A RANDOMIZED, OPEN LABEL, PARALLEL GROUP CLINICAL STUDY TO EVALUATE THE EFFICACY AND SAFETY OF FEMIGARD GOLD IN UTERINE DISEASE CONDITIONS AND MENSTRUAL IRREGULARITIES
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- 1.Regularization of menstrual cycle and flow at the end of 12 weeks.
研究概览
简要总结
Forty five study Participants will be randomizedinto 3 groups with 15 patients in each group.
Group1: Patients with Menstrual irregularities(mild to moderate)with PCOS will receive Syp. Femigard gold 15 ml orally twice daily for 12 weeks.
Group2: Patients with Menstrualirregularities(mild to moderate) with Fibroid will receive Syp.Femigard gold 15 ml orally twice daily for 12 weeks.
Group3: Patients with Menstrualirregularities(mild to moderate) without any underlyingUterine pathology willreceive Syp. Femigard gold 15 ml orally twice daily for 12 weeks.
The outcome measures monitored are:
-
Regularization of menstrual cycleand flow at the end of 12 weeks.
-
Normalization or reduction of fibroid in group 2 - findings in ultrasonography(reduction in fibroid size) at the end of 12 weekscompared to baseline.
-
Hormonal assay (LH, FSH, Estradiol & Progesterone) at the end of 12 weeks treatment inPCOS patientsof group 1.
研究设计
- 研究类型
- Interventional
- 分配方式
- Random Number Table
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •1.Female participants with; i.Excessive menstrual bleeding ii.
- •Prolonged menstrual bleeding iii.
- •Presence of Blood clots in menstrual bleeding iv.
- •Irregular menstrual cycle vi.
- •USG report suggestive of PCOS (Polycystic ovarian syndrome) and Uterine fibroid for group 1 & 2 respectively.
- •Subjects with stable vitals like pulse and blood pressure
- •Patient should have not participated in any other clinical trial during the past 3 months.
- •Proper written informed consent obtained from the participants before any procedure is performed.
排除标准
- •Presence of any other Pelvic pathology
- •Presence of any other co morbid conditions like Diabetes mellitus and other cardiovascular complications.
- •Participants having IUCD(Intra uterine contraceptive device).
- •Presence of Thrombocytopenic purpura, Coagulopathy and any other bleeding complications.
- •Presence of severe Anemia (<6 gm%)
- •Hypothyroidism
- •Pregnant or lactating women and with history of recent abortion.
- •Hypersensitivity to any of the components of the formulation.
- •Vulnerable population such as TB affected individuals, HIV and HBsAg positive patients.
- •Presence of any other condition that leads the investigator to conclude that the patient is inappropriate for inclusion in this clinical study.
结局指标
主要结局
1.Regularization of menstrual cycle and flow at the end of 12 weeks.
时间窗: baseline and end of 12 weeks
2. Normalization or reduction of fibroid in group 2 - findings in ultrasonography (reduction in fibroid size) at the end of 12 weeks compared to baseline.
时间窗: baseline and end of 12 weeks
3. Hormonal assay (LH, FSH, Estradiol & Progesterone) at the end of 12 weeks treatment in PCOS patients of group 1.
时间窗: baseline and end of 12 weeks
次要结局
- To monitor for any adverse events during the study period([At end of 12 weeks (post study) of the study period, Complete blood count and Biochemical parameters will be repeated to assess the safety of the participants] and)