| CTRI Number |
CTRI/2025/08/092441 [Registered on: 05/08/2025] Trial Registered Prospectively |
| Last Modified On: |
04/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to see how personalized homeopathic treatment can help women with PCOS and improve their quality of life |
|
Scientific Title of Study
|
AN INTERVENTIONAL STUDY TO ASSESS THE ROLE OF INDIVIDUALIZED HOMOEOPATHIC MEDICINE IN THE CASES OF POLYCYSTIC OVARIAN SYNDROME USING PCOSQOL SCALE
|
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Falguni Labana |
| Designation |
MD,PGT |
| Affiliation |
Swasthya Kalyan Homoeopathic Medical College and Research Centre,Jaipur |
| Address |
OPD Obg Room number 33 Department Obs Gynae 10-A Sitapura Industrial Area, Tonk Road, Goner Road,
Sitapura Industrial Area, Sitapura, Jaipur, Rajasthan
Jaipur
RAJASTHAN
302022
India |
| Phone |
7688982985 |
| Fax |
|
| Email |
labanafalguni9816.fl@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jagdish Thebar |
| Designation |
Professor and HOD, Depatment of Practice of medicine |
| Affiliation |
Swasthya Kalyan Homoeopathic Medical College and Research Centre,Jaipur |
| Address |
OPD Obg Room number 33 Department Obs Gynae 10-A Sitapura Industrial Area, Tonk Road, Goner Road,
Sitapura Industrial Area, Sitapura, Jaipur, Rajasthan
Jaipur
RAJASTHAN
302022
India |
| Phone |
9829391362 |
| Fax |
|
| Email |
thebarjagdish@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jagdish Thebar |
| Designation |
Professor and HOD, Depatment of Practice of medicine |
| Affiliation |
Swasthya Kalyan Homoeopathic Medical College and Research Centre,Jaipur |
| Address |
OPD Obg Room number 33 Department Obs Gynae 10-A Sitapura Industrial Area, Tonk Road, Goner Road,
Sitapura Industrial Area, Sitapura, Jaipur, Rajasthan
Jaipur
RAJASTHAN
302022
India |
| Phone |
9829391362 |
| Fax |
|
| Email |
thebarjagdish@gmail.com |
|
|
Source of Monetary or Material Support
|
| Swasthya Kalyan Homoeopathic Medical College And Research
Centre, 10-A, Sitapura Institutinal Area, Tonk Road, Goner Road,
Sitapura Industrial Area, Sitapura, Jaipur, Rajasthan |
|
|
Primary Sponsor
|
| Name |
Swasthya Kalyan Homoeopathic Medical College And Research Centre |
| Address |
Swasthya Kalyan Homoeopathic Medical College And Research
Centre, 10-A, Sitapura Institutinal Area, Tonk Road, Goner Road,
Sitapura Industrial Area, Sitapura, Jaipur, Rajasthan |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Jagdish Thebar |
Swasthya Kalyan Homoeopathic Medical College And Research Centre |
OPD Obg Room number 33 Department Obs Gynae 10-A Sitapura Industrial Area, Tonk Road, Goner Road,
Sitapura Industrial Area, Sitapura, Jaipur, Rajasthan
Jaipur
RAJASTHAN |
9829391362
thebarjagdish@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SKHMCIEC |
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 |
Homoeopathic medicines |
•Potency and Dosage: Selection of potency and repetition will be based on Homoeopathic principles.
•Form- Globules No.30
•Route of administration- Sublingual
•Change of medicine and/or dosage if required will be on Homoeopathic principles. |
| Comparator Agent |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1. Female patients of age group 15-45 years.
2. Patients clinically diagnosed with PCOS fulfilling the Rotterdam criteria.
|
|
| ExclusionCriteria |
| Details |
• The Patient suffering from any other disease condition and taking medications which could effect the outcome of the study.
• Patient who will refuse to give consent will be excluded from the study.
• Cases that need surgical intervention.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| •To assess the effectiveness of individualized Homoeopathic medicine in PCOS by using PCOSQOL scale. |
12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| •To determine the most commonly prescribed homoeopathic medicines in PCOS. |
12 months |
|
|
Target Sample Size
|
Total Sample Size="67"
Sample Size from India="67"
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)
|
29/08/2025 |
| 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="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
|
The study is an interventional, nonblind study to assess the effectiveness of individualized homoeopathic medicine in PCOS by using the PCOSQOL scale. The study will be conducted at Swasthya Kalyan Homoeopathic Medical College and Research Centre, Jaipur. |