Traditional Chinese Medicine (TCM) Colon Dialysis Treats Non-dialysis End-Stage Kidney Disease

Study Overview
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Brief Summary
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This study evaluates the clinical efficacy and study the therapeutic mechanism of a kind of traditional Chinese medicine colonic dialysis on Chronic kidney disease (CKD) 5 without blood dialysis therapy in adults. Half of participants will receive conventional integrated therapy on chronic renal failure (CRF), while the other half will receive integrated therapy on CRF and traditional Chinese medicine colonic dialysis.

Detailed Description
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Patients who would hospitalized in Nephrology of Guangdong Provincial Hospital of Traditional Chinese Medicine have chance to participate this study. All participates will be divided into two groups depending on their individual treatment interests and the baseline information will be balanced. Integrated Therapy is routine symptomatic and supportive treatment for CRF,including reducing blood pressure and urine protein, improving anemia，regulating calcium and phosphorus metabolism and so on.The colon lotion used in colonic dialysis is a kind of hospital preparation. It consists of Rhubarb, Concha ostreae and some other traditional Chinese medicine.The whole treatment lasts about 10 days,as long as a regular drill-and-fill procedure. Before and after the treatment, related body dimensions will be tested.

Official Title
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Clinical Observation of Therapeutic Effects on Traditional Chinese Medicine Colon Dialysis Treating Non-dialysis End-Stage Kidney Disease

Conditions
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Chronic Kidney Failure, End-Stage Kidney Disease

Intervention / Treatment
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* Drug: colon lotion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1.corresponding to diagnosis standards of CKD-5:eGFR≤15ml/min/1.73m2; 2. did not receive kidney replacement therapy; 3. no gastrointestinal diseases (including ulcerative colitis, irritable bowel syndrome, inflammation, cancer, infection, bleeding, etc.) in the past 1 year; 4.not associated with rectal-related disorders (hemorrhoids, anal fistula, rectal cancer, cancer, infection, bleeding, etc.); 5.Sign informed consent. Exclusion Criteria: 1. having used antibiotics, hormones, immunosuppressive, probiotics and laxatives in past three months; 2. pregnant or lactating patients; 3.cannot cooperate or tolerate colonic dialysis treatment; 4.combined with active stage of malignant tumors, cardiovascular, respiratory system, decompensated liver cirrhosis or blood system diseases (including coagulation disorders, hematopoietic dysfunction, etc.) and other serious primary disease; 5. recent merger of patients with infectious diseases; 6.having known to be allergic to some drugs in the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Integrated Therapy<br>This arm is an control group,in which participants will receive conventional integrated therapy on CRF. | |
| Experimental: Integrated Therapy and colonic dialysis<br>This arm is a treatment group,in which participants will receive integrated therapy on CRF and traditional Chinese medicine Colonic dialysis with traditional Chinese medicine colon lotion once a day. | Drug: colon lotion<br>* The colon lotion used in this clinic trial is a kind of hospital preparation. It is brown liquid,which consists of Rhubarb, Concha ostreae and some other traditional Chinese medicine.The colon lotion is diluted from 30ml to 150ml each time and will be used once a day for 10 days.<br>* Other names: YZ20071408;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of glomerular filtration rate index | measuring the level of urea nitrogen，blood urea nitrogen,serum creatinine, serum cystatin C, blood and urineβ2-microglobulin. calculating the creatinine clearance rate. | the first day before intervention and the eleventh day | 
| Change of intestinal flora | measuring serum endotoxin and investigating the differences of intestinal flora between control group and experience group，as well as the differences between before colonic dialysis and after colonic dialysis. | the first day before intervention and the eleventh day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of serum electrolyte changes | measuring serum contents of sodium，potassium and phosphorus. | the first day before intervention and the eleventh day | 
| Change of related inflammatory index | measuring hs-C reactive protein(hs-CRP),interleukin 1β(IL-1β)，IL-6，tumor necrosis factor α(TNF-α) in serum. | the first day before intervention and the eleventh day | 
| Change of renal fibrosis index | measuring platelet derived growth factor (PDGF) secretion and serum transforming growth factor β(TGF-β). | the first day before intervention and the eleventh day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Non dialysis