| CTRI Number |
CTRI/2025/12/098929 [Registered on: 11/12/2025] Trial Registered Prospectively |
| Last Modified On: |
10/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to assess the effect of individualized homoeopathic treatment on menopausal symptoms in women using the Menopause Rating Scale |
|
Scientific Title of Study
|
Effect of Individualized Homoeopathic Medicine selected using Boerickes Pocket Manual Repertory in cases of Menopausal Syndrome assessed by Menopausal Rating Scale: A Prospective Interventional 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 Asmabanu Patel |
| Designation |
PG SCHOLAR |
| Affiliation |
Jawaharlal Nehru Homoeopathic Medical College and Hospital, Parul University |
| Address |
OPD Room Number 103 Jawaharlal Nehru Homoeopathic Medical College and Hospital Parul University Waghodia Vadodara Gujarat 391760
Vadodara GUJARAT 391760 India |
| Phone |
8866207637 |
| Fax |
|
| Email |
afpatel1618@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Neha Makwana |
| Designation |
BHMS, MD Homoeopathy, Associate Professor, PG Department of Homoeopathic Repertory and Case Taking |
| Affiliation |
Jawaharlal Nehru Homoeopathic Medical College and Hospital, Parul University |
| Address |
PG Department of Homoeopathic Repertory and Case Taking Jawaharlal Nehru Homoeopathic Medical College and Hospital Parul University Waghodia Vadodara Gujarat India 391760
Vadodara GUJARAT 391760 India |
| Phone |
7567689625 |
| Fax |
|
| Email |
sadguru95@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Asmabanu Patel |
| Designation |
PG scholar |
| Affiliation |
Jawaharlal Nehru Homoeopathic Medical College and Hospital, Parul University |
| Address |
OPD Room number 103 Jawaharlal Nehru Homoeopathic Medical College and Hospital Parul University Waghodia Vadodara Gujarat India 391760
Vadodara GUJARAT 391760 India |
| Phone |
8866207637 |
| Fax |
|
| Email |
afpatel1618@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal Nehru Homoeopathic Medical College and Hospital, Parul University, Waghodia, Vadodara, Gujarat, India, 391760 |
|
|
Primary Sponsor
|
| Name |
Jawaharlal Nehru Homoeopathic Medical College and Hospital, Parul University |
| Address |
Jawaharlal Nehru Homoeopathic Medical College and Hospital Parul University Waghodia Vadodara Gujarat India 391760 |
| Type of Sponsor |
Private medical college |
|
|
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 Asmabanu Patel |
Jawaharlal Nehru Homoeopathic Medical College and Hospital, Parul University |
OPD Room number 103 Jawaharlal Nehru Homoeopathic Medical College and Hospital Parul University Waghodia Vadodara Gujarat India 391760 Vadodara GUJARAT |
8866207637
afpatel1618@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Jawaharlal Nehru Homoeopathic Medical College - Institutional Ethics Committee For Human Research |
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 |
Individualized Homoeopathic Medicine |
Selection of Homoeopathic medicines, dosages and repetition will be strictly
according to the homoeopathic principles. Each dose 4 pills will be directed to be taken
orally on clean tongue with empty stomach. Duration of therapy 3 months with
follow up at every 15 days. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
1. Women Aged 40-60 Years with Natural Menopause Stage 1 to Stage 2B According to Menopausal Staging by Dr Behram Anklesaria 1997.
2. Women presenting with Menopausal Symptoms with a Menopausal Rating Scale Score less than or is Equal to 9.
3. All Socio- Economic Status.
4. Patients who willing to give Informed Consent and Maintaining Follow Up.
|
|
| ExclusionCriteria |
| Details |
1. Surgical or Chemically induced Menopause.
2. Women who are currently on or have taken Hormonal Replacement Therapy or other Alternative Therapies.
3. Known or Suspected Malignancy.
4. Presence of Major or Sever Systemic Illness. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Marked Improvement
Moderate Improvement
Mild Improvement
No Significant Improvement
Status Quo
Any Increase in Menopausal Rating Scale Score will be counted as worse |
6 Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
01/01/2026 |
| 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="0" 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 addresses menopausal syndrome, a common condition characterized by vasomotor, psychological, somatic, and urogenital symptoms resulting from oestrogen deficiency in middle-aged women, which has a high epidemiological burden due to increasing life expectancy. There is a research gap in systematically generated clinical evidence evaluating the effectiveness of individualized homoeopathic treatment using standardized assessment tools. The study uses the Menopause Rating Scale (MRS) to assess symptom severity and therapeutic response. This prospective interventional single arm clinical study aims to evaluate the effect of individualized homoeopathic medicines selected through Boericke’s Pocket Manual Repertory in cases of Menopausal Syndrome with objectives to assess baseline symptoms, monitor improvement. Forty eligible participants will be recruited from Jawaharlal Nehru Homoeopathic Medical College and Hospital, Vadodara, Gujarat, over a study period of one year. This prospective study expects to demonstrate a significant reduction in MRS scores, supporting the role of individualized homoeopathy as a safe and effective management option for menopausal syndrome. |