Effect of herbal medicine compound promotes beta cell function among type 2 diabetes (T2D) adults: A randomized controlled clinical trial.

BACKGROUND

Herbal medicine as complementary ways are needed for patients who refuse to take medicine for life. Early intervention and lifestyle could delay the time of taking drugs.

OBJECTIVE

To assess the efficacy of Granules vs Sitagliptin in patients who diagnosed T2D.

METHODS

This is a randomized, double-blind trial. T2D patients were randomly assigned in a 1:1 ratio to Granules and Sitagliptin(50 mg), an anti-diabetic medicine group, for 12 weeks. Before randomization, the consenting participants were subjected to 2 weeks of screening, followed by twelve weeks of intervention. The primary outcome was change from baseline in glycosylated haemoglobin (HbA1C) and homeostasis model assessment-estimated insulin resistance (HOMA-IR) calculation at 12 week.

RESULTS

We recruited 103 patients, 84 patients participated in the clinical trial and finally 79 patients finished., the least square mean change in HbA1c and HOMA-IR from baseline was similar in both groups, in which HbA1c (6.93 ± 0.76,  = 0.007) and 2hPG (10.87 ± 2.20,  = 0.016) for the Control group, and HbA1c (6.76 ± 0.67,  < 0.001) and 2hPG (10.52 ± 2.46,  = 0.019).

CONCLUSIONS

This study revealed that the herbal medicine Xiaoke Granules provides effective glycaemic control with similar safety and immunogenicity profile to Sitagliptin among T2D patients treated for 12 weeks. This study strongly suggests further studies and utilization of Granules usage for controlling hyperglycemia among T2D patients.

TRIAL REGISTRATION

ClinicalTrials: ChiCTR1900026782.