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Safety and Dose-Response of Bletilla Formosana in Prediabetic Subjects
Sponsor: Chang Gung Memorial Hospital
Summary
This study evaluates the safety and preliminary efficacy of Bletilla formosana (BF), a traditional herbal medicine, in adults with prediabetes. Prediabetes is a high-risk condition where blood sugar levels are elevated, often leading to type 2 diabetes. While lifestyle changes are the standard treatment, researchers are exploring herbal supplements as a complementary way to support metabolic health. Preclinical research has shown that BF possesses anti-inflammatory properties and may help regulate blood glucose. Participants in this study will be randomly assigned to receive either a high dose of BF, a low dose of BF, or a placebo (an inactive substance) for 12 weeks. The total study duration is approximately 24 weeks, involving four clinic visits for blood tests and safety monitoring to see how BF affects blood sugar markers and inflammation.
Official title: A Phase I/II Randomized, Double-Blind, Placebo-Controlled Pilot Trial Evaluating the Safety and Dose-Response of Bletilla Formosana in Prediabetic Subjects
Key Details
Gender
All
Age Range
30 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
94
Start Date
2026-07-01
Completion Date
2027-08-01
Last Updated
2026-07-15
Healthy Volunteers
No
Conditions
Interventions
Bletilla formosana (BF) powder
A traditional Chinese medicinal herb (Taiwanese ground orchid). The raw material is derived from the approved botanical species and medicinal part listed in the Taiwan Herbal Pharmacopoeia.
Placebo
An inactive powder matching the appearance and dosage form of the BF powder, consisting of starch and caramel coloring.
Locations (3)
Keelung Chang Gung Memorial Hospital
Keelung, Taiwan
Linkou Chang Gung Memorial Hospital
Taoyuan, Taiwan
Taoyuan Chang Gung Memorial Hospital
Taoyuan, Taiwan