Righting Dispelling Turbid Liquid Renal Protection In Patients With Chronic Kidney Disease (ckd) Stage 3 Clinical Evaluation Research

Chronic Kidney Disease (CKD)have received much concern of the medical community for years, on account of its progression difficult to contain, symptoms complicated and complications seriously.The researches with good grounds and large samples all indicate that its incidence rate is more than10%.We have achieved some results in the researches of treating CKD by Traditional Chinese Medicine(TCM). But our researches were always be short of specification logical and systematical and scholarship conscientious.Making the results credibility and reference value lower.A clinical trial designed conformed to evidence-based medicine unadulteratedly will product some unimpeachable evidences for intervening the progression of CKD by TCM,as our will.Modern medicine had already have a standard of systematic treatment model and a system of curative effect evaluation,by regard improving the outcomes as target and controlling the primary affections, intervening the risk factors and treating complicating diseases.There is not a standard of treatment model most uniform, reasonable and effectual, by reason that the treatment concept of TCM, as treatment based on syndrome differentiation and hundreds schools of thought. Bui lding a system of curative effect evaluation of treat ing CKD by TCM or combined therapy of Chinese and Western medicine, on the bas is of modern medicine’s system is the most important thing of TCM’s nephrologists.Objective:This research is the first randomized controlled trial(RCT) used clinical endpoint and surrogate endpoint as the evaluation criterion of treating CKD by TCM. Intending to circumstantiate the protect effect of kidney of the combined therapeutic schedule of Chinese and Western medicine, and be a paragon for the clinical researches in this field.We wish make the effect of TCM in delaying the progression of CKD will earn the commonly agreed-upon specifications from internal and international nephrologists.Method:Select the patients conformed the standard diagnostic of CKD Level3in the clinic and ward of Guang’anmen Hospital and Fangshan Traditional Medical Hospital. After a4weeks washout period, run a randomized, prospective, single-blind, placebo-controlled trial in6weeks. Compare the treatment group(oral liquid of supporting Zheng and dispelling Zhuo, a TCM complex prescription to replenishing Qi, invigorating blood circulation, promoting diuresis and removing turbid pathogenic factors) with the placebo group (minimum dose group-10%treat dose) in following projects:the biological indicator as Scr and Hgb, the reduction in risk degree of the clinical endpoints (Renal replacement therapy, doubling of Scr and All-cause mortality), the effect on the surrogate endpoints (degraded level of GFR, rate of progressing to CKD level4, Elevated level of24hours urinary protein, the ime-varying rate of Scr——b value) and the assessment of the nutritional status and the security of treatment.Results:The treatment of CKD level3by oral liquid of supporting Zheng and dispelling Zhuo can efficiently decrease the level of Scr and Urinary albumin, improve GFR. The protect effect of kidney is unambiguous.The treatment can decrease the rate of progressing to CKD level4, increase the rate of regression to CKD level2, The protect and improve effect of renal function is unambiguous.The treatment can efficiently decrease the risk of the hospitalization related to CKD and the effect of G3a level is much better than G3b level.The treatment can efficiently improve the symptoms of TCM, the percentage of stabilization≥50%, the percentage of effectualness≥20%, and the effect of G3a level is much better than G3b level.The treatment can improve the malnutrition slightly,but the effect is not obvious.The treatment is safe and reliable.There is a possible protect effect of hepar.