| CTRI Number |
CTRI/2026/01/101721 [Registered on: 21/01/2026] Trial Registered Prospectively |
| Last Modified On: |
21/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Homeopathy
Other (Specify) [Constitutional approach in homoeopathy] |
| Study Design |
Other |
|
Public Title of Study
|
To study the utility of homoeopathic medicine in Menopausal Syndrome |
|
Scientific Title of Study
|
Utility of constitutional approach in homoeopathic management of Menopausal syndrome by using modified naranjo criteria An experimental 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 Mehanaz Farooque Desai |
| Designation |
PG Scholar |
| Affiliation |
Dr J J Magdum Homoeopathic medical college jaysingpur |
| Address |
Department of Organon of medicine and homoeopathic philosophy division homoeopathy room no 16 Dr J J Magdum homoeopathic medical college Laxmi Nagar Shirol Wadi road jaysingpur tal shirol dist kolhapur 416101
Kolhapur
MAHARASHTRA
416101
India |
| Phone |
9511634019 |
| Fax |
|
| Email |
mehanazdesai27@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rafat Jinabade |
| Designation |
Guide and professor |
| Affiliation |
Dr J J Magdum Homoeopathic medical college jaysingpur |
| Address |
Department of Organon of medicine and homoeopathic philosophy division homoeopathy room no 16 Dr J J Magdum homoeopathic medical college Laxmi nagar shirol wadi road jaysingpur tal shirol dist kolhapur 416101
Kolhapur
MAHARASHTRA
416101
India |
| Phone |
9881447608 |
| Fax |
|
| Email |
dr.rafat.jinabade@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mehanaz Farooque Desai |
| Designation |
PG Scholar |
| Affiliation |
Dr J J Magdum Homoeopathic medical college jaysingpur |
| Address |
Department of Organon of medicine and homoeopathic philosophy division homoeopathy room no 16 Dr J J Magdum homoeopathic medical college Laxmi nagar shirol wadi road jaysingpur tal shirol dist kolhapur 416101
Kolhapur
MAHARASHTRA
416122
India |
| Phone |
9511634019 |
| Fax |
|
| Email |
mehanazdesai27@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr J J Magdum Homoeopathic Medical college shirol wadi road Laxmi nagar jaysingpur tal shirol dist kolhapur 416101 |
|
|
Primary Sponsor
|
| Name |
Dr Mehanaz Farooque Desai |
| Address |
Dr J J Magdum Homoeopathic Medical college shirol wadi road Laxmi nagar jaysingpur tal shirol dist kolhapur 416101 |
| Type of Sponsor |
Other [Self sponsored] |
|
|
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 Mehanaz Farooque Desai |
Dr J J Magdum Homoeopathic medical college |
Dr J J Magdum Homoeopathic medical college shirol wadi road laxminagar jaysingpur
Kolhapur
MAHARASHTRA |
9511634019
mehanazdesai27@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| DR J J MAGDUM HOMOEOPATHIC MEDICAL COLLEGE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N951||Menopausal and female climactericstates, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Homoeopathic management |
Indivisualised homoeopathic medicine using constitutional approach using naranjo criteria for homoeopathy
Dose 4 globules per dose
Potency as per individual case
Frequency depending upon susceptibility of individual case
Route of administration oral
Duration of intervention 6 months |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Female |
| Details |
Patients suffering from menopausal syndrome ICD-11 code GA30.00 will be selected
Patients having age above 40 and below 55 years will be considered
The selected patients have complaints of menstrual problems vasomotor symptoms emotional disturbances |
|
| ExclusionCriteria |
| Details |
Patients not fulfilling the case definition of menopausal syndrome.
Patients below 40 and above 55 years of age will be excluded
Menopausal cases on medication including hormonal therapy.
Patients are diagnosed with psychiatric diseases.
All Immunocompromised patients. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Outcome assessment will be done by applying modified naranjo criteria for homoeopathy |
Outcome assessment will be done by applying modified naranjo criteria
Baseline 0
Midstudy 3 months (2nd follow up)
Poststudy 6 months (4th follow up) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not applicable |
Not applicable |
|
|
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
01/02/2026 |
| 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
|
This study aims to evaluate the effectiveness of costitutional homoeopathic medicines in management of menopausal syndrome by using Modified naranjo criteria A quasi experimental clinical study will be conducted on 30 patients Participants will recieve constitutional homoeopathic medicines based on detailed case evaluation Study duration is 18 months and outcomes assessment will be done by using MONARCH scale at midstudy 3 months and poststudy at 6 months After data collection data will be analyzed and evaluated with appropriate statistical tesr |