An open label single arm clinical study of Eladi Kwatha with Sharkara and Madhu in Yonipravaha with special reference to Abnormal Uterine Bleeding
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- To study the efficacy of Eladi Kwatha with Sharkara and Madhu in
研究概览
简要总结
TITLE - An open label single arm clinical study of Eladi Kwatha with Sharkara and Madhu in Yonipravaha with special reference to abnormal uterine bleeding
Study design - an open label single arm clinical study
SAMPLE SIZE - 30
SAMPLING METHOD - Sequential Sampling
INCLUSION CLITERIA -Patients between the age group 15-45 yrs
Both married and unmarried women
Patients having Abnormal Uterine Bleeding with excessive and prolonged menstrual bleeding
EXCLUSION CLITERIA - Patients taking anti coagulation therapy and having any coagulation defect.
Patients with severe malnutrition and severe anemia (Hb ≤ 8 gm/dl).
Threatened, spontaneous or incomplete abortion/ectopic pregnancy,
trophoblastic diseases, placental abnormalities and Antepartum Hemorrhage.
Patients with systemic diseases like uncontrolled D.M. and T.B.
History of documented vascular disease like coronary artery disease,
cerebrovascular disease or stroke, transient ischemic attack, peripheral
vascular disease and DVT.
Condition like endometrial cancer of cervix, etc.
Bleeding from Reproductive Track due to traumatic causes, motor vehicle
accident and IC
WITHDRAWAL CLITERIA - Patients not willing for further trial.
-
If patient develops any adverse effect.
-
If bleeding increases during trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Open Label
入排标准
- 年龄范围
- 15.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •Patients between the age group 15-45 yrs Both married and unmarried women Patients having Abnormal Uterine Bleeding with excessive and prolonged menstrual bleeding.
排除标准
- •Patients taking anti coagulation therapy and having any coagulation defect.
- •Patients with severe malnutrition and severe anemia (Hb ≤ 8 gm/dl).
- •Threatened, spontaneous or incomplete abortion/ectopic pregnancy, trophoblastic diseases, placental abnormalities and Antepartum Hemorrhage.
- •Patients with systemic diseases like uncontrolled D.M. and T.B. History of documented vascular disease like coronary artery disease, cerebrovascular disease or stroke, transient ischemic attack, peripheral vascular disease and DVT.
- •Condition like endometrial cancer of cervix, etc.
- •Bleeding from Reproductive Track due to traumatic causes, motor vehicle accident and IC.
结局指标
主要结局
To study the efficacy of Eladi Kwatha with Sharkara and Madhu in
时间窗: day 1 to day 5 of Abnormal uterine bleeding
Yonipravaha.
时间窗: day 1 to day 5 of Abnormal uterine bleeding
次要结局
- Adverse effect of drug Eladi Kwatha with Sharkara and Madhu will be(observed during clinical study, if any.)