Effect of an Ayurvedic regimen in PCOS characterized by irregular periods associated with small cysts in the ovary and growth of facial hair in case of young girls
- Conditions
- Health Condition 1: null- Polycystic Ovary syndrome
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 60
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Attainment of normal menstrual cycle length (21-35days) <br/ ><br>change in body mass index(BMI)] as changes in hip waist measurement <br/ ><br>changes in size and no of ovarian follicle(by USG) <br/ ><br> <br/ ><br>Timepoint: Attainment of normal menstrual cycle length (21-35days) at the end of 6months <br/ ><br>change in body mass index(BMI)] as changes in hip waist measurement at 6 months <br/ ><br>changes in size and no of ovarian follicle(by USG) <br/ ><br>at the end of 6 months <br/ ><br>
- Secondary Outcome Measures
Name Time Method Changes in Metabolic parameters (i.e. blood sugar and lipid profile) <br/ ><br>Changes in hirsutism as per modified Ferriman-Gallwey (FG) Score <br/ ><br>Changes in Acne Score <br/ ><br>Changes in hormone level : Serum FSH, LH, Prolactin, Testosterone, Dehydroepiandrosterone sulphate (DHEAS), 17-Hydroxy-Progesterone (OHP), Insuline <br/ ><br>Improvement in quality of life by PCOSQTimepoint: Changes in Metabolic parameters <br/ ><br>Changes in hirsutism at base line, mid treatment and at the end of the treatment <br/ ><br>Changes in Acne Score Changes in hormone level : <br/ ><br>Improvement in quality of life by PCOSQ <br/ ><br> [Time frame: at base line on 90th day and at the end of the treatment i.e. 6 months] <br/ ><br>