Safety and Dose-Response of Bletilla Formosana in Prediabetic Subjects

ConditionPrediabetes

Trial statusNot yet recruiting

Trial phasePhase 1, Phase 2

Trial typeInterventional

Biological sexAll

Age30-70

SponsorChang Gung Memorial Hospital

About this trial

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.

Eligibility criteria

Qualifiers

Adults aged 30-70 years.

Fasting Plasma Glucose (FPG) of 100-125 mg/dL, or

Glycated hemoglobin (HbA1c) of 5.7%-6.4%.

Willingness to provide written informed consent and comply with study procedures.

Disqualifiers

Established type 1 or type 2 diabetes mellitus, or recent use of oral antidiabetic agents or insulin (within 3 months).

Abnormal liver function, defined as Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) exceeding 2-fold the upper reference limit (≥2 × ULN) at screening.

Abnormal renal function, defined as serum creatinine (Cr) >1.5 mg/dL or Estimated Glomerular Filtration Rate (eGFR) <60 mL/min/1.73 m².

Gastrointestinal disorders that may affect drug absorption, such as gastrostomy, enterostomy, severe chronic diarrhea, or malabsorption syndrome.

Trial design

Treatments tested in this trial

Bletilla formosana (BF) powder
Placebo

Treatment groups

94 Participants

are divided into 3 treatment groups

Sponsors and collaborators

Chang Gung Memorial Hospital

Lead sponsor

National Science and Technology Council

Collaborator

Source ClinicalTrials.gov