Health Condition 1: E89-E89- Postprocedural endocrine and metabolic complications and disorders, not elsewhere classified
Conditions
Interventions
Intervention1: 1.ACARBOSE and METFORMIN
2.ACARBOSE and MYOINOSITOL: 1.ACARBOSE dose 25mg TID for 4 weeks, 50mg TID for 8 weeks, followed by 100mg TID for the rest of the treatment and METFORMIN dose 5
Sponsors
SRM College of Pharmacy SRM Institute of Science and Technology
Eligibility
Inclusion criteria
Inclusion criteria: a) Subjects diagnosed with PCOS based on Rotterdam criteria such as chronic anovulation- oligomenorrhea or amenorrhea, clinical or biochemical hyperandrogenism, polycystic ovarian morphology by transvaginal ultrasound. b) Subjects with IR ( fasting glucose: insulin ratio c) Subjects with aged 18 to 39 d) Subjects with BMI > 25 e) Subjects with willingness to provide informed consent will be included in the study.
Exclusion criteria
Exclusion criteria: a) Subjects with diseases and conditions that mimic PCOS such as Cushing syndrome, congenital adrenal hyperplasia, idiopathic hirsutism, prolactinoma, acromegaly, type 2 DM, ovarian and adrenal androgen secreting tumours. b) Subjects on Oral contraceptives, glucocorticoids, antiandrogen, ovulation induction tablets, anti-diabetes, anti-obesity drugs for the past 3 months will be excluded from the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Improvement in the Metabolic parameters such as TC, TGL, HDL-C, LDL-C, VLDL-C, Fasting Insulin, Fasting Glucose, QUICKI, HOMA-IR 2.Improvement in Hormonal parameters such as LH, FSH, LH: FSH, TT, SHBG, FAI, calculated free testosterone sr. progesterone 3.Regularization of Menstrual pattern. Timepoint: 1.Fasting blood samples such as Fasting Insulin, Fasting Glucose will be collected after an overnight fast of 12 hours . 2.Metabolic and Hormonal parameters will be collected at baseline and at every three months until the end of the study. 3. Anthropometric parameters such as BMI, Ht, Wt, Hip to Waist ratio will be collected at baseline and every month month through telephonic interviews | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Reduction in Hirsutism using modified ferriman gallwey score. 2.Reduction in Alopecia, Acne. 3.Improvement in Polycystic Ovarian Morphology. 4.Improvement in PCOS HRQoL. Timepoint: Hirsutism, acne, alopecia and PCOSQoL questionnaire will be assessed at baseline and at every 3 months until the end of the study. | — |
Countries
India
Contacts
Public ContactDr R Kamaraj
SRM Medical College Hospital and Research Centre
Outcome results
None listed