Health Condition 1: null- Polycystic Ovary syndrome
Conditions
Interventions
Intervention1: Rajahpravartini Vati-250 mg
Kanchanar Guggulu-500 mg and Varunadi Kashaya-20 mL: Rajapravartini Vati - 250 mg (1 tablet twice a day) orally with luke warm water after food
Kanc
Sponsors
Central Council for Research in Ayurvedic Sciences
Eligibility
Inclusion criteria
Inclusion criteria: Hyperandrogenism clinically (Hirsutism)/ or biochemically (elevated serum testosterone concentrations) Oligomenorrhea (cycles of 35 days or longer)/ Amenorrhea (no menses in the last 6 months) after negative screening pregnancy test Multiple cysts (more than 10) in the ovary Able to comply with the requirements of the study Able and willing to provide signed informed consent
Exclusion criteria
Exclusion criteria: Age-younger than 18 or older than 40 yr History of primary amenorrhea Secondary amenorrhea due to lactation Pregnancy/ Planned pregnancy during the treatment period Not associated with any organic reproductive system abnormalities (Excluded clinically and Radiological), pelvic inflammatory disease, Hydrosalpinx, endometriosis, adenomyosis, fibroid uterus, carcinoma of reproductive organ, etc. Current or previous (within the last 3 months) use of oral contraceptives, glucocorticoids, anti-androgens, ovulation induction agents, antidiabetic and anti-obesity drugs, or other hormonal drugs. Subjects with metabolic and endocrinal disorders like- diabetes mellitus, chronic Liver disease, renal disorder, high blood pressure, hypo & hyperthyroidism, etc. Ingestion of any investigational drugs within 4 weeks prior to study onset No uterine bleeding in progesterone challenge test
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Attainment of normal menstrual cycle length (21-35days) change in body mass index(BMI)] as changes in hip waist measurement changes in size and no of ovarian follicle(by USG) Timepoint: Attainment of normal menstrual cycle length (21-35days) at the end of 6months change in body mass index(BMI)] as changes in hip waist measurement at 6 months changes in size and no of ovarian follicle(by USG) at the end of 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in Metabolic parameters (i.e. blood sugar and lipid profile) Changes in hirsutism as per modified Ferriman-Gallwey (FG) Score Changes in Acne Score Changes in hormone level : Serum FSH, LH, Prolactin, Testosterone, Dehydroepiandrosterone sulphate (DHEAS), 17-Hydroxy-Progesterone (OHP), Insuline Improvement in quality of life by PCOSQTimepoint: Changes in Metabolic parameters Changes in hirsutism at base line, mid treatment and at the end of the treatment Changes in Acne Score Changes in hormone level : Improvement in quality of life by PCOSQ [Time frame: at base line on 90th day and at the end of the treatment i.e. 6 months] | — |
Countries
India
Contacts
Public ContactSusmita Priyadarshini Otta
Ayurveda Research Institute for Mother and Child Health Care
Outcome results
None listed