahatma Gandhi Ayurveda College and Research Centre Hirapur Salod Wardha |
| Address |
Room 40 Department of Panchakarma Mahatma Gandhi Ayurveda College and Research Centre Hirapur Salod Wardha |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Kashmira Bhaidkar |
Mahatma Gandhi Ayurveda College Hospital and Research Centre |
Room no 40 Department of Panchakarma Mahatma Gandhi Ayurveda College Hospital and Research Centre Wardha
Wardha
MAHARASHTRA |
7829813131
kashmirabhaidkar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Mahatma Gandhi Ayurveda College Hospital and Research Centre Institutional Ethics Committee Salod Wardha |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E669||Obesity, unspecified. Ayurveda Condition: MEDOROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | udvartanam, उदà¥à¤µà¤°à¥à¤¤à¤¨à¤®à¥ | (Procedure Reference: Sushruth Samhita , Procedure details: Subiect will be introduced to medicine as per scheduled.
Udvartanam will be carried out using Triphala Gana for 30 to 45 minutes per day for 15 days.)
(1) Medicine Name: Triphala gana , Reference: Sushruth Samhita , Route: Topical, Dosage Form: Churna/ Powder, Dose: 250(g), Frequency: od, Duration: 15 Days | | 2 | Intervention Arm | Procedure | - | udvartanam, उदà¥à¤µà¤°à¥à¤¤à¤¨à¤®à¥ | (Procedure Reference: Sushruth Samhita , Procedure details: Subiect will be introduced to medicine as per scheduled.
Udvartana will be carried out using Mushkakadi Gana for 30 to 45
minutes per day for 15 days.)
(1) Medicine Name: Mushkakadi Gana , Reference: Ashtang Hrudayam , Route: Topical, Dosage Form: Churna/ Powder, Dose: 250(g), Frequency: od, Duration: 15 Days |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients willing to participate after signing informed consent
Patients between age group of 20-60 years of either sex
Patients having BMI greater than 30 up to 40 kg per meter square |
|
| ExclusionCriteria |
| Details |
Known case of Diabetes mellitus Cardiovascular and Renal Disorder Drug induced Obesity Hypothyroidism PCOS PCOD and any skin ailment
Pregnant lady and Lactating mothers
Not willing to continue treatment
Any other illness developed during treatment |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the efficacy of Mushkakadi Gana Churna Udvartana with reduction in weight BMI skin fold thickness anthropometric measurements |
15days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the efficacy of Triphala Gana Churna Udvartana with reduction in weight BMI skin fold thickness |
15 days |
|
|
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
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
01/09/2024 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The volunteer will be informed about the study protocol. Willing patients will be randomly selected as per computer generated table. Clinical research format will be prepared and validated. Prior to study approval will be taken from IEC, MGACHRC, Salod (H) Wardha and CTRI registration will be done. After selection, each patient will be assessed and selected accordingly to selection criteria. They are divided into two groups the trial is a Randomized single blind reference standard control superiority trial. It will include 17 days treatment and 16th day follow up period.
|