Safety and Dose-Response of Bletilla Formosana in Prediabetic Subjects

NCT07704944 | Not Yet Recruiting Phase 1

• 2 other identifiers: 202500720A3C6002NSTC 114-2321-B-255-001
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Prediabetes

Keywords

Prediabetes; Bletilla formosana; Traditional Chinese Medicine; Herbal Medicine; Glycemic Control; Anti-inflammatory; Dose-Response Relationship; Phase I/II Trial; Randomized Controlled Trial; Safety and Tolerability

Outcome Measures

Primary Outcomes (5)

• Number of Participants with at Least One Treatment-Emergent Adverse Event (AE)

  Incidence of all adverse events (AEs) graded by CTCAE v5.0.

  From baseline to Week 24.

• Number of Participants with Serious Adverse Events (SAEs)

  Number of participants experiencing life-threatening or fatal events according to ICH-GCP definitions.

  From baseline to Week 24

• Change from Baseline in Fasting Plasma Glucose (FPG) (mg/dL)

  Change in fasting blood sugar levels to assess the preliminary glycemic efficacy of Bletilla formosana.

  Baseline, Week 6, Week 12, and Week 24.

• Change from Baseline in Glycated Hemoglobin (HbA1c) (%)

  Assessment of average blood glucose control over time.

  Baseline, Week 6, Week 12, and Week 24.

• Change from Baseline in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)

  Calculated using fasting insulin and glucose levels to assess changes in insulin sensitivity.

  Baseline, Week 6, Week 12, and Week 24.

Secondary Outcomes (7)

• Change from Baseline in Tumor Necrosis Factor-alpha (TNF-α) (pg/mL)

  Baseline, Week 6, Week 12, and Week 24.

• Change from Baseline in Interleukin-6 (IL-6) (pg/mL)

  Baseline, Week 6, Week 12, and Week 24.

• Change from Baseline in C-reactive protein (CRP) (mg/dL)

  Baseline, Week 6, Week 12, and Week 24.

• Change from Baseline in Total Cholesterol (mg/dL)

  Baseline, Week 6, Week 12, and Week 24.

• Change from Baseline in High-Density Lipoprotein (HDL) (mg/dL)

  Baseline, Week 6, Week 12, and Week 24.

Other Outcomes (8)

• Change from Baseline in Alanine Aminotransferase (ALT) (U/L)

  Baseline, Week 6, Week 12, and Week 24.

• Change from Baseline in Aspartate Aminotransferase (AST) (U/L)

  Baseline, Week 6, Week 12, and Week 24.

• Change from Baseline in Total Bilirubin (mg/dL)

  Baseline, Week 6, Week 12, and Week 24.

Study Arms (3)

High-dose Bletilla formosana (BF)

EXPERIMENTAL

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).

Drug: Bletilla formosana (BF) powder

Low-dose Bletilla formosana (BF)

EXPERIMENTAL

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).

Drug: Bletilla formosana (BF) powder; Other: Placebo

Placebo

PLACEBO COMPARATOR

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).

Other: Placebo

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.

High-dose Bletilla formosana (BF); Low-dose Bletilla formosana (BF)

Placebo OTHER

An inactive powder matching the appearance and dosage form of the BF powder, consisting of starch and caramel coloring.

Low-dose Bletilla formosana (BF); Placebo

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead
• National Science and Technology Council: collaborator

Study Sites (3)

Keelung Chang Gung Memorial Hospital

Keelung, 204, Taiwan

Location

Linkou Chang Gung Memorial Hospital

Taoyuan, 333, Taiwan

Location

Taoyuan Chang Gung Memorial Hospital

Taoyuan, 333, Taiwan

Location

MeSH Terms

Conditions

Prediabetic State

Interventions

Powders

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations

Study Officials

• Yuan-Chieh Yeh, MD

  Chang Gung Memorial Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yuan-Chieh Yeh, MD

CONTACT

+886-2-24313131; b9005030@cgmh.org.tw

Yu-Chieh Peng, Bachelor

CONTACT

+886-2-2431-2540; sunnypon1013@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: To ensure blinding, the investigational product (BF powder) and the placebo (starch with caramel coloring) are identically packaged in standardized, light-blocking plastic bottles and labeled only with unique subject codes. All participants receive the same number of sachets (one in the morning and one in the evening) so that the appearance, dosage form, and administration frequency remain indistinguishable across all treatment arms. The randomization code is securely maintained by the Traditional Chinese Medicine Pharmacy and will not be disclosed to investigators or participants until database lock.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor / Attending Physician

Model Details: This is a randomized, double-blind, 3-arm parallel trial. Participants are assigned in a 2:2:1 ratio to one of three groups: High-dose Bletilla formosana (BF), Low-dose BF, or Placebo. To maintain the blind, all participants follow an identical dosing schedule, taking one sachet in the morning and one sachet in the evening. The high-dose group receives two active BF sachets; the low-dose group receives one active BF sachet and one matching placebo sachet; and the placebo group receives two matching placebo sachets.

Study Record Dates

• First Submitted: June 23, 2026
• First Posted: July 15, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: July 15, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

TW (3)