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

Chronic Kidney Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03142529
• Other study ID #: CRF-CD2017
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: May 15, 2017
• Est. completion date: October 15, 2018

Study information

• Verified date: May 2018
• Source: Jinan University Guangzhou
• Contact: Pang Peng
• Phone: 01186-15099960366
• Email: pangpeng[@]stu2014.jnu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: October 15, 2018
• Est. primary completion date: August 15, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Kidney Failure
• End-Stage Kidney Disease
• Kidney Diseases
• Kidney Failure, Chronic
• Renal Insufficiency

Intervention

Drug:
• colon lotion
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.

Locations

Country	Name	City	State
China	Guangdong Provincial Hospital of Traditional Chinese Medicine	Guangzhou	Guangdong

Sponsors (2)

Lead Sponsor	Collaborator
Pang Peng	Guangdong Provincial Hospital of Traditional Chinese Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of glomerular filtration rate index	measuring the level of urea nitrogen,blood urea nitrogen,serum creatinine, serum cystatin C, blood and urineß2-microglobulin. calculating the creatinine clearance rate.	the first day before intervention and the eleventh day
Primary	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	Change of serum electrolyte changes	measuring serum contents of sodium,potassium and phosphorus.	the first day before intervention and the eleventh day
Secondary	Change of related inflammatory index	measuring hs-C reactive protein(hs-CRP),interleukin 1ß(IL-1ß),IL-6,tumor necrosis factor a(TNF-a) in serum.	the first day before intervention and the eleventh day
Secondary	Change of renal fibrosis index	measuring platelet derived growth factor (PDGF) secretion and serum transforming growth factor ß(TGF-ß).	the first day before intervention and the eleventh day