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Clinical Trials/CTRI/2026/01/100169
CTRI/2026/01/100169Not yet recruitingPhase 2

Studying effectiveness of individualised homoeopathic medicine in the management of polycystic ovary syndrome among females of reproductive age group-A randomised controlled study.

Dr Aparna Kulkarni1 site in 1 country128 target enrollmentStarted: January 19, 2026Last updated:

Trial Snapshot

Phase
Phase 2
Status
Not yet recruiting
Sponsor
Enrollment
128
Locations
1
Primary Endpoint
USG changes and symptomatic relief in polycystic ovary syndrome cases

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
Participant Blinded

Eligibility Criteria

Ages
15.00 Year(s) to 49.00 Year(s) (—)
Sex
Female

Inclusion Criteria

  • clinical or biochemical hyperandrogenism evidence of oligomenorrhoea or anovulation ultrasonography findings of follicles with polycystic appearing in ovarian morphology.

Exclusion Criteria

  • diagnosed cases of other endocrinal disorders.

Outcomes

Primary Outcomes

USG changes and symptomatic relief in polycystic ovary syndrome cases

Time Frame: 1 year

Secondary Outcomes

  • menstrual regularity, reduced acne and hirsutism(1 year)

Investigators

Sponsor
Dr Aparna Kulkarni
Sponsor Class
Other [self]
Responsible Party
Principal Investigator
Principal Investigator

Aparna Kulkarni

Dhondumama Sathe Homoeoepathic Meddical College

Study Sites (1)

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