Traditional Chinese Medicine (TCM) Colon Dialysis Treats Non-dialysis End-Stage Kidney Disease
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|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
|Condition or disease||Intervention/treatment||Phase|
|Chronic Kidney Failure End-Stage Kidney Disease||Drug: colon lotion||Phase 1 Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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
- 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.
- 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.
- Change of serum electrolyte changes [ Time Frame: the first day before intervention and the eleventh day ]measuring serum contents of sodium，potassium and phosphorus.
- 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.
- 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).
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
|Contact: Pang Pengemail@example.com|
|Contact: Chen X Yin, Ph.Dfirstname.lastname@example.org|
|Guangdong Provincial Hospital of Traditional Chinese Medicine||Recruiting|
|Guangzhou, Guangdong, China, 510006|
|Contact: Kun Bao email@example.com|
|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|