An open label randomised comparative clinical trial to evaluate the efficacy of Priyangu Ghana Satva and Lajjalu Ghana Satva along with Sadyovirechan in the management of Asrigdara (Abnormal Uterine Bleeding O and E)
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Decrease in Amount of Blood Flow
研究概览
简要总结
Abnormal Uterine Bleeding is defined as bleeding from the uterine corpus which is abnormal in duration, volume, frequency and/or regularity. In Ayurveda, due to similarity in symptoms it can be correlated with Asrigdara which is defined as excessive or prolonged blood loss during menstruation with or without intermenstrual bleeding.To evaluate and compare the efficacy of Priyangu Ghana Satva and Lajjalu Ghana.Satva along with Sadyovirechan in normalization of menstrual flow.The trail will be performed in two groups consisting 30 in each group.One group will be given Priyangu Ghana Satva along with Sadyovirechana and the second group will receive Lajjalu Ghana Satva along with Sadyovirechana.The inclusion criteria is Subjects having confirm diagnosis of Asrigdara (Abnormal uterine bleeding O and E), Married and Unmarried Subjects of age group between 20 to 40 years who are willingto take part in the study Informed and written consent.Subjects presenting with at least one of the following features will be included in the study: Excessive Bleeding or Prolonged Bleeding and exclusion criteria is AUB P Polyp AUB A Adenomyosis AUB L Leiomyoma AUB M Malignancy AUB C Confirmed Coagulopathy AUB I Iatrogenic Cause Endometrial Hyperplasia ET more than 11 mm Bleeding due to cervical erosion CA cervix Bleeding following abortion Bleeding due to IUCD Bleeding from any site other than uterus PID Pregnancy Uncontrolled Hypothyroidism Hyperthyroidism Patient taking ATT Endometriosis Diabetes mellitus Hypertension Post-menopausal bleeding Hb less than 8gm. The primary expected outcome are decrease in Amount of Blood Flow and Decrease in Duration of Blood Flow.Secondary Expected Outcome are Reduction in Pain and Increase in Hb% by 1-2%
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 20.00 Year(s) 至 40.00 Year(s)(—)
- 性别
- Female
入选标准
- •Subjects having confirm diagnosis of Asrigdara (Abnormal uterine bleeding O and E) Married and Unmarried Subjects of age group between 20 to 40 years who are willing to take part in the study Informed and written consent.
- •Subjects presenting with at least one of the following features will be included in the study: Excessive Bleeding Prolonged Bleeding.
排除标准
- •AUB P Polyp AUB A Adenomyosis AUB L Leiomyoma AUB M Malignancy AUB C Confirmed Coagulopathy AUB I Iatrogenic Cause Endometrial Hyperplasia ET more than 11 mm Bleeding due to cervical erosion CA cervix Bleeding following abortion Bleeding due to IUCD Bleeding from any site other than uterus PID Pregnancy Uncontrolled Hypothyroidism Hyperthyroidism Patient taking ATT Endometriosis Diabetes mellitus Hypertension Post-menopausal bleeding Hb less than 8gm.
结局指标
主要结局
Decrease in Amount of Blood Flow
时间窗: from 0th to 90th day
Decrease in Duration of Blood Flow
时间窗: from 0th to 90th day
次要结局
- Reduction in Pain(Increase in Hb% by 1-2%)
研究者
Dr Anchal
Shri Dhanwnatry Ayurvedic college and Hospital Sector 46 b chandigarh 160047 India
