Homoeopathic treatment of ovarian cysts

Phase 2

Completed

• Conditions: Health Condition 1: E282- Polycystic ovarian syndrome

• Registration Number: CTRI/2018/03/012573
• Lead Sponsor: ational Institute of Homoeopathy Ministry of AYUSH Govt of India

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2019-06-19
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 64

Inclusion Criteria

1. Diagnosed PCOS as per Rotterdam diagnostic criteria

2. Age 18-45 years

3. Symptomatic for at least last 3 months

4. Patients taking oral contraceptive pills (OCPs) will be advised to stop pills till it exhaust for the ongoing cycle, followed by re-assessment of symptoms in the next cycle enrolment

5. Patients under hormonal replacement therapy (HRT) to be included after a washout period of 3 months

6. Ability to read Bengali

8. Patients giving written consent to participate

Exclusion Criteria

1. Unevaluated gynaecological abnormalities; e.g. unexplained vaginal bleeding, cervical dysplasia, pelvic inflammatory diseases (PID) within one month, patients with suspicious adenomyosis, gross developmental defect or congenital abnormalities of the uterus etc.

2. Genito-urinary tract malignancy

3. Patients desiring immediate surgical management for PCOS

4. Patients insisting to use OCPs

5. Patients with psychiatric diseases

6. Pregnancy and lactation

7. Cases suffering from uncontrolled systemic illness or life-threatening infections or any vital organ failure

8. Cases already undergoing homoeopathic treatment for any chronic disease

9. Substance abuse and/or dependence

10. Self-reported immune-compromised state

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pelvic/transvaginal ultrasound and blood LH:FSH levelTimepoint: Baseline and after 6 months

Secondary Outcome Measures

Name	Time	Method
EQ-5D-5L questionnaire; validated Bengali versionTimepoint: Baseline, after 3 and 6 months;Modified PCOS questionnaire (MPCOSQ); translated Bengali versionTimepoint: Baseline, after 3 and 6 months