Safety and Dose-Response of Bletilla Formosana in Prediabetic Subjects

Sponsor
Chang Gung Memorial Hospital
Study ID
NCT07704944
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

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Conditions

  • Prediabetes

Eligibility Criteria

Sex
ALL
Age
30 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Bletilla formosana (BF) powder — DRUG
    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 — OTHER
    An inactive powder matching the appearance and dosage form of the BF powder, consisting of starch and caramel coloring.

Study Details

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 Dates

First listed
Jul 15, 2026
Start date
Jul 1, 2026
Status verified
Jul 2026
Primary completion
Jul 1, 2027
Completion
Aug 1, 2027

Study Design

Enrollment
94 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: High-dose Bletilla formosana (BF)
    Participants receive 3g of Bletilla formosana powder daily for 12 weeks. To maintain blinding, the total dose is divided into two 1.5g sachets (one in the morning and one in the evening).
  • Experimental: Low-dose Bletilla formosana (BF)
    Participants receive 1.5g of Bletilla formosana powder and 1.5g of placebo powder daily for 12 weeks. To maintain blinding, this is administered as one active sachet and one matching placebo sachet (one in the morning and one in the evening).
  • Placebo Comparator: Placebo
    Participants receive 3g of inactive placebo powder daily for 12 weeks. To maintain blinding, this is administered as two matching placebo sachets (one in the morning and one in the evening).

Primary Outcome Measure

Number of Participants with at Least One Treatment-Emergent Adverse Event (AE) [ Time Frame: From baseline to Week 24. ]

Central Contacts

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