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| Name | Class |
|---|---|
| Guangdong Provincial Hospital of Traditional Chinese Medicine | OTHER |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Integrated Therapy | No Intervention | This arm is an control group,in which participants will receive conventional integrated therapy on CRF. | |
| Integrated Therapy and colonic dialysis | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| colon lotion | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | the first day before intervention and the eleventh day |
| 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. | the first day before intervention and the eleventh day |
| Measure | Description | Time Frame |
|---|---|---|
| Change of serum electrolyte changes | measuring serum contents of sodium,potassium and phosphorus. | the first day before intervention and the eleventh day |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pang Peng | Contact | 01186-15099960366 | pangpeng@stu2014.jnu.edu.cn | |
| Chen X Yin, Ph.D | Contact | 01186-13822263950 | tchenxiaoyin@jnu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Chen X Yin, Ph.D | Jinan University Guangzhou | Study Chair |
| Bao Kun | Guangdong Provincial Hospital of Traditional Chinese Medicine | Study Director |
| Pang Peng |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangdong Provincial Hospital of Traditional Chinese Medicine | Recruiting | Guangzhou | Guangdong | 510006 | China |
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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| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| the first day before intervention and the eleventh day |
| Change of renal fibrosis index | measuring platelet derived growth factor (PDGF) secretion and serum transforming growth factor β(TGF-β). | the first day before intervention and the eleventh day |
| Jinan University Guangzhou |
| Principal Investigator |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |