A Clinical Study to evaluate the efficacy of Balaguduchyadi Taila Matra Basti in Asrigdara.
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- 1.To evaluate the efficacy of Balaguduchyadi Taila Matra Basti in Asrigdara.
研究概览
简要总结
Any uterine bleeding outside the normal value, duration, regularity or frequency is AUB. Length of Rituchakra is lunar moon 28 days, normal menstrual interval is 21-35 days, duration of bleeding 3-5 days, amount is 50-80 ml. and change in any of the above parameters is known as Asrigdara. The word Asrigdara explains about prolonged, frequent or excessive menstrual bleeding in Ayurveda. The protocol in treating Asrigdara is to control the excessive bleeding and hence the drugs selected are of mainly madhura-tikta-kashaya rasa and sheeta virya which have Pitta shamaka and stambhaka properties. In our classical texts it is explained that Yoni rogas do not occur without vitiation of Vata, thus first of all Vata should be normalized. So the selected drug will be given in the form of Basti which will help in pacifying Vata Dosha. Keeping all this in mind, this study has been designed to work out the clinical evaluation of effectiveness of Balaguduchyadi Taila matra basti in Asrigdara. There will be two groups of 20-20 patients in which Group A patients will be treated with Balaguduchyadi Taila matra basti. Group B patients will be treated with Tab Tranexamic Acid for three consecutive menstrual cycles. Follow up will be done after every cycle during trial for 3 months. After completing trial of 3 months, patients will be reassessed again after every menstrual cycle for 3 months to check the efficacy of trial drug.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)(—)
- 性别
- Female
入选标准
- •Patients with either one or all symptoms of Asrigdara like Ritu Atipravitti (excessive bleeding during menstruation), Anritu pravritti (intermenstrual bleeding), Deergha Pravritti (prolonged bleeding).
- •Patients of reproductive, premenopausal age group.
排除标准
- •Disease beyond the inclusive criteria.
- •Patients with uterine and pelvic pathology like fibroid, Ca cervix, cervical polyp etc.
- •Patients using intrauterine contraceptive device.
- •Patient with cardiovascular disease.
- •Patients with renal disease.
- •Patient having bleeding phase more than 15 Days.
结局指标
主要结局
1.To evaluate the efficacy of Balaguduchyadi Taila Matra Basti in Asrigdara.
时间窗: Duration of treatment: It will be given for 3 months. | Follow up: It will be done after every cycle during treatment & after treatment reassessment will be done for 3 months after every cycle.
2.Improvement in Signs & Symptoms of patients.
时间窗: Duration of treatment: It will be given for 3 months. | Follow up: It will be done after every cycle during treatment & after treatment reassessment will be done for 3 months after every cycle.
3. Normalization of menstrual cycle.
时间窗: Duration of treatment: It will be given for 3 months. | Follow up: It will be done after every cycle during treatment & after treatment reassessment will be done for 3 months after every cycle.
次要结局
- 1. Detailed study of Asrigdara by both ancient & modern view.(2. To find out an Ayurvedic approach for the management of Asrigdara.)
