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

Sponsor

Pang Peng (Other)

Overall Status

Unknown status

CT.gov ID

NCT03142529

Collaborator

Guangdong Provincial Hospital of Traditional Chinese Medicine (Other)

Enrollment

Location

Arms

Anticipated Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Kidney Failure End-Stage Kidney Disease	Drug: colon lotion	Phase 1/Phase 2

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

May 15, 2017

Anticipated Primary Completion Date :

Aug 15, 2018

Anticipated Study Completion Date :

Oct 15, 2018

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Integrated Therapy This arm is an control group,in which participants will receive conventional integrated therapy on CRF.
Experimental: Integrated Therapy and colonic dialysis 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 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. Other Names: YZ20071408

Arm

Intervention/Treatment

No Intervention: Integrated Therapy

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

Experimental: Integrated Therapy and colonic dialysis

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

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.

Other Names:

YZ20071408

Outcome Measures

Primary Outcome Measures

Change of glomerular filtration rate index [the first day before intervention and the eleventh day]
measuring the level of urea nitrogen，blood urea nitrogen,serum creatinine, serum cystatin C, blood and urineβ2-microglobulin. calculating the creatinine clearance rate.
Change of intestinal flora [the first day before intervention and the eleventh day]
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.

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Guangdong Provincial Hospital of Traditional Chinese Medicine	Guangzhou	Guangdong	China	510006

Sponsors and Collaborators

Pang Peng
Guangdong Provincial Hospital of Traditional Chinese Medicine

Investigators

Study Chair: Chen X Yin, Ph.D, Jinan University Guangzhou
Study Director: Bao Kun, Guangdong Provincial Hospital of Traditional Chinese Medicine
Principal Investigator: Pang Peng, Jinan University Guangzhou

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Pang Peng, Principal Investigator, Jinan University Guangzhou

ClinicalTrials.gov Identifier:

NCT03142529

Other Study ID Numbers:

CRF-CD2017

First Posted:

May 5, 2017

Last Update Posted:

May 30, 2018

Last Verified:

May 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by Pang Peng, Principal Investigator, Jinan University Guangzhou

Non dialysis

Additional relevant MeSH terms:

Kidney Diseases

Renal Insufficiency

Kidney Failure, Chronic

Study Results

No Results Posted as of May 30, 2018