| CTRI Number |
CTRI/2025/10/095531 [Registered on: 01/10/2025] Trial Registered Prospectively |
| Last Modified On: |
30/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Homeopathy |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of Two Types of Homeopathic Treatment on Hormone Balance in Women with Polycystic Ovary Syndrome (PCOS) |
|
Scientific Title of Study
|
A Prospective Comparative Evaluation Of The Effect Of Folliculinum Vs Constitutional Homoeopathic Medicine In Cases Of PCOS, Assessed By The FSH/LH Ratio |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vataliya Mansi Mukeshbhai |
| Designation |
MD Scholar |
| Affiliation |
Rajkot Homoeopathic Medical College |
| Address |
Umrala, Kalavad, Jamnagar, Gujarat, India
103,Department of Gynec and Obstrectics, Rajkot Homeopathic Medical Collage, Gondal Rd, Near Makkam Chowk, Udhyog Nagar Colony, Bhakti Nagar, Rajkot, Gujarat, India 360002
Rajkot
GUJARAT
361160
India |
| Phone |
9638306919 |
| Fax |
|
| Email |
vatliyamanshi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vani Oza |
| Designation |
Professor Of Homoeopathic Materia Medica |
| Affiliation |
Rajkot Homoeopathic Medical College |
| Address |
14, Samanvay Society, Raiya Road, Near Alap Green City, Rajkot, Gujarat, India
103, Department of Gynec and Obstrectics, Rajkot Homeopathic Medical Collage, Gondal Rd, Near Makkam Chowk, Udhyog Nagar Colony, Bhakti Nagar, Rajkot, Gujarat, India 360002
Rajkot
GUJARAT
360007
India |
| Phone |
9428052673 |
| Fax |
|
| Email |
Vanioza8@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vataliya Mansi Mukeshbhai |
| Designation |
MD Scholar |
| Affiliation |
Rajkot Homoeopathic Medical College |
| Address |
Umrala, Kalavad, Jamnagar, Gujarat, India
103, Department of Gynec and Obstrectics, Rajkot Homeopathic Medical Collage, Gondal Rd, Near Makkam Chowk, Udhyog Nagar Colony, Bhakti Nagar, Rajkot, Gujarat, India, 360002.
Rajkot
GUJARAT
361160
India |
| Phone |
9638306919 |
| Fax |
|
| Email |
vatliyamanshi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rajkot Homoeopathic Medical College |
|
|
Primary Sponsor
|
| Name |
Sainath Hospital |
| Address |
Rajkot Homeopathic Medical Collage, Gondal Rd, Near Makkam Chowk, Udhyog Nagar Colony, Bhakti Nagar, Rajkot, Gujarat, India |
| Type of Sponsor |
Other [] |
|
|
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 Mansi Mukeshbhai Vataliya |
Sainath Homoeopathic Hospital |
103, Department of Gynec and Obstetric,Rajkot Homeopathic Medical Collage, Gondal Rd, Near Makkam Chowk, Udhyog Nagar Colony, Bhakti Nagar, Rajkot, Gujarat, India
Rajkot
GUJARAT |
9638306919
vatliyamanshi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee For Human Research - Rajkot Homoeopathic Medical College [RHMC], Parul University, Gujarat. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E282||Polycystic ovarian syndrome, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Constitutional homeopathic medicines |
Potency and dose: 30c,200c,1M according to susceptibility
Route of administration: orally
Total duration of intervention: 12 month |
| Intervention |
Folliculinum |
Potency and dose: 30c,200c,1M according to susceptibility
Route of administration: orally
Total duration of intervention: 12 month |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Female patients aged 18 to 40 years
Suffering from PCOS for a minimum duration of 6 months and not more than 5 years
Diagnosed with PCOD based on Rotterdam criteria (at least 2 of 3: menstrual irregularity,
clinical/biochemical hyperandrogenism, polycystic ovaries on ultrasound)
Not on hormonal treatment for at least 3 months prior
Willing to follow up for 6 months
Able to understand and communicate in Hindi, Gujarati, English for proper follow-up and
questionnaire completion
Able to provide informed consent |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in serum FSH/LH ratio from baseline to 12 months (or end of treatment), measured in a certified laboratory. |
12 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Menstrual Regularity: Improvement in cycle pattern assessed using Menstrual Regularity Score (MRS) over the 12-month study period.
2. Hirsutism: Change in severity assessed by the Ferriman-Gallwey score.
3. Acne: Change in severity assessed by GAG (Global Acne Grading) Score.
4. Emotional Health: Changes in depression, anxiety, and stress levels measured by DASS-21 scale.
5. Body Weight/BMI: Change in BMI from baseline to end of treatment. |
12 month |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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 4 |
|
Date of First Enrollment (India)
|
15/10/2025 |
| 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="0"
Months="11"
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
|
Polycystic Ovary Syndrome (PCOS) is a common endocrine disorder in women of reproductive age, often associated with menstrual irregularities, hyperandrogenism, and altered FSH/LH ratio. This prospective, randomized, comparative study aims to evaluate the effect of Folliculinum versus individualized constitutional homeopathic medicines on hormonal balance in women with PCOS. A total of 50 female patients, aged 18–40 years, diagnosed according to Rotterdam criteria and not on hormonal treatment for at least 3 months, will be enrolled. Participants will be randomly allocated into two groups: one receiving Folliculinum and the other receiving the individualized constitutional remedy, both for 12 months. The primary outcome is the change in serum FSH/LH ratio from baseline to 12 months. Secondary outcomes include menstrual regularity, hirsutism (Ferriman-Gallwey score), acne severity (GAG score), emotional health (DASS-21), and BMI. Follow-up assessments will occur every 3 months. This study will provide objective evidence on the comparative efficacy of Folliculinum versus constitutional homeopathy in managing PCOS. |