drugset / Trial / NCT06450652

CHM for T2DM & MetS

NCT06450652

Unknown 15 enrolled Hong Kong Baptist University
NaSingle-groupOpen-labelTreatment

Summary

This is a single-arm design. A total of 15 Type 2 Diabetes Mellitus (T2DM) patients with comorbid Metabolic Syndrome (MetS) will be recruited from community. The intervention will be a 4-week of Chinese Herbal Medicine granules treatment, which will consist of six Chinese herbs. The primary outcome measure will be fasting plasma glucose and blood pressure. Secondary outcome measures including changes of anthropometric data (body mass index, waist-to-hip ratio), lipid panels (total cholesterol, triglycerides, high-density lipoprotein, low-density lipoprotein), HbA1C, Framingham Stroke Risk Score (FSRS), Audit of diabetes-dependent quality of Life (ADDQoL), International Physical Activity Questionnaire Short Form (IPAQ-SF), daily step count and physiological parameters from wearable watch, dietary record, retinal and sublingual vein imaging, concurrent medications and adverse events.

Timeline

Start
2024-06
Primary completion
2024-09
Completion
2024-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Chinese Herbal Medicine granules Traditional medicine (herbal / TCM) Oral