| CTRI Number |
CTRI/2025/09/094607 [Registered on: 11/09/2025] Trial Registered Prospectively |
| Last Modified On: |
10/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A study of different homoeopathic potencies in the management of uterine fibroids in adult females |
|
Scientific Title of Study
|
Comparative study on the efficacy of Centesimal potency VS. Fifty Millesimal potency in the management of Uterine Fibroids in women of reproductive-age (15 to 50 years) |
| 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 Sanhita Vasdev |
| Designation |
PG student |
| Affiliation |
Dr D Y Patil Homoeopathic Medical College And Research Centre Pune |
| Address |
PG student department of Organon of Medicine and Homoeopathic Philosophy Dr D Y Patil Homoeopathic Medical College And Research Centre Sant Tukaram Pimpri Pune
Pune
MAHARASHTRA
412303
India |
| Phone |
9650983234 |
| Fax |
|
| Email |
sanhitavasdev@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanhita Vasdev |
| Designation |
PG |
| Affiliation |
Dr D Y Patil Homoeopathic Medical College And Research Centre Pune |
| Address |
Dr D Y Patil Homoeopathic Medical College And Research Centre Sant Tukaram Pimpri Pune
MAHARASHTRA
412303
India |
| Phone |
9650983234 |
| Fax |
|
| Email |
sanhitavasdev@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sucharita Kulkarni |
| Designation |
Professor |
| Affiliation |
Dr D Y Patil Homoeopathic Medical College And Research Centre Pune |
| Address |
Dr D Y Patil Homoeopathic Medical College And Research Centre Sant Tukaram Pimpri Pune
Pune
MAHARASHTRA
412303
India |
| Phone |
9422084200 |
| Fax |
|
| Email |
sucharita.kulkarni@dpu.edu.in |
|
|
Source of Monetary or Material Support
|
| OPD and IPD complex Department of Organon of Medicine and Homoeopathic Philosophy ground floor Dr D Y Patil Homoeopathic Medical College and Research Centre Sant Tukaram Nagar Pimpri Pune 411018 Maharashtra India |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
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 Sanhita Vasdev |
Dr D Y Patil Homoeopathic Medical College and Research Centre Sant Tukaram Nagar Pimpri Pune 411018 |
OPD and IPD complex first floor Department of Organon of Medicine and Homoeopathic philosophy ground floor
Pune
MAHARASHTRA |
09650983234
sanhitavasdev@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr D Y Patil Homoeopathic Medical College Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D259||Leiomyoma of uterus, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualized Homoeopathic Medicine |
Individualized Homoeopathic Medicine in Centesimal scale |
| Comparator Agent |
Individualized Homoeopathic Medicine |
Individualized Homoeopathic Medicine in Fifty Millesimal scale |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
Females of reproductive age group 15 to 50
Diagnosed cases of uterine fibroid
Cases with symptoms related to uterine fibroids
Females with fibroid size less than or equal to 5cm
|
|
| ExclusionCriteria |
| Details |
Females of age below 15 and above 50
Menopausal females
Females with other complications such as PCOS
Females with fibroid size more than 5cm
Females suffering with severe anaemia |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the reduction in size of uterine fibroid |
To assess the reduction in size of uterine fibroid in 4 to 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the symptomatic relief in the patients as per Uterine fibroid symptom & health-related quality of life questionnaire |
To assess the symptomatic relief of the patient in 3 to 4 months |
|
|
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)
|
30/10/2025 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
According to the recent research there has been a surge in the cases of uterine fibroids seen in the past decade The clinical evidence about the utility of Homoeopathy in managing uterine fibroids is limited The previous research either helped to manage the troublesome symptoms or showed decrease in the size of fibroids As Homoeopathy acts on the whole individual not just on the diseased part This comparative study of two different scale aims to explore the role of Homoeopathy as a holistic approach towards uterine fibroids with the help of two different potencies that is centesimal scale and fifty millesimal scale given by Dr Hahnemann in 5th and 6th edition of Organon of Medicine respectively to see if there is any difference in the efficacy of the two potencies in the case of uterine fibroid studied in the reproductive age group that is 15 to 50 years |