Back to results

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

Primary Purpose

Chronic Kidney Failure, End-Stage Kidney Disease

Status

Unknown status

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

colon lotion

About this trial

This is an interventional treatment trial for Chronic Kidney Failure focused on measuring Non dialysis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Guangdong Provincial Hospital of Traditional Chinese MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Integrated Therapy

Integrated Therapy and colonic dialysis

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

Change of serum electrolyte changes

measuring serum contents of sodium，potassium and phosphorus.

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.

Change of renal fibrosis index

measuring platelet derived growth factor (PDGF) secretion and serum transforming growth factor β(TGF-β).

Full Information

NCT ID

NCT03142529

First Posted

April 20, 2017

Last Updated

May 28, 2018

Sponsor

Pang Peng

Collaborators

Guangdong Provincial Hospital of Traditional Chinese Medicine

1. Study Identification

Unique Protocol Identification Number

NCT03142529

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2018

Overall Recruitment Status

Unknown status

Study Start Date

May 15, 2017 (Actual)

Primary Completion Date

August 15, 2018 (Anticipated)

Study Completion Date

October 15, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Pang Peng

Collaborators

Guangdong Provincial Hospital of Traditional Chinese Medicine

4. Oversight

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.

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Kidney Failure, End-Stage Kidney Disease

Keywords

Non dialysis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Integrated Therapy

Arm Type

No Intervention

Arm Description

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

Arm Title

Integrated Therapy and colonic dialysis

Arm Type

Experimental

Arm 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.

Intervention Type

Drug

Intervention Name(s)

colon lotion

Other Intervention Name(s)

YZ20071408

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change of glomerular filtration rate index

Description

measuring the level of urea nitrogen，blood urea nitrogen,serum creatinine, serum cystatin C, blood and urineβ2-microglobulin. calculating the creatinine clearance rate.

Time Frame

the first day before intervention and the eleventh day

Title

Change of intestinal flora

Description

Time Frame

the first day before intervention and the eleventh day

Secondary Outcome Measure Information:

Title

Change of serum electrolyte changes

Description

measuring serum contents of sodium，potassium and phosphorus.

Time Frame

the first day before intervention and the eleventh day

Title

Change of related inflammatory index

Description

measuring hs-C reactive protein(hs-CRP),interleukin 1β(IL-1β)，IL-6，tumor necrosis factor α(TNF-α) in serum.

Time Frame

the first day before intervention and the eleventh day

Title

Change of renal fibrosis index

Description

measuring platelet derived growth factor (PDGF) secretion and serum transforming growth factor β(TGF-β).

Time Frame

the first day before intervention and the eleventh day

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Pang Peng

Phone

01186-15099960366

pangpeng@stu2014.jnu.edu.cn

First Name & Middle Initial & Last Name or Official Title & Degree

Chen X Yin, Ph.D

Phone

01186-13822263950

tchenxiaoyin@jnu.edu.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Chen X Yin, Ph.D

Organizational Affiliation

Jinan University Guangzhou

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Bao Kun

Organizational Affiliation

Guangdong Provincial Hospital of Traditional Chinese Medicine

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Pang Peng

Organizational Affiliation

Jinan University Guangzhou

Official's Role

Principal Investigator

Facility Information:

Facility Name

Guangdong Provincial Hospital of Traditional Chinese Medicine

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510006

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Kun Bao

baokun@aliyun.com

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Besides personal privacy information of the patients, all the other individual patient data（IPD）that treatment related will be shared with other researchers.After articles of this study publishing,researchers can obtain the information from the articles or sending e-mail to us.

Learn more about this trial

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

We'll reach out to this number within 24 hrs