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

Pang Peng

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Chronic Kidney Failure; End-Stage Kidney Disease

Treatments: Drug: colon lotion

Study type: Interventional

Funder types: Other

Identifiers

NCT03142529

CRF-CD2017

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Integrated Therapy

No Intervention group

Description:

This arm is an control group,in which participants will receive conventional integrated therapy on CRF.

Integrated Therapy and colonic dialysis

Experimental group

Description:

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.

Treatment:

Drug: colon lotion