Efficacy and Safety of Shatavari In Women with Polycystic Ovarian Disease Syndrome (PCOD): A Randomized, Double-Blind, Two-Arm, Placebo-Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Mean change in volume of ovaries and follicle count assessed on transvaginal ultrasound scan
研究概览
简要总结
· All eligible subjects who meet the Inclusion and Exclusion criteria will be part of the study.
· Subjects will be informed about the purpose of the study and signed informed consent will be taken.
· Blood sampling will be done at visit 1 (screening visit/ enrolment visit/ baseline visit- day 1) and visit 4 (Week 12).
· All subjects will be followed-up during the study period visit 1 (screening visit/ enrolment visit/ baseline visit- day 1), visit 2 (week 4) ± 4 days, visit 3 (Week 8) ± 4 days, and visit 4 (Week 12) ± 4 days.
· The Adverse events, either spontaneously reported by the patient, or noticed by the clinician will be recorded during the study
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 20.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- Female
入选标准
- •Women between 20-40 years of age.
- •2.Presence of ovarian volume of more than 10 cm3 in at last one ovary assessed by transvaginal ultrasound (US).
- •The presence of micro polycystic ovaries (more than or equal to 12 follicles per ovary) in at least one ovary assessed by transvaginal ultrasound (US).
- •No hormonal treatment in the 6 months prior the study.
- •LH/follicle-stimulating hormone (FSH) more than 2.
- •Absence of any adrenal and/or other endocrine disease.
- •Women willing to undergo transvaginal ultrasound (US) for ovarian assessment.
- •Women able to understand the study requirements and follow other procedures required by the study protocol.
- •Must have the ability and willingness to sign an informed consent and to comply with all study procedures.
排除标准
- 未提供
结局指标
主要结局
Mean change in volume of ovaries and follicle count assessed on transvaginal ultrasound scan
时间窗: Baseline, Week 8 and Week 12
次要结局
- Mean change in BMI(Baseline, Week 4, Week 8, Week 12)
- Mean change in laboratory parameters (HbA1C)(Baseline, Week 12)
- Mean change in lipid profile (total cholesterol, HDL cholesterol, LDL cholesterol and triglycerides)(Baseline, Week 12)
- Mean change in serum insulin by Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)(Baseline, Week 12)
- Mean change in serum hormones (Sr. Estradiol- E2, Follicle-Stimulating Hormone, Luteinizing Hormone, Progesterone, Testosterone, Dehydroepiandrosterone Sulfate)(Baseline, Week 12)
- Mean change in liver (serum alanine transaminase, aspartate transaminase, alkaline phosphatase, bilirubin) parameters(Baseline, Week 12)
- Mean change in renal (serum creatinine, blood urea nitrogen) parameters(Baseline, Week 12)
- Mean change in Thyroid (T3, T4, TSH) parameters(Baseline, Week 12)
- Mean change in perceived stress scale score(Baseline, Week 4, Week 8, Week 12)
- Proportion of patients experiencing Treatment-Emergent Adverse Events (TEAEs)(Baseline, Week 4, Week 8, Week 12)
- Proportion of patients experiencing Treatment-Emergent Serious Adverse Events (TESAEs)(Baseline, Week 4, Week 8, Week 12)
研究者
Dr Yashodhara Mhatre
Director