Effect of Thunbergia laurifolia Herbal Tea on Glucose Homeostasis in Healthy Volunteers: A Single-Arm Phase I Study

الملخص EN

Background.

Thunbergia laurifolia (TL) is a commonly used herbal medicine in Thailand and in other Asian countries.

TL has been approved as a Thai traditional medicine for detoxifying poisons, and the list of possible adverse effects includes hypoglycemia.

TL showed hypoglycemic effect in animals possibly due to antioxidant effect and beta-cell preservation.

However, the safety of TL herbal tea and its effects on glucose homeostasis have never been investigated in humans.

Methods.

Twenty healthy volunteers (10 men and 10 women) drank TL herbal tea 3 times/day for 2 weeks.

Ten subjects took TL herbal tea 9 grams daily.

After the safety of TL herbal tea was established, 10 more subjects took TL 12 grams daily.

Clinical and biochemical tests were assessed at baseline and at 2 weeks.

Results.

Mean age was 34.9 ± 10.2 years, and mean body mass index was 27.5 ± 5.8 kg/m2.

Baseline and posttreatment plasma concentrations were as follows: fasting plasma glucose (89 ± 6 vs.

89 ± 7 mg/dL), fructosamine (213 ± 32 vs.

212 ± 33 μmol/L), fasting insulin (8.8 [IQR: 5.9–18.4] vs.

10.4 [IQR: 7.4–15.2] μU/mL), HOMA-B (101.6 [IQR: 82.3–189.8] vs.

120.4 [IQR: 93.2–153.2]), and HOMA-IR (1.1 [IQR: 0.8–2.3] vs.

1.4 [IQR: 0.9–2.0]), all respectively.

There were no significant changes in these parameters, including body weight, blood pressure, lipid profile, and C-reactive protein.

No serious adverse events were observed during the study period.

Conclusions.

TL herbal tea at doses of 9 and 12 grams daily had good tolerability without any significant adverse effects on fasting plasma glucose level or other glucose homeostasis parameters measured.