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NOT YET RECRUITING
NCT07704944
PHASE1/PHASE2

Safety and Dose-Response of Bletilla Formosana in Prediabetic Subjects

Sponsor: Chang Gung Memorial Hospital

View on ClinicalTrials.gov

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

DRUG

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.

OTHER

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