CTRI/2023/10/058242尚未招募2/3 期
A comparative clinical study of Gokshuradi Guggulu and Renogrit in Chronic Kidney Disease
Patanjali Bhartiya Ayurvigyan Evum Anusandhan Sansthan1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2023年10月13日最近更新:
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
- subejctive criteria-
研究概览
简要总结
This is an open label double arm comparative clinical study , comparing the efficacy of Gokshuradi Guggulu 500 mg 2 Tablets twice daily before meals and Renogrit tablet 540 mg each 2 tablets twice daily before meals for 18 months in 40 patients of Chronic Kidney Disease that will be conducted in OPD no. 13/14 at Patanjali Ayurveda hospital, Haridwar
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 16.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •.Clinically stable patients of stage 1, 2 as per K/DOQI guidelines 2.Creatinine level i.e., between 1.5 mg/dl to 5 mg/dl.
- •3.Blood urea levels between- 50 to 130 mg/dl 4.Patients of either gender between the age group of 16 to 70 years of age.
排除标准
- •1.Associated complications like respiratory distress, Anuria, oliguria, cardiovascular complications.
- •2.Patients Requiring dialysis and renal transplant.
- •3.Patients with Malignant hypertension, Uncontrolled Diabetic patients, SLE.
- •Pregnant, lactating Women.
结局指标
主要结局
subejctive criteria-
时间窗: 0 day 30th day 60th day
2.nausea
时间窗: 0 day 30th day 60th day
1.pedal edema
时间窗: 0 day 30th day 60th day
3.anorexia
时间窗: 0 day 30th day 60th day
4.vomiting
时间窗: 0 day 30th day 60th day
5.Breathlessness
时间窗: 0 day 30th day 60th day
6.tiredness
时间窗: 0 day 30th day 60th day
次要结局
- Objective criteria(1 Hb)
研究者
研究点 (1)
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