| CTRI Number |
CTRI/2025/01/079110 [Registered on: 21/01/2025] Trial Registered Prospectively |
| Last Modified On: |
21/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to study the effects of two drugs, Madanaphala triphaladi kashayam and Gomutra haritaki vati in patients of Sthaulya (Obesity) |
|
Scientific Title of Study
|
An open label double arm randomized comparative clinical study on the efficacy of madanphala triphaladi kashayam and gomutra haritaki vati in sthaulya |
| 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 Ajay Shinde |
| Designation |
PG scholar |
| Affiliation |
Dhanvatari ayurveda college hospital and research centre siddapur |
| Address |
Dept of PG studies in Kayachikitsa Room no 01 Dhanvantari Ayurveda College Hospital and Research Centre Siddapur Karnataka 581355
Dept of PG studies in Kayachikitsa Room no 01 Dhanvantari Ayurveda College Hospital and Research Centre Siddapur Karnataka 581355
Uttara Kannada
KARNATAKA
581355
India |
| Phone |
9741379547 |
| Fax |
9741379547 |
| Email |
ajayshinde2210@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Roopa Bhat |
| Designation |
Principle and HOD Dept of Kayachikitsa |
| Affiliation |
Dhanvatari ayurveda college hospital and research centre siddapur |
| Address |
Dept of PG studies in Kayachikitsa Room no 01 Dhanvantari Ayurveda College Hospital and Research Centre Siddapur Karnataka 581355
Dept of PG studies in Kayachikitsa Room no 01 Dhanvantari Ayurveda College Hospital and Research Centre Siddapur Karnataka 581355
Uttara Kannada
KARNATAKA
581355
India |
| Phone |
9845301333 |
| Fax |
9845301333 |
| Email |
ayurroopa@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ajay Shinde |
| Designation |
PG scholar |
| Affiliation |
Dhanvatari ayurveda college hospital and research centre siddapur |
| Address |
Dept of PG studies in Kayachikitsa Room no 01 Dhanvantari Ayurveda College Hospital and Research Centre Siddapur Karnataka 581355
Dept of PG studies in Kayachikitsa Room no 01 Dhanvantari Ayurveda College Hospital and Research Centre Siddapur Karnataka 581355
Uttara Kannada
KARNATAKA
581355
India |
| Phone |
9741379547 |
| Fax |
9741379547 |
| Email |
ajayshinde2210@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dhanvantari Ayurveda Medical College and Hospital and Research Centre Siddapur, Near forest check post, siddapur-581355, T- Siddapur, Dist- Uttara kannada, Karnataka, India, |
|
|
Primary Sponsor
|
| Name |
DR Ajay Shinde |
| Address |
Boys Hostel, Dhanwantari Ayurveda College Siddapur-581355,T- Siddapur, Dist- Uttara Kannada, Karnataka, India. |
| 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 |
| DR Ajay Shinde |
Dhanvantari Ayurveda Hospital |
Dhanvantari Ayurveda Medical Near forest check post, Siddapur 581355, T- Siddapur, Dist- Uttara kannada, Karnataka, India. Dept of Kaya Chikitsa, General Ward, Room No 01
Uttara Kannada
KARNATAKA |
9741379547
9741379547
ajayshinde2210@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Dhanvantari Ayurveda College Hospital and Research Centre Siddapur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E663||Overweight. Ayurveda Condition: MEDOROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Madanaphala Triphaladi Kashayam, Reference: Ashtanga Sangraha Sutrasthana, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 15(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Ushna Jala), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Gomutra Haritaki Vati, Reference: Ashtanga Hrudaya Chikitsasthana, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Ushna Jala), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients having cardinal signs and symptoms of sthaulya.
B.M.I. 25 to 39.9 kg/m2.
Willing to give written informed consent. |
|
| ExclusionCriteria |
| Details |
1.Age below 16years and above 60years
2.Diagnosed cases of Diabetes, Cardio pulmonary diseases, Thyroid disorders, Parkinsonism
3.Pregnant and Lactating women
4.B.M.I below 25kg/m2 and above 40kg/m2 |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the efficacy of Madanphala Triphaladi Kashayam & Gomutra Haritaki Vati in Sthaulya |
0 15 31 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the efficacy of both Madanphala Triphaladi Kashayam & Gomutra Haritaki Vati in Sthaulya |
0, 14 & 31st days |
|
|
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
02/02/2025 |
| 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) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [ajayshinde2210@gmail.com].
- For how long will this data be available start date provided 05-09-2023 and end date provided 05-08-2024?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This is an Open Label Double Arm Randomized Comparative Clinical Study on the Efficacy of Madanphala Triphaladi Kashayam and Gomutra Haritaki Vati in Sthaulya which is being conducted in Dhanvantari Ayurveda College and Hospital, Siddapur Karnataka as part of PG thesis. The subjects will be divided into two groups, each comprising of 20 patients and will be intervened with both trial as well as standard drug for a duration of 30 days to assess its efficacy in Sthaulya Roga and the parameters will be assessed every 7 days once during the duration of intervention |