Evaluation of the Effectiveness of Individualized Homoeopathic Medicine on Menstrual Dysfunction in Hypothyroid Women through Hormonal Study of Gonadotrophins (FSH & LH): A Prospective, Open-Label Clinical Study.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 40
- Locations
- 1
Study Overview
Brief Summary
This interventional study aims to evaluate the effectiveness of individualized homoeopathic treatment in managing menstrual dysfunction among women with primary hypothyroidism. Menstrual irregularities assessed include amenorrhea, oligomenorrhoea, menorrhagia, metrorrhagia, and epimenorrhea. The study further examines changes in serum follicle-stimulating hormone and luteinizing hormone levels as objective biomarkers of hypothalamic pituitary ovarian axis regulation under homoeopathic therapy.
Pre and post treatment variations in thyroid profile parameters, including TSH T3 and T4 will also be analyzed to determine any associated improvement in endocrine function. Additionally the study explores the correlation between biochemical normalization and clinical improvement in menstrual patterns.
Due to the absence of prior interventional evidence in this area, the study proposes an initial sample size of 34 participants.
Inclusion criteria comprise women aged 18 to 45 years with biochemically confirmed primary hypothyroidism, stable on thyroxine therapy for more than 3 months, presenting with menstrual dysfunction and documented FSH and LH alterations measured between cycle days 2 to 5. Participants must provide voluntary written informed consent. Exclusion criteria include pregnancy or lactation, recent use of hormonal contraceptives, systemic or psychiatric illnesses substance abuse and known cases of PCOS with hyperandrogenism endometriosis dysfunctional uterine bleeding pelvic inflammatory disease bleeding disorders or structural uterine anomalies.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 45.00 Year(s) (—)
- Sex
- Female
Inclusion Criteria
- •1.Biochemically confirmed diagnosis of primary hypothyroidism with Elevated serum TSH with concurrently decreased levels of T4, in women presenting with menstrual dysfunction presenting as any of the following conditions like Amenorrhea, Oligomenorrhea, Menorrhagia, Metrorrhagia, or Epimenorrhea.
- •2.Females aged 18 to 45 years diagnosed with primary hypothyroidism, under stable thyroxine therapy for at least 3 months, presenting with documented menstrual irregularities.
- •3.Documented alterations in gonadotropin levels (FSH and or LH), measured between day 2 and day 5 of the menstrual cycle, based on standard laboratory reference ranges.
- •4.Willingness to participate, with voluntary written informed consent obtained prior to enrolment.
Exclusion Criteria
- •1.Current or recent (within past 3 months) use of oral hormonal contraceptives or hormone replacement therapy.
- •2.Pregnant or breastfeeding women.
- •3.Known cases of psychiatric disorders, autoimmune diseases, or serious systemic illnesses (e.g. malignancies, end stage organ failure).
- •4.Substance abuse or dependency, including alcohol or recreational drugs.
- •5.Known cases of PCOS with hyperandrogenism, endometriosis, DUB, pelvic inflammatory disease, bleeding disorders, or structural uterine anomalies.
Investigators
Dr Rathod Lavanya
National Institute of Homoeopathy