Safety and Dose-Response of Bletilla Formosana in Prediabetic Subjects (NCT07704944) | Clinical Trial Compass
Not Yet RecruitingPhase 1/2
Safety and Dose-Response of Bletilla Formosana in Prediabetic Subjects
Taiwan94 participantsStarted 2026-07-01
Plain-language 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.
Who can participate
Age range
30 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Exclusion criteria
. Established type 1 or type 2 diabetes mellitus, or recent use of oral antidiabetic agents or insulin (within 3 months).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants with at Least One Treatment-Emergent Adverse Event (AE)
Timeframe: From baseline to Week 24.
2
Number of Participants with Serious Adverse Events (SAEs)
Timeframe: From baseline to Week 24
3
Change from Baseline in Fasting Plasma Glucose (FPG) (mg/dL)
Timeframe: Baseline, Week 6, Week 12, and Week 24.
4
Change from Baseline in Glycated Hemoglobin (HbA1c) (%)
Timeframe: Baseline, Week 6, Week 12, and Week 24.
5
Change from Baseline in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)
Timeframe: Baseline, Week 6, Week 12, and Week 24.
. 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.