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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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