A Double Blind Randomized Placebo Controlled Pilot Study Evaluating The Efficacy Of Imeglimin In Patients With Polycystic Ovarian Syndrome
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Insulin resistance using insulin resistance parameters like C-peptide, Homeostatic Model Assessment for insulin resistance (HOMO-IR)
研究概览
简要总结
A Double Blind Randomized Placebo Controlled Pilot Study Evaluating The Efficacy Of Imeglimin In Patients With Polycystic Ovarian Syndrome with BMI more than 25mg/kg2 . For the study, A total of 100 patients are taken. They will be equally divided into two groups .One group will receive Metformin 500mg OD with placebo for 6months and other group will receive Metformin 500mg OD with imeglimin 500mg OD for 6months .The primary outcome measures****Insulin resistance using insulin resistance parameters like C-peptide, Homeostatic Model Assessment for
insulin resistance**(HOMO-IR).**
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- Female
入选标准
- •Polycystic ovarian syndrome diagnosed patient with BMI ≥ 25 kg/m2 -Patients willing to give informed consent.
排除标准
- •History of allergic reactions attributed to compounds of similar chemical or biologic composition of metformin or imeglimin -Patients with history renal dysfunction (documented in biochemical test), acute / chronic metabolic acidosis, congestive cardiac failure needing drug treatment, lactic acidosis -Patients on drug known to have significant drug-drug interactions either metformin or imeglimin -Pregnant females.
结局指标
主要结局
Insulin resistance using insulin resistance parameters like C-peptide, Homeostatic Model Assessment for insulin resistance (HOMO-IR)
时间窗: Two years
次要结局
- - Hyperandrogenism using S.Testosterone(- Inflammation using AGEs, MDA,CRP)
研究者
Dr. Riya Sharma
Jawaharlal Nehru Medical College Aligarh Muslim University