Objective To explore the clinical effect and safety of Tianqi Jiangtang capsule combined with empagliflozin in the treatment of newly diagnosed type 2 diabetes mellitus (T2DM).

Method T2DM patients who received treatment at Hubei Provincial Directly Subordinate Hospital from January 2025 to December 2025 were enrolled as the research subjects. They were randomly divided into a treatment group and a control group using a random number table method. The control group received treatment with empagliflozin, while the treatment group received empagliflozin plus Tianqi Jiangtang capsule. Both groups were treated for 8 weeks. The clinical efficacy, traditional Chinese medicine syndrome score, blood glucose, insulin and pancreatic beta cell function, blood lipid levels, and adverse reactions between the two groups of patients were compared.

Results A total of 80 patients were included, with 40 patients in each group. After 8 weeks of treatment, the total effective rate of the treatment group was significantly, higher than that in the control group (90.00% vs. 72.50%, P<0.05), but the relative risk was 1.24 (95% CI: 0.99, 1.54), which was not statistically significant. The main symptoms, secondary symptoms, and overall score of the treatment group were lower than those of the control group (P<0.05); fasting blood glucose, glycated hemoglobin, and 2-hour postprandial blood glucose in the treatment group were lower than those in the control group (P<0.05); the 2-hour insulin and 2-hour C-peptide levels in the treatment group were higher than those in the control group (P<0.05); the total cholesterol, triglycerides, and low-density lipoprotein cholesterol in the treatment group were lower than those in the control group, while high-density lipoprotein cholesterol was higher than those in the control group (P<0.05). No adverse reactions were observed in either group.

Conclusion Compared with empagliflozin alone, the combination of Tianqi Jiangtang capsule and empagliflozin significantly reduces TCM syndrome scores and effectively improves insulin, C-peptide levels, and blood lipid levels. However, the superiority of the total effective rate remains uncertain, the clinical significance of blood glucose benefits is limited, and long-term safety needs to be further validated.

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