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

NCT ID: NCT03142529

Last Updated: 2018-05-30

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-15
• Study Completion Date: 2018-10-15

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.

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.

Conditions

Chronic Kidney Failure; End-Stage Kidney Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Integrated Therapy

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

colon lotion

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

YZ20071408

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Guangdong Provincial Hospital of Traditional Chinese Medicine

OTHER

Sponsor Role: collaborator

Pang Peng

OTHER

Sponsor Role: lead

Responsible Party

Pang Peng

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Chen X Yin, Ph.D

Role: STUDY_CHAIR

Jinan University Guangzhou

Bao Kun

Role: STUDY_DIRECTOR

Guangdong Provincial Hospital of Traditional Chinese Medicine

Pang Peng

Role: PRINCIPAL_INVESTIGATOR

Jinan University Guangzhou

Locations

Guangdong Provincial Hospital of Traditional Chinese Medicine

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Pang Peng

Role: CONTACT

pangpeng@stu2014.jnu.edu.cn

01186-15099960366

Chen X Yin, Ph.D

Role: CONTACT

tchenxiaoyin@jnu.edu.cn

01186-13822263950

Facility Contacts

Kun Bao

Role: primary

baokun@aliyun.com

Other Identifiers

CRF-CD2017

Identifier Type: -

Identifier Source: org_study_id