Efficacy and Safety of Chinese Herbal Medicine (T50) added to Metformin Monotherapy in Patients with Type 2 Diabetes Mellitus: A 12-week randomised, double-blind, placebo-controlled pilot clinical trial

Publication Type:
Thesis
Issue Date:
2024
Full metadata record
This clinical trial evaluated the efficacy and safety of T50, a traditional Chinese herbal formula, as an add-on treatment to metformin in individuals with type 2 diabetes mellitus (T2DM) who had insufficient blood glucose control. Forty-two participants with HbA1c levels between 7 to 9% and using metformin monotherapy were enrolled. They were randomized to receive either T50 or placebo over a 12-week period. The study’s primary goal was to assess changes in HbA1c level. Results showed a reduction in HbA1c in the T50 group compared to placebo. Additionally, T50 improved insulin resistance as indicated by a decrease in HOMA-IR scores, without affecting pancreatic β-cell function. No significant changes were observed in other metabolic indicators such as BMI or lipid levels. Liver and kidney functions remained stable. The treatment was well tolerated, with no serious side effects reported. These findings suggest that T50 may be a beneficial complementary therapy for improving glycaemic control in T2DM patients on metformin, although further large-scale and long-term studies are recommended.
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