A study to compare the efficacy and adverse effects of metformin versus myoinositol plus d-chiroinositol combination therapy in polycystic ovarian syndrome

Not Applicable

Completed

Conditions: Polycystic ovarian syndrome,

Registration Number: CTRI/2019/03/018306

Lead Sponsor: Dr Sukhmani Jaura

Brief Summary: Polycystic ovarian syndrome is one of the most common endocrine disorders in women of reproductive age. The Rotterdam Criteria is to be fulfilled to diagnose the syndrome which requires the presence of two out of three conditions: Oligomenorrhea and/or anovulation, clinical and/or biochemical signs of hyperandrogenism that may be associated with hirsutism, and ultrasound findings showing polycystic ovaries. Hyperandrogenism is the cornerstone of the syndrome. Insulin resistance and resultant hyperinsulinaemia contribute to hyperandrogenism in these patients. Weight loss or pharmacologic interventions that lower insulin levels have shown to significantly reduce androgen levels and improve menstrual cycle patterns in many of these women. This study is planned specifically to evaluate the efficacy of metformin versus myoinositol plus d-chiroinositol combination therapy in PCOS patients and its subsequent effects on their clinical, hormonal and radiodiagnostic dimensions. The present study will be prospective, randomized parallel design interventional study for the duration of nine months. 50 newly diagnosed PCOS patients from the department of Obstetrics & Gynaecology, Government Medical College, Amritsar will be randomly divided into 2 groups, one group will be given Metformin 500 mg BD & other group Myoinositol plus d-chiroinositol combination therapy 1000 mg BD daily for 9 months. Follow up will be done at 3,6,9 months. At each visit, LH, FSH, AMH, testosterone, insulin, progesterone, estrogen and ultrasonic evidences will be evaluated.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Female

Target Recruitment: 50

Inclusion Criteria

Women fulfilling 2 out of 3 criteria of Rotterdam criteria Oligo menorrhea and/or Anovulation Clinical and/or hormonal parameters of hyperandrogenism that may be associated with Hirsutism Polycystic ovaries in ultrasound findings.

Exclusion Criteria

Women with pre-existing endocrine disorder History of Hypertension & Diabetes Mellitus Women who received previous treatment with other drugs within last 6 months Pregnancy.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the changes in the hormone levels of LH, FSH, AMH, testosterone, insulin, progesterone, estrogen and regularity of menstrual cycle after giving the interventional treatment.	3,6,9 months

Secondary Outcome Measures

Name	Time	Method
To evaluate the adverse effects of both treatments	3,6,9 months

Trial Locations

Locations (1): Government Medical College, Amritsar
🇮🇳
Amritsar, PUNJAB, India
Government Medical College, Amritsar
🇮🇳Amritsar, PUNJAB, India
Dr Sukhmani Jaura
Principal investigator
7696092106
sukhmaniamitoj29@gmail.com