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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-12002228 |
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Date of registration:
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2012-02-03 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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The Clinical Study on the Dispelling Wind-dampness of IgA Nephropathy
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Scientific title:
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The Clinical Study on the Dispelling Wind-dampness of the chronic nephropathy: The Clinical Study on the Dispelling Wind-dampness of IgA Nephropathy(Multi-center, double-blind, randomized, controlled clinical trial program) |
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Date of first enrolment:
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2012-06-15 |
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Target sample size:
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Treatment group:114;Control group:114; |
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Recruitment status: |
Completed |
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URL:
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http://www.chictr.org.cn/showproj.aspx?proj=7322 |
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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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Other
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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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CHEN Hongyu
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Address:
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453 Tiyuchang Road, Hangzhou, China
310007
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Telephone:
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+86 0571 85827685 |
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Email:
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hzchenhy@126.com |
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Affiliation:
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Name:
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ZHANG Minou
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Address:
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453 Tiyuchang Road, Hangzhou, China
310007
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Telephone:
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+86 0571 85827635 |
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Email:
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zhangminou@yahoo.com.cn |
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Affiliation:
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hangzhou hospital of traditional chinese medicine |
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. person has signed the informed consent;
2. aged 16 to 65 years;
3. The renal biopsy diagnosed as IgA nephropathy and excluded patients with secondary renal;
4. 24h urinary protein >=0.5g; GFR (MDRD formula) >=30ml/min;
5. selected for the first 2 weeks of not using hormones or immunosuppressive therapy.
Exclusion criteria: 1. secondary IgA nephropathy;
2. pregnancy or pregnant and lactating women;
3. combined determination, brain, lung, liver, hematopoietic system, diabetes and other serious primary disease, or cancer, active tuberculosis in patients with wasting disease;
4. nearly two weeks, glucocorticoids, immunosuppressive therapy;
5. mental illness;
6. allergy against the drugs;
7. those who participate in other clinical drug trials;
8.examinations showed HBeAg or hepatitis B HBV-DNA> 103 copies/L;
9.To be not belong to Wind-dampness syndromes within the interference.
Age minimum:
16
Age maximum:
65
Gender:
Both
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Health Condition(s) or Problem(s) studied
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IgA Nephropathy
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Intervention(s)
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Treatment group:IgA nephropathy side (granules)+TWP tablet;Control group:Chinese medicine simulation granules + The Tripterygium simulation piece;
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Primary Outcome(s)
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renal pathology;Changes of TCM clinical syndrome score before and after treatment;GFR;proteinuria(Upro);urine erythrocyte;Serum creatinine;Serum albumin;Alanine aminotransferase, ALT;Urinary podocytes;Interleukin-6, IL-6;Tumor necrosis factor-alpha (TNF-alpha);Transforming growth factor-beta 1 (TGF-beta 1);
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Source(s) of Monetary Support
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Zhejiang Province major diseases of innovation platform of Traditional Chinese Medicine in science and technology
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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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