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Clinical Trial Details

Trial ID: L0928
Source ID: NCT01665651
Associated Drug: Yougui Granules
Title: Kidney Yin/Yang Replenishment on Patients With Renal Osteodystrophy
Acronym:
Status: WITHDRAWN
Study Results: NO
Results:
Conditions: Renal Insufficiency, Chronic|Renal Osteodystrophy
Interventions: DRUG: Yougui granules|DRUG: Zuogui granules|DRUG: Yougui granules placebo|DRUG: Zuogui granules placebo
Outcome Measures: Primary: Bone Mineral Density, 3 months | Secondary: Kidney Yin and Yang evaluation, Function of Kidney Yin and Yang will be evaluated with Traditional Chinese Medicine methods before and after treatment(Kidney Yin/Yang replenishment) to check whether function of Kidney Yin and Yang are improved. In Traditional Chinese Medicine, function of Kidney Yin and Yang are evaluated according to some specific symptoms and the severity including soreness of the waist and knee, exhausted, tinnitus, hard of hearing, hair loss, white hair, dizziness, dry mouth, red flush in face, night sweating, hot flashes, insomnia, dreaminess, the status of tongue body and coating and so on., 3 months|bone metabolism, bone alkaline phosphatase, fibroblast growth factor 23, Osteocalcin, Parathyroid hormone , 1,25(OH)2D3, serum and urinal Ca, P will be detected to check whether bone metabolism is improved after treatment(Kidney Yin/Yang replenishment)., 3 months|Blood Urea Nitrogen, BUN will be detected to check whether kidney function is improved after treatment(Kidney Yin/Yang replenishment), 3 months|creatinine, Creatinine will be detected to check whether kidney function is improved after treatment(Kidney Yin/Yang replenishment), 3 months | Other: miRNA array, 3 months|bone morphogenetic protein 7, 3 months
Sponsor/Collaborators: Sponsor: Bing Shu | Collaborators: Huadong Hospital|The First Affiliated Hospital of Anhui University of Chinese Medicine|Longhua Hospital
Gender: ALL
Age: ADULT
Phases: PHASE2
Enrollment: 0
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2012-08
Completion Date: 2017-05
Results First Posted:
Last Update Posted: 2017-05-08
Locations: The first affiliated hospital of Anhui University of TCM, Hefei, Anhui, 230031, China|Huadong hospital affiliated to Fudan University, Shanghai, Shanghai, 200000, China|Longhua Hospital affiliated to Shanghai Uni of TCM, Shanghai, Shanghai, 200032, China
URL: https://clinicaltrials.gov/show/NCT01665651