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Clinical Trial Details

Trial ID: L6110
Source ID: NCT05095922
Associated Drug: Heart-Protecting Musk Pill
Title: Effect of HMP on Diabetic Microangiopaemia in T2DM
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 2|Diabetic Angiopathies
Interventions: DRUG: Heart-Protecting Musk Pill|DRUG: Valsartan Capsules|DRUG: Calcium Dobesilate Capsules
Outcome Measures: Primary: Concentration of biochemical Indicators, Total cholesterol(TC), Triglycerides(TG), High-density lipoprotein cholesterol(HDL-C), Low-density lipoprotein cholesterol(LDL-C), Fasting blood glucose(FBG), Blood urea nitrogen(BUN), Change from Baseline TC, TG, HDL-C, LDL-C, FBG, BUN at 3 months|Concentration of Glycosylated hemoglobin, Glycosylated hemoglobin(HbA1c), Change from Baseline HbA1c at 3 months|Concentration of hypersensitive-c-reactive-protein and Cystatin C, hypersensitive-c-reactive-protein(hs-CRP), Cystatin C(CysC), Change from Baseline hs-CRP and CysC at 3 months|Concentration of Serum creatinine, Serum creatinine(Scr), Change from Baseline Scr at 3 months|Rate of estimated Glomerular Filtration, estimated Glomerular Filtration Rate(eGFR), Change from Baseline eGFR at 3 months|Ratio of Urinary albumin to creatinine, Urinary albumin to creatinine Ratio(UACR), Change from Baseline UACR at 3 months|Concentration of Serum fatty acid binding protein 4, Serum fatty acid binding protein 4(FABP4), Change from Baseline FABP4 at 3 months|Indicators of diabetic retinopathy, The vision and fundus photography will be checked by an ophthalmologist to determine the effect., Change from Baseline effect at 3 months|Concentration of inflammation indicator, Tumor Necrosis Factor-α(TNF-α), Change from Baseline TNF-α at 3 months|Concentration of inflammation indicator, Vascular Endothelial Growth Factor(VEGF), Change from Baseline VEGF at 3 months|Concentration of inflammation indicator, CC chemokine ligand 3(CCL3), Change from Baseline CCL3 at 3 months|Concentration of Oxidative stress indicator, Superoxide dismutase(SOD), Change from Baseline SOD at 3 months|Concentration of Oxidative stress indicator, Glutathione peroxidase(GSH-Px), Change from Baseline GSH-Px at 3 months|Concentration of Oxidative stress indicator, Reactive oxygen species(ROS), Change from Baseline ROS at 3 months|Clinical characteristics, Height, Waistline, Change from Baseline Height, Waistline at 3 months|Clinical characteristic, Weight, Change from Baseline Weight at 3 months|Blood pressure, Systolic Blood Pressure(SBP), Diastolic Blood Pressure(DBP), Change from Baseline SBP, DBP at 3 months |
Sponsor/Collaborators: Sponsor: Affiliated Hospital of Nantong University
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 40
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2023-03-28
Completion Date: 2024-05-30
Results First Posted:
Last Update Posted: 2024-07-09
Locations: Affiliated Hospital of Nantong University, Nantong, Jiangsu, 226000, China
URL: https://clinicaltrials.gov/show/NCT05095922