An open controlled clinical study to evaluate efficacy of Sariwadi Yoga in early diabetic kidney disease with special reference to microalbuminurea
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Reduction in 24 hr urine microalbumin
研究概览
简要总结
Valid informed written consent will be taken in the language best understood by the patient
PLAN OF ACTION : Screening and selection of the patients will be carried out as per inclusion and exclusion criteria. -> Screening for selection criteria Included for Study Written Informed consent Randomization (Statistician provided random allocation) into 2 groups Group A = Study Group ,Group B =, Placebo group
Follow up every 30 days with Close observation of symptoms and AE if any Completion after 3 months
Statistical analysis with Appropriate test and Interpretation of Result
Treatment schedule : group A : standard care (OHA/Insulin, Statin, Anti hypertensive, RAS blockers)+ Saariwadi yoga
Group B : standard care + placebo drug (OHA/Insulin, Statin Anti hypertensive, RAS blockers Explanation for Insulin therapy in standard care
Trial Drug: Sariwadi Yoga 4 gm per day
control drug crystallline methyi cellulose
Drug will be dispenced to the patients for the period of three months free of cost
patients will be evaluated clinically every week
and laboratorical investigations will be done before screening an at the end of 3 monthsafter completion of study parametric data ( 24 hr urine micro albuminurea urine/creatinine ratio/sr creatinine ) will be analysed within the group and between the groups with students T test . and then conclusion will be drawn considering p value.p
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
- 18.00 Year(s) 至 70.00 Year(s)(—)
- 性别
- All
入选标准
- •k/c/o type 2 DM atleast since 6 monthd protienurea in the range 30-300 mcg/dl eGFR more than 45 ml/hr sr creatinineless than 2 mg/dl.
排除标准
- •uncontrolled DM and HTN renal diorders causing protienurea pregnancy and lactation mallignancy.
结局指标
主要结局
Reduction in 24 hr urine microalbumin
时间窗: Reduction in 24 hr urine microalbumin | reduction in albumin creatinine ratio | improvement in eGFR
reduction in albumin creatinine ratio
时间窗: Reduction in 24 hr urine microalbumin | reduction in albumin creatinine ratio | improvement in eGFR
improvement in eGFR
时间窗: Reduction in 24 hr urine microalbumin | reduction in albumin creatinine ratio | improvement in eGFR
次要结局
- change in symptoms like fatigue, edema(at the end of three months)
研究者
Dr Arati Datye
R A PODAR medical college (Ayu) Worli Mumbai 18
