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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ChiCTR |
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Last refreshed on:
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18 April 2017 |
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Main ID: |
ChiCTR-TRC-08000098 |
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Date of registration:
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2008-04-14 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Reseaech on integrated therapy of traditional Chinese medicine for membranous nephropathy
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Scientific title:
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Reseaech on integrated therapy of traditional Chinese medicine for membranous nephropathy |
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Date of first enrolment:
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2008-04-01 |
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Target sample size:
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Treatment group:95;Control group:95; |
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Recruitment status: |
Completed |
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URL:
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http://www.chictr.org.cn/showproj.aspx?proj=9427 |
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Study type:
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Interventional study |
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Study design:
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Randomized parallel controlled trial
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Phase:
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I (Phase I study)
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Countries of recruitment
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China
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Contacts
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Name:
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Yiping Chen, Yueyi Deng
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Address:
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No.725, Wanping South Road, Shanghai
200032
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Telephone:
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+86 0 13661791159 |
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Email:
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chenyplonghua@medmail.com.cn |
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Affiliation:
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Name:
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Yueyi Deng
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Address:
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No.725, Wanping South Road, Shanghai
200032
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Telephone:
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+86 021 28333352 |
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Email:
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dengyueyi@medmail.com.cn |
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Affiliation:
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Longhua Hospital Affiliated to Shanghai University of TCM |
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. The patient is diagnosed with idiopathic membranous nephropathy by renal biopsy;
2. Age 18~75years, without gender or nation restrict;
3. CKD <=Phase 3 (GFR>30ml/min), 24h urinary albumen >=3.5g.
Exclusion criteria: 1. Rapidly progressive membranous nephropathy;
2. Membranous nephropathy complicated with IgA nephropathy;
3. Medication of immunosuppressant and cytotoxic drugs are longer than 4 weeks in recent 6 months;
4. Intake of glucocorticoid is more than 20mg/d for more than 4 weeks in recent6years;
5. With serious complication such as severe infection;
6. Abnormality of HBV serum index and liver function;
7. Complicated with malignant tumor, HIV, psychosis, acute central nervous disease, severe gastrointestinal disease or contraindicated with immunosuppressant;
8. Abnormal of glycometabolism, fasting Blood-glucose> 6.2mmol/L;
9. Pregnant or breast-feeding women;
10. The patients have been participating in other researches;
11. Complicated with other sever organic and functional disorder;
12. With medication of traditional Chinese medicine in the past month;
13. Patients with hypertension should use other blood-pressure-lowering drugs except ACEI and ARB to control the blood pressure around 130/80mmHg, if the patient has taken ACEI& ARB, the medication should be suspended for 2 weeks.
Age minimum:
18
Age maximum:
75
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Idiopathic membranous nephropathy
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Intervention(s)
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Treatment group:Integrated therapy of TCM;Control group:Prednisone and CTX;
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Primary Outcome(s)
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24hours urinary albumin, creatine and serum albumi;Blood, stool and urine routine, liver function and ECG;Serum lipid, glomerular filtration rate, and renal biopsy;
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Secondary Outcome(s)
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Renal funtion and TCM symptoms and sign;
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Source(s) of Monetary Support
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The Ministry of Science and Technology of the People’s Republic of China
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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