Health Condition 1: E282- Polycystic ovarian syndrome
Conditions
Interventions
Intervention1: Majoon Dabidul Ward, Arq-e Mako and Arq-e Kasni: Majoon Dabidul Ward 6 gram twice daily, Arq-e Mako 60 mL twice daily and Arq-e Kasni 60 mL twice daily for 12 weeks
Control Intervention
Sponsors
Ajmal Khan Tibbiya College
Eligibility
Inclusion criteria
Inclusion criteria: Confirmed diagnosis of PCOS according to the Rotterdam Consensus Criteria (2003), requiring at least 2 of 3 criteria: HOMA-IR value 2.5 or more at baseline screening. Presence of oligomenorrhoea (cycle interval more 35 days or amenorrhoea (absence of menstruation for more than 90 days) for at least 6 months. Willing to provide written informed consent and comply with study protocol for the entire duration. Not on any hormonal contraceptives or insulin sensitisers for a minimum of 3 months prior to enrolment
Exclusion criteria
Exclusion criteria: Pregnancy or lactation Diagnosed thyroid disorders (TSH less than 0.5 or more than 5.0 mIUL), hyperprolactinaemia (prolactin more than 25 ngmL), or Congenital Adrenal Hyperplasia (CAH) Presence of severe hepatic dysfunction, renal impairment, or any systemic disease contraindicating study participation Known hypersensitivity to any ingredient of the study formulations. Concurrent participation in any other clinical trial. Body Mass Index (BMI) more than 40 kgm2. Current use of Metformin, OCP, anti-androgens therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in HOMA-IR from baseline to 12 weeks Calculated as Fasting Insulin (uIUmL) x Fasting Glucose (mmolL) per 22.5] Change in menstrual cycle frequency and regularity (assessed by validated menstrual diary and PALM-COEIN classification of AUB)Timepoint: baseline, 4 weeks, 8 weeks and 12 weeks and 16 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in HOMA-IR from baseline to 12 weeks Calculated as Fasting Insulin (uIUmL) x Fasting Glucose (mmolL) per 22.5] Change in menstrual cycle frequency and regularity (assessed by validated menstrual diary and PALM-COEIN classification of AUB)Timepoint: baseline, and 12 weeks | — |
Countries
India
Contacts
Public ContactFahmeeda Zeenat
Mahayogi Guru Gorakhnath Ayush University, Gorakhpur, UP
Outcome results
None listed