| CTRI Number |
CTRI/2025/11/097585 [Registered on: 17/11/2025] Trial Registered Prospectively |
| Last Modified On: |
04/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of Folliculinum on Menstrual cycles in Women with PCOS |
|
Scientific Title of Study
|
Effectiveness of Folliculinum in regulating Menstrual cycles in women with PCOS a single arm prospective clinical 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 Shrishti |
| Designation |
PG Scholar |
| Affiliation |
Bakson Homoeopathic Medical College and Hospital |
| Address |
B 17 Department of Practice of Medicine basement Bakson Homoeopathic Medical College and Hospital 36 B Knowledge park phase 1 Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
210310
India |
| Phone |
8439176964 |
| Fax |
|
| Email |
Shrishtityagi56@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vijaya goswami |
| Designation |
Associate professor and guide |
| Affiliation |
Bakson Homoeopathic Medical College and Hospital |
| Address |
B 16 Department of Practice of Medicine basement Bakson Homoeopathic Medical College and Hospital 36 B Knowledge park phase 1 Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
210310
India |
| Phone |
9899602004 |
| Fax |
|
| Email |
vijaya84goswami@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Akshay Mathur |
| Designation |
HOD Professor |
| Affiliation |
Bakson Homoeopathic Medical College and Hospital |
| Address |
B 16 Department of Practice of Medicine basement Bakson Homoeopathic Medical College and Hospital 36 B Knowledge park phase 1 Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
210310
India |
| Phone |
9868121727 |
| Fax |
|
| Email |
drakshaymathur@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bakson Homoeopathic Medical College and Hospital 36B knowledge park phase 1 Greater Noida Uttar Pradesh 210310 |
|
|
Primary Sponsor
|
| Name |
Bakson Homoeopathic Medical College and hospital |
| Address |
Room no G 22 Principal office Ground Floor 36 B Knowledge Park Phase 1 Greater noida |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| NIL |
NOT APPLICABLE |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shrishti |
Bakson Homoeopathic Medical College and Hospital |
OPD Room no 2 ground floor Bakson Homoeopathic Medical College and Hospital 36B knowledge park Phase 1 Greater Noida Uttar pradesh
Gautam Buddha Nagar
UTTAR PRADESH |
8439176964
Shrishtityagi56@gmail.com |
| Dr Shrishti |
Dr. D P Rastogi central Research Institute Homoeopathy |
General Out Patient Department Room No 109 Ground Floor Opposite HCL Sector 24 Noida Gautam Buddha Nagar
UTTAR PRADESH
Gautam Buddha Nagar
UTTAR PRADESH |
8439176964
Shrishtityagi56@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Bakson Homoeopathic Medical College and hospital |
Approved |
| Kendriye homoeopathic anusandhan parishad |
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 |
| Intervention |
Folliculinum |
Oral Route of Administration.
pill form
30 pill size
centesimal scale starting from 30 potency to 10M.
first dose after case taking.
repetition based on follow ups every 4 weeks upto 24 weeks. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Females aged 18–40 years
PCOS diagnosed by Rotterdam 2023 criteria
At least two of the following oligo/amenorrhea Clinical or biochemical hyperandrogenism
Polycystic ovarian morphology
Cycle length more than 35 days
Or less than 21 days Or amenorrhea |
|
| ExclusionCriteria |
| Details |
Current pregnancy or lactation
Ovarian malignancy
Uterine malignancy
Active pelvic inflammatory disease
Severe hepatic impairment
Severe renal impairment
eGFR less than or equal to 30 mL per minute
AST or ALT more than three times normal
Participation in another interventional study within 30 days
Uncontrolled diabetes with HbA1c more than 8.5 percent
Well controlled type 2 diabetes on diet is allowed
Well controlled type 2 diabetes after 4 week washout from metformin is allowed
Major psychiatric illness requiring hospitalization in past 6 months
Stable depression or anxiety on unchanged medication for at least 3 months is allowed |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
The objective is to measure the percentage of participants who develop a regular menstrual pattern after six months of Folliculinum
A regular cycle is defined as 21 to 35 days with bleeding lasting no longer than seven days
Another objective is to assess changes in cycle related quality of life as reported by participants
This will be measured using a validated PCOS specific questionnaire |
Total 16 months
Enrollment period 6 months
Follow up 6 months
Data Analysis 2 months
Report writing 2 months
PCOS Questionnaire at baseline and end |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To track and compare pre and post treatment ultrasound findings
The focus is on ovarian structure and on average ovarian volume and also on antral follicle count
Another objective is to monitor adverse events and to record adverse events and also to interpret adverse events And the adverse events related to Folliculinum |
Total 16 months
Enrollment period 6 months
Follow up 6 months
Data Analysis 2 months
Report writing 2 months
Ultrasound at baseline and end |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
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)
|
22/11/2025 |
| 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="4"
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
|
Role of Folliculinum in managing the irregular menstrual cycles in women with PCOS Total 36 women will be enrolled PCOS Questionnaire and USG will be assessed at baseline and end and Man Whitney U test will be assessed at baseline and 6 month |