A Comparative Clinical Study To Evaluate the Efficacy of Chandanadi vati And Bala Tail Matra Basti in the Management of Asrigdara W.S.R To Menorrahgia
试验速览
- 阶段
- 2 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 Chandanadi Vati with Bala Tail matra basti in the management of Asrigdara w.s.r. To Menorrahgia.
研究概览
简要总结
This is a randomised, comperative clinical study phase 2 parallel group trial.Comparing the efficacy of chandanadi vati and bala tail matra basti for 3 months in 40 patients.the patient fulfilling clinical criteria for diagnosis of asrigdara(menorrhagia) will be randomly selected from OPD/IPD of Department of Prasuti tantra evum stri roga State Ayurvedic College and Hospital Lucknow and reffered cases from other hospital.A carefully histoy physical examination and nessesary investigation will be performed. futher patient devided into 2 groups.
Group A - 20 Patients will be given the trial drug chandanadi vati 2BD (500mg each) will be given orally after meal with Tandulodak from 5th day of menstrual cycle to 1st day of next menstrual cycle with Bala taila (30 -60 ml) matra basti anter clearance of menses fon 3 consecutive cycle.
Group B - 20 patients of this group will be given the trial drug Bala tail matra basti after clearance of menses for 3 consecutive cycles.
Follow up - On the clearance of each mentrual cycle.
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 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •1.Patient having excessive, prolonged and intermenstrul bleeding.
- •2.Patient with age group of 20-45 years.
- •3.Patient Hb % more than 10 gm.
排除标准
- •1.Patient having uterine fibroid, uterine polyps, adenomyosis.
- •2.Malignant growth in uterus.
- •3.Patients considered having thyroid dysfunction, liver dysfunction, coagulation disorders etc.
- •4.Patient having systemic illness like diabetes, and hypertension etc.
- •5.Patient with IUCD and OCP.
- •6.Patient giving history of recent delivery or abortion.
结局指标
主要结局
1.To evaluate the efficacy of Chandanadi Vati with Bala Tail matra basti in the management of Asrigdara w.s.r. To Menorrahgia.
时间窗: 1.at 4 weeks | 2.at 4 weeks
2.To Compare the clinical efficacy of Chandanadi vati and Bala tail Matra basti in the management of Asrigdara w.s.r To Menorrhagia.
时间窗: 1.at 4 weeks | 2.at 4 weeks
次要结局
- 1.To study the critical review of ayurvedic & modern literature on Asrigdara w.s.r. To Menorrhagia.(2.To study the adverse effects of both the trial drug and procedure.)
研究者
Dr Sima Bharti
State Ayurvedic College And Hospital Tulsidas marg Turiyaganj Lucknow