| CTRI Number |
CTRI/2025/09/094732 [Registered on: 12/09/2025] Trial Registered Prospectively |
| Last Modified On: |
12/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Use of Homoeopathic remedies Garcinia Cambogia and Phytolacca Berry in reducing Obesity |
|
Scientific Title of Study
|
Garcinia Cambogia and Phytolacca Berry Mother tincture in management of Obesity:A Single Blind,Randomised Comparative Study |
| 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 Kavita Raju Mudawat |
| Designation |
PG Scholar |
| Affiliation |
Bharati Vidyapeeth (Deemed To Be University)Homoeopathic Medical College and Hospital |
| Address |
Bharati Vidyapeeth(Deemed To Be University)Homoeopathic Medical College and Hospital, Department of Postgraduate and Research Centre,Dhankawadi,Satara road, Pune
Pune
MAHARASHTRA
411043
India |
| Phone |
8788949078 |
| Fax |
|
| Email |
kavita.mudawat-hmcpune@bvp.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Swati R Shinde |
| Designation |
Professor |
| Affiliation |
Bharati Vidyapeeth (Deemed To Be University) Homoeopathic Medical College and Hospital |
| Address |
Bharati Vidyapeeth(Deemed To Be University)Homoeopathic Medical College and Hospital, Department of Postgraduate and Research Centre, Dhankawadi, Satara road, Pune
Pune
MAHARASHTRA
411043
India |
| Phone |
9890140393 |
| Fax |
|
| Email |
swati.shinde@bharatividyapeeth.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Swati R Shinde |
| Designation |
Professor |
| Affiliation |
Bharati Vidyapeeth (Deemed To Be University) Homoeopathic Medical College and Hospital |
| Address |
Bharati Vidyapeeth(Deemed To Be University)Homoeopathic Medical College and Hospital, Department of Postgraduate and Research Centre, Dhankawadi, Satara road, Pune
Pune
MAHARASHTRA
411043
India |
| Phone |
9890140393 |
| Fax |
|
| Email |
swati.shinde@bharatividyapeeth.edu |
|
|
Source of Monetary or Material Support
|
| Bharati Vidyapeeth (Deemed To Be University)Homoeopathic Medical College and Hospital, Department of Postgraduate and Research centre, Dhankawadi, Satara road, Pune 411043 |
|
|
Primary Sponsor
|
| Name |
Dr Kavita Raju Mudawat |
| Address |
Bharati Vidyapeeth (Deemed To Be University)Homoeopathic Medical College and Hospital, Department of Postgraduate and Research Centre, Dhankawadi, Satara road,Pune 411043 |
| 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 Kavita Raju Mudawat |
Bharati Vidyapeeth (Deemed To Be University) Homeopathic Medical College and Hospital ,Pune |
Bharati Vidyapeeth(Deemed To Be University)Homoeopathic Medical College and Hospital, Department of Postgraduate and Research Centre, Dhankawadi, Satara road, Pune 411043
Pune
MAHARASHTRA |
8788949078
kavita.mudawat-hmcpune@bvp.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Bharati Vidyapeeth(Deemed To Be University) Homoeopathic Medical College and Hospital, Department of Postgraduate and Research Centre, Dhankawadi, Satara road, Pune 411043 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E669||Obesity, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Garcinia Cambogia mother tincture |
15 drops in half cup of water,Three times daily before meal |
| Comparator Agent |
Phytolacca Berry Mother tincture |
15 drops in half cup of water, Three times daily before meal |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Patient presenting with Obesity with BMI 30.0 to 39.9 kg/m2(Obese Class l and ll) |
|
| ExclusionCriteria |
| Details |
1.Pregnancy or lactation
2.Individuals with BMI more than and equal to 40kg/m2
3.Current use of corticosteroid or appetite suppressants
4.Chronic systemic diseases eg.Cancer, Renal failure, Cardiac diseases
5.Type 2 Diabetes mellitus with complications
6.Individuals with eating disorder eg.Bulimia nervosa |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in BMI |
From baseline to three months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in Waist to hip ratio, Waist circumference |
From baseline to three months |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
23/09/2025 |
| 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 - NO
|
|
Brief Summary
|
Garcinia Cambogia and Phytolacca Berry Mother tincture in management of Obesity:A Single Blind, Randomised Comparative clinical trial A total of 30 participants(15 in each group) fulfilling the inclusion criteria will be included. Participants will be randomly allocated into two groups.Group A will receive Garcinia Cambogia Mother tincture 15 drops in half cup of water, Three times daily before meal and Group B will receive Phytolacca Berry Mother tincture 15 drops in half cup of water, Three times daily before meal.Follow up assessment will be assessed every 15 days with BMI, waist hip ratio and waist circumference reassessed every three months over the total study duration of one year. Final assessment will compare initial and final change in BMI, Waist hip ratio and waist circumference . Study aims to evaluate and compare the efficacy of Garcinia Cambogia and Phytolacca Berry Mother tincture in management of Obesity. |