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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03142529
Recruitment Status : Unknown
Verified May 2018 by Pang Peng, Jinan University Guangzhou.
Recruitment status was:  Recruiting
First Posted : May 5, 2017
Last Update Posted : May 30, 2018
Sponsor:
Collaborator:
Guangdong Provincial Hospital of Traditional Chinese Medicine
Information provided by (Responsible Party):
Pang Peng, Jinan University Guangzhou

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Primary Completion Date : August 15, 2018
Estimated Study Completion Date : October 15, 2018

Resource links provided by the National Library of Medicine


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 Name: YZ20071408




Primary Outcome Measures :
  1. Change of glomerular filtration rate index [ Time Frame: 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.

  2. Change of intestinal flora [ Time Frame: 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 :
  1. Change of serum electrolyte changes [ Time Frame: the first day before intervention and the eleventh day ]
    measuring serum contents of sodium,potassium and phosphorus.

  2. Change of related inflammatory index [ Time Frame: 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.

  3. Change of renal fibrosis index [ Time Frame: the first day before intervention and the eleventh day ]
    measuring platelet derived growth factor (PDGF) secretion and serum transforming growth factor β(TGF-β).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03142529


Contacts
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Contact: Pang Peng 01186-15099960366 pangpeng@stu2014.jnu.edu.cn
Contact: Chen X Yin, Ph.D 01186-13822263950 tchenxiaoyin@jnu.edu.cn

Locations
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China, Guangdong
Guangdong Provincial Hospital of Traditional Chinese Medicine Recruiting
Guangzhou, Guangdong, China, 510006
Contact: Kun Bao       baokun@aliyun.com   
Sponsors and Collaborators
Pang Peng
Guangdong Provincial Hospital of Traditional Chinese Medicine
Investigators
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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
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Responsible Party: Pang Peng, Principal Investigator, Jinan University Guangzhou
ClinicalTrials.gov Identifier: NCT03142529    
Other Study ID Numbers: CRF-CD2017
First Posted: May 5, 2017    Key Record Dates
Last Update Posted: May 30, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Pang Peng, Jinan University Guangzhou:
Non dialysis
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency, Chronic