Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
140 participants
INTERVENTIONAL
2016-06-30
2017-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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WM Group
Shentong Granules, two packs, bid, P.O., 48weeks; Prednisone, 0.5-1mg/kg.d, P.O., eight to twelve weeks; then reduced to 30mg by reduce 5mg every two weeks; followed by the monthly reduction of 5mg, about 9-12 months
WM (Shentong Granules)
Shentong Granules with Prednisone
Hormone (prednisone)
Oral prednisone
Hormone Group
Placebo ; Prednisone, 0.5-1mg/kg.d, P.O., eight to twelve weeks; then reduced to 30mg by reduce 5mg every two weeks; followed by the monthly reduction of 5mg, about 9-12 months
Hormone (prednisone)
Oral prednisone
Interventions
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WM (Shentong Granules)
Shentong Granules with Prednisone
Hormone (prednisone)
Oral prednisone
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. TCM is liver kidney yin deficiency syndrome;
3. age 18-70 years old, sex, nationality is not limited;
4. CKD phase 2-4 （89 ml/min\>eGFR（EPI Formula）\>15ml/min/1.73m2）;
5. 24 hour urinary protein≥1g.
Exclusion Criteria
2. It had received corticosteroids (prednisone or prednisolone) within the past 3 months more than 20mg/d for more than up to 4 weeks;
3. Acute or progressive glomerulonephritis patients;
4. Severe complications threat to life, such as severe infection;
5. Active hepatitis B and liver function test sustained abnormal;
6. Patients with malignant tumor or have a history of cancer, HIV infection, history of mental illness, acute central nervous system diseases, severe gastrointestinal diseases, prohibition of the use of hormone;
7. Abnormal glucose metabolism, fasting blood glucose over 6.2mmol/L;
8. Gravid or lactation woman;
9. Other clinical trials are being studied;
10. Merger with other serious disease and dysfunction of the organ.
18 Years
70 Years
ALL
No
Sponsors
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RenJi Hospital
OTHER
Ruijin Hospital
OTHER
Shanghai 6th People's Hospital
OTHER
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
OTHER
Fudan University
OTHER
Shanghai University of Traditional Chinese Medicine
OTHER
Responsible Party
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Locations
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Department of Nephrology,Longhua Hospital
Shanghai, , China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ZY3- CCCX-2-1002
Identifier Type: -
Identifier Source: org_study_id
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