Clinical Trial: Integrative Medicine of IgA Nephropathy
Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional
Official Title: Treatment of Shentong Granules Plus Prednisone on Patients With Severe IgA Nephropathy(Ying-deficiency of the Liver and Kidney Pattern): a Randomized, Double-blind,Placebo
Brief Summary: The present study was designed to identify the efficacy and safety of Integrative Medicine by joint oral steroid medicine on liver-kidney yin deficiency, severe IgA nephropathy. Furthermore, search for potential diagnostic predictor in IgA Nephropathy by Proteomics and Metabolomics.
Detailed Summary: The present study was designed to identify the efficacy and safety of Integrative Medicine by joint oral steroid medicine on liver-kidney yin deficiency, severe IgA nephropathy. Furthermore, search for potential diagnostic predictor in IgA Nephropathy by Proteomics and Metabolomics. Combined with TCM Syndrome research, the investigators will clarify targets or mechanisms of herbal treatment. Eventually, to form a more clinically appropriate standardized combination treatment of severe IgA nephropathy.
Sponsor: Shanghai University of Traditional Chinese Medicine
Current Primary Outcome: Glomerular filtration rate [ Time Frame: changes from Baseline to 2, 4, 12, 24,36 and 48 weeks ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- 24-hour urinary protein excretion [ Time Frame: changes from Baseline to 2, 4, 12, 24,36 and 48 weeks ]
- serum creatinine [ Time Frame: changes from Baseline to 2, 4, 12, 24,36 and 48 weeks ]
- serum Lipid [ Time Frame: Half-yearly ]
- TCM syndrome score [ Time Frame: changes from Baseline to 2, 4, 12, 24,36 and 48 weeks ]
Original Secondary Outcome: Same as current
Information By: Shanghai University of Traditional Chinese Medicine
Dates:
Date Received: November 17, 2015
Date Started: June 2016
Date Completion: December 2017
Last Updated: March 17, 2016
Last Verified: November 2015
