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Clinical Trial Details

Trial ID: L0107
Source ID: NCT05631782
Associated Drug: Shenkang Decoction
Title: Effects of Shenkang Decoction on Creatinine and Blood Urea Nitrogen in Chronic Renal Failure Hemodialysis Patients
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Chronic Renal Failure|Hemodialysis
Interventions: DRUG: Shenkang decoction
Outcome Measures: Primary: Renal function index, The AU5800 fully automatic biochemical analyzer produced by Beckman Coulter Co., Ltd. was selected for renal function index determination. peripheral venous blood (3-5 mL) was extracted before and after treatment, and Cre and urea nitrogen were measured after centrifugation, 8 min|TCM syndrome points, According to the relevant contents of the Clinical Guiding Principles of New Chinese Medicine13, clinical symptoms of shortness of breath, fatigue, anorexia, chills, abdominal fullness and distension, unsolid stool, and weak waist were evaluated., 14 days|Nutritional status index, In patients, 3 mL of fasting venous blood was collected and given anticoagulant treatment. The total serum protein, serum albumin, hemoglobin, and total red blood cells were measured by Mindray automatic biochemical analyzer (model BS-280, Shenzhen Mindray Bio-Medical Electronics Co., LTD.)., 14days|Dialysis adequacy judgment index, The urea dynamic model was used to evaluate the overall urea clearance judgment of a single dialysis effect, and Kt / V was calculated according to the Daugirdas formula. Kt / V= -ln (BUN before dialysis / BUN after dialysis-0.008 t) + (4-3.5 BUN before dialysis /BUN after dialysis) ultrafiltration volume / dialysis body weight. Long-term dialysis components are protein catabolism rate (calculated by Gotch formula) and time-average urea concentration (calculated by Lowrie formula). Protein catabolism rate = 9.35G×0.29Vt., 14 days|Treatment efficiency, The efficacy of the two groups was compared with the TCM syndrome points and the biochemical examination indexes., 14 days|General physical examination, Including heart rate, blood pressure, breathing, pulse, and urine volume. Urine routine, blood routine, stool routine, liver and kidney function testing, and electrocardiogram monitoring., 14 days |
Sponsor/Collaborators: Sponsor: The First People's Hospital of Zunyi
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: EARLY_PHASE1
Enrollment: 160
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2020-11-10
Completion Date: 2021-12-26
Results First Posted:
Last Update Posted: 2022-11-30
Locations: The First People's Hospital of Zunyi, Zunyi, China
URL: https://clinicaltrials.gov/show/NCT05631782