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Clinical Trial Details

Trial ID: L2836
Source ID: NCT04623567
Associated Drug: Jiangtang Tiaozhi Recipe
Title: Efficacy Assessment of Chinese Herbal Medicine Jiangtang Tiaozhi Recipe Treating Participants With Glucose and Lipid Metabolism Disturbances
Acronym:
Status: RECRUITING
Study Results: NO
Results:
Conditions: Type2 Diabetes|Dyslipidemias
Interventions: DRUG: Jiangtang Tiaozhi recipe|DRUG: Metformin
Outcome Measures: Primary: Change from Baseline HbA1c at 12 weeks, 0 week, 12 weeks|Changes from Baseline Fasting Blood Glucose at 4 weeks, 8 weeks,12 weeks, 0 week, 4 weeks, 8 weeks,12 weeks|Change from Baseline Postprandial Blood Glucose at 12 weeks, 0 week, 12 weeks|Change from Baseline Low Density Lipoprotein at 12 weeks, 0 week, 12 weeks|Change from Baseline Triglyceride at 12 weeks, 0 week, 12 weeks | Secondary: Changes from Baseline Body Mass Index at 4 weeks, 8 weeks,12 weeks, 0 week, 4 weeks, 8 weeks,12 weeks|Changes from Baseline Waist Circumference at 4 weeks, 8 weeks,12 weeks, 0 week, 4 weeks, 8 weeks,12 weeks|Change from Baseline Total Cholesterol at 12 weeks, 0 week, 12 weeks|Change from Baseline High Density Lipoprotein at 12 weeks, 0 week, 12 weeks|Change from Baseline TCM Symptom Score at 12 weeks, 0 week, 12 weeks | Other: Compositional and Functional Changes from Baseline Gut Microbiota at 12 weeks, 0 week, 12 weeks|Compositional and Functional Changes from Baseline Metabolites in blood and feces at 12 weeks, 0 week, 12 weeks
Sponsor/Collaborators: Sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE1|PHASE2
Enrollment: 96
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2021-12-22
Completion Date: 2024-06-30
Results First Posted:
Last Update Posted: 2023-09-18
Locations: Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, Beijing, 100053, China
URL: https://clinicaltrials.gov/show/NCT04623567