Safety and Dose-Response of Bletilla Formosana in Prediabetic Subjects

Starting soon · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Prediabetes

In brief

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.

Key facts

Study ID

NCT07704944

Run by

Chang Gung Memorial Hospital

People needed

94

Starts

2026-07-01

Expected to finish

2027-08-01

Last updated by the study team

2026-07-15

Who can join

Age: 30 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adults aged 30-70 years.
• Prediabetes defined by any of the following:
• 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.

You may not qualify if…

• 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.
• Severe comorbidities within the past 6 months, including major stroke, myocardial infarction, major trauma, or major surgery.
• Recent use of medications (within 1 month) that may significantly alter blood glucose or lipids, such as systemic corticosteroids or non-stable doses of lipid-lowering agents.
• Malignant tumor under active treatment, or immunodeficiency/autoimmune disorders requiring immunosuppressive therapy.
• Psychiatric disorders or cognitive impairment that may affect protocol compliance.
• Active use of other investigational drugs within 3 months prior to screening.
• Pregnancy or lactation.

Where it is running

• Keelung Chang Gung Memorial Hospital — Keelung, Taiwan
• Linkou Chang Gung Memorial Hospital — Taoyuan, Taiwan
• Taoyuan Chang Gung Memorial Hospital — Taoyuan, Taiwan

Full record on ClinicalTrials.gov

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