A clinical study to evaluate the EFFECT OF NAARIKELA PUSHPAADI KASHAYA IN ASRUGDARA (DYSFUNCTIONAL UTERINE BLEEDING)
试验速览
- 阶段
- Phase 3 4
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Assessment of symptoms such as excessive bleeding,prolonged bleeding,intermenstural bleeding,clotsAfter 2 months intervention (8 weeks)
研究概览
简要总结
It is an open label single arm clinical trial to evaluate the effect of Naarikela pushpaadi kashaya in Asrugdara ( Dysfunctional Uterine Bleeding).A minimum of 30 patients who are fulfilling the diagnostic and inclusion criteria will be selected from outpatient and inpatient department of prasuti tantra and striroga SDM college of Ayurveda and hospital Hassan.A screening form will be prepared with all aspects of history, signs and symptoms of Asrugdara and laboratory investigations to rule out major illnesses.During this process patients will be thoroughly screened for signs and symptoms of Asrugdara.Naarikela pushpaadi kashaya which is mentioned in sahasrayogam in the name of Thenginpookkuladi kashaya will be administered in the dose of 25 ml twice daily ,half an hour before food diluted with equal quantity of lukewarm water for two consecutive menstrual cycles.Required drugs will be collected from south India and authenticate after taxonomical identification and will be prepared in the teaching pharmacy of SDM college of Ayurveda and hospital.
研究设计
- 研究类型
- Interventional
- 分配方式
- Adaptive randomization, such as minimization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- Female
入选标准
- •Subject with menstral bleeding for more than 5 days in each cycle Patient using more than 3 completely soaked pads per day Intermenstrual bleeding Subjects with signs and symptoms of Asrugdara for at least 3 months.
排除标准
- •Known case of threatened or incomplete abortion Known case of coagulation and bleeding disorders Known case of thyroid dysfunction Known case of sexually transmitted diseases Using intra Uterine and oral contraceptives Known case of benign and malignant growth in uterus.
结局指标
主要结局
Assessment of symptoms such as excessive bleeding,prolonged bleeding,intermenstural bleeding,clotsAfter 2 months intervention (8 weeks)
时间窗: After 2 months intervention-1 month follow up
Assessment will be done.
时间窗: After 2 months intervention-1 month follow up
次要结局
- Attainment of Regular menstruation(3months)