ASSESSING THE ROLE OF INDIVIDUALIZED HOMOEOPATHIC MEDICINE IN TREATING THE SYMPTOMS OF ENDOMETRIOSIS USING MINTON’S UTERINE THERAPEUTICS – AN OPEN LABEL CLINICAL TRIAL
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- 1. Numeric Rating Scale
Study Overview
Brief Summary
Endometriosis is a condition where tissue similar to the lining of the uterus (the endometrial stroma and glands, which should only be located inside the uterus) is found elsewhere in the body. Endometriosis is an estrogen dependent disease thus usually effects women of reproductive age group, having 20-50% prevalence in infertile women but it can be as high as 71-87% in women with chronic pelvic pain. Homoeopathic literature has given generous attention to female heath issues & endometriosis though not directly mentioned in the texts, is being incorporated through the description of various manifesting symptoms relating to the menstrual state and thus individualized homoeopathic medicines plays a considerable role in treating endometriosis. Minton’s Uterine Therapeutics is a Regional Clinical Repertory which serves as a useful monograph on the problems of menstruation & other related functions. An open non-randomized single arm prospective clinical study is being taken up at the OPD of National Institute of Homoeopathy, Kolkata. West Bengal. 40 patients presenting with symptoms of Endometriosis with a positive finding in either USG/TVS and/Laparoscopy will be taken for the study. Outcome data will be assessed primarily through symptoms using Numeric Rating Scale (recorded at baseline and then every 4 weeks for 6 months) & RAND Item 36 Health Survey 1.0 (recorded at baseline and at 6 months). Changes in the outcome will be tested at baseline and at 6 months by statistical tests as appropriate. An attempt will be made to show changes in the pathology through lab investigations - USG/TVS and/Laparoscopy as a secondary outcome measure.
Study Design
- Study Type
- Interventional
- Allocation
- Not Applicable
- Masking
- Not Applicable
Eligibility Criteria
- Ages
- 18.00 Year(s) to 45.00 Year(s) (—)
- Sex
- Female
Inclusion Criteria
- •1.Female patient with a positive diagnostic finding for Endometriosis.
- •2.Reproductive age group (18-45 years) 3.Patients willing to give consent for participating in the study.
- •4.Patients who can read Bengali and/ Hindi and/English.
Exclusion Criteria
- •1.Pregnant women or lactating mothers.
- •2.Diagnosed cases of unstable psychiatric illness or other systemic disease affecting quality of life or some life threatening illness.
- •3.Patients not willing to participate in the study.
- •4.Substance abuse and/or dependence.
Outcomes
Primary Outcomes
1. Numeric Rating Scale
Time Frame: Baseline and six months
2. RAND Item 36 Health Survey 1.0 Questionnaire
Time Frame: Baseline and six months
Secondary Outcomes
- An attempt will be made to show changes in the pathology through lab investigations- USG/TVS and/laparoscopy(baseline to six months)