| CTRI Number |
CTRI/2026/01/100169 [Registered on: 01/01/2026] Trial Registered Prospectively |
| Last Modified On: |
31/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Homeopathy |
| Study Design |
Other |
|
Public Title of Study
|
to study the effectiveness of homoeopathic medicine in the managements of polycystic ovary syndrome(PCOS) among females of reproductive age group |
|
Scientific Title of Study
|
Studying effectiveness of individualised homoeopathic medicine in the management of polycystic ovary syndrome among females of reproductive age group-A randomised controlled 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 |
Aparna Kulkarni |
| Designation |
PhD Scholar |
| Affiliation |
Dhondumama Sathe Homoeoepathic Meddical College |
| Address |
Dhondumama Sathe Homoeopathic Medical College and NMRMH hosital karve road , pune
Pune MAHARASHTRA 411004 India |
| Phone |
9822571154 |
| Fax |
|
| Email |
aparna1282@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Maneesha Solanki |
| Designation |
PhD Guide |
| Affiliation |
Dhondumama Sathe Homoeopathc Medical College |
| Address |
Dhondumama sathe homoeopathic medical college and NMRMH hospital , karve road, pune
Pune MAHARASHTRA 411004 India |
| Phone |
9822839740 |
| Fax |
|
| Email |
principaldshmc@gamil.com |
|
Details of Contact Person Public Query
|
| Name |
Aparna Kulkarni |
| Designation |
PhD scholar |
| Affiliation |
DSHMC,Pune |
| Address |
Dhondumama Sathe Homoeopathic Medical College And NMRMH Hospital, karve road ,Pune
Pune MAHARASHTRA 411004 India |
| Phone |
9822571154 |
| Fax |
|
| Email |
aparna1282@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dhondumama Sathe Homoeopathic Medical College and NMRMH hospital ,
Maharashtra, Pune, India- 411004 |
|
|
Primary Sponsor
|
| Name |
Dr Aparna Kulkarni |
| Address |
Dhondumama Sathe Homoeopathic medical College ,karve road, Pune |
| Type of Sponsor |
Other [self] |
|
|
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 |
| Aparna Kulkarni |
Dhondumama Sathe Homoeopathc Medical College |
Dhondumama Stahe Homoeopathic Medical Colllege and NMRMH hospital, Karve Road, Pune Pune MAHARASHTRA |
9822571154
aparna1282@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical committee,DSHMC |
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 |
Individualised homoeopathic medicine |
start with individaulised homoeopathic medicine and basic life style modifications
total duration is 1 year |
| Comparator Agent |
placebo and basic life style modifications |
start with placebo and basic life support total duration 1year |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
49.00 Year(s) |
| Gender |
Female |
| Details |
clinical or biochemical hyperandrogenism
evidence of oligomenorrhoea or anovulation
ultrasonography findings of follicles with polycystic appearing in ovarian morphology |
|
| ExclusionCriteria |
| Details |
diagnosed cases of other endocrinal disorders |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| USG changes and symptomatic relief in polycystic ovary syndrome cases |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| menstrual regularity, reduced acne and hirsutism |
1 year |
|
|
Target Sample Size
|
Total Sample Size="128" Sample Size from India="128"
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 2 |
|
Date of First Enrollment (India)
|
19/01/2026 |
| 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="2" 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
|
TITLE-STUDYING EFFECTIVENESS OF INDIVIDUALISED HOMOEOPATHIC MEDICINE IN THE MANAGEMENT OF POLYCYSTIC OVARY SYNDROME AMONG FEMALES OF REPRODUCTIVE AGE GROUP - A RANDOMISED CONTROLLED STUDY INTRODUCTION - Polycystic Ovary Syndrome (PCOS) is one of the most prevalent endocrine system condition, adversely influences the fertility and reproductive health of women of reproductive age. Polycystic Ovary Syndrome is defined by a combination of signs and symptoms of androgen excess and ovarian dysfunction in the absence of other specific diagnoses (1,2). The World Health Organization (WHO) estimates Polycystic Ovary Syndrome affects 8 to13% of reproductive aged women globally, up to 70% of affected women remain undiagnosed worldwide. The prevalence rate of Polycystic Ovary Syndrome is high among Indian women, it ranges from 3.7 to 22.5%. One in every 10 women in India has polycystic ovarian syndrome, and out of every 10 women diagnosed with Polycystic Ovary Syndrome, six are teenage girls. (6) Background-Although Polycystic Ovary Syndrome can occur at any age, beginning with menarche, and the majority of instances are identified between the ages of 20 and 30years. Polycystic Ovary Syndrome is associated with a variety of long-term health problems that affect physical and emotional wellbeing. The exact cause of this multifactorial disorder is unknown, a combination of inherited and environmental factors is thought to play a primary role. (3, 4) This chronic and heterogeneous disorder manifests itself as menstrual dysfunction, infertility, hirsutism, acne, and obesity affecting 60-70% of people. Beyond physiological manifestations, polycystic ovary syndrome is associated with anxiety, depression, eating disorders, psychosexual dysfunction and negative body image, collectively contributing to diminished health-related quality of life in patients. Also, it increases the risk of related comorbidities such as type I diabetes &cardiovascular complications. (13) The treatment of Polycystic Ovary Syndrome is as complex as the disorder itself, since the clinical manifestation differs depending on the stage of life. During adolescence she may exhibit irregular menstruation, acne, hirsutism, or alopecia. During her reproductive years, she may present with obesity, acanthosis nigricans, infertility, or problems related to long-term PCOS sequelae, such as gynecological cancer, diabetes, or cardiovascular risk. (2,3) PURPOSE OF THE STUDY- Homoeopathy being holistic science, have immense scope in such complex endocrine disorder. Homoeopathy is known for its individualistic approach and holistic management of disease. The management of patient with Polycystic Ovary Syndrome will depend on the patient’s presenting complaints. As this complex entity presents with varied symptomatology this Holistic treatment modality can offer personalised treatment to every patient with polycystic ovary syndrome, hence it is an attempt to determine effectiveness of Individualised Homoeopathic medicines in management of Polycystic Ovary Syndrome among females of reproductive age group. Most of the studies were conducted either on single patient or small group of patients, to validate the result of small group studies, this larger sample size study is preferred. AIM: To study effectiveness of homoeopathy in polycystic ovary syndrome among female of reproductive age PRIMARY OBJECTIVES: To determine the effectiveness of Individualised Homoeopathic Medicines in management of Polycystic Ovary Syndrome among females of reproductive age. SECONDARY OBJECTIVES: To determine effectiveness of Individualised Homoeopathic Medicine in improving USG findings in Polycystic Ovary Syndrome among females of reproductive age. OTHER OBJECTIVES- 1. Review of polycystic ovary syndrome. 2. Review of homoeopathic Materia Medica for polycystic ovary syndrome. 3 To observe the menstrual cycle changes after medicinal intervention. |