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临床试验/CTRI/2024/04/065576
CTRI/2024/04/065576尚未招募2 期

An open controlled clinical study to evaluate efficacy of Sariwadi Yoga in early diabetic kidney disease with special reference to microalbuminurea

not applicable1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2024年4月22日最近更新:

试验速览

阶段
2 期
状态
尚未招募
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

申办方类型
Other [not applicale]
责任方
Principal Investigator
主要研究者

Dr Arati Datye

R A PODAR medical college (Ayu) Worli Mumbai 18

研究点 (1)

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