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Safety and Dose-Response of Bletilla Formosana in Prediabetic Subjects

14. juli 2026 oppdatert av: YUAN-CHIEH YEH, Chang Gung Memorial Hospital

A Phase I/II Randomized, Double-Blind, Placebo-Controlled Pilot Trial Evaluating the Safety and Dose-Response of Bletilla Formosana in Prediabetic Subjects

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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

This is a single-center, Phase I/II, randomized, double-blind, placebo-controlled, parallel-design trial. The primary goal is to translate robust preclinical findings-where BF extract was shown to inhibit neutrophil-driven inflammation and improve glycemic parameters in animal models-into clinical evidence.

A total of 94 prediabetic subjects (defined by FPG 100-125 mg/dL or HbA1c 5.7%-6.4%) will be enrolled.

Participants will be randomized in a 2:2:1 ratio into one of the following three arms:

High-dose group: 3g Bletilla formosana powder daily. Low-dose group: 1.5g Bletilla formosana powder plus 1.5g placebo daily. Placebo group: 3g inactive placebo powder daily.

The study consists of three distinct phases:

Screening Phase: Up to 2 weeks for eligibility confirmation. Treatment Phase: 12 weeks of oral administration. Follow-up Phase: 12 weeks post-treatment to evaluate sustained efficacy and safety outcomes.

Phase I objectives focus on safety and tolerability, with adverse events (AEs) and serious adverse events (SAEs) graded according to CTCAE v5.0.

Phase II objectives explore preliminary efficacy through changes in fasting plasma glucose (FPG), HbA1c, and HOMA-IR.

Secondary endpoints include assessment of inflammatory biomarkers (TNF-α, IL-6, and CRP) and lipid profiles.

Clinical assessments, including 12-lead ECG and comprehensive laboratory testing, are scheduled at Screening, Week 6, Week 12 (end of treatment), and Week 24 (end of study).

Studietype

Intervensjonell

Registrering (Antatt)

94

Fase

  • Fase 2
  • Fase 1

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

  • Taiwan
      • Keelung, Taiwan, 204
        • Keelung Chang Gung Memorial Hospital
        • Ta kontakt med:
        • Ta kontakt med:
        • Hovedetterforsker:
          • Yuan-Chieh Yeh, MD
      • Taoyuan, Taiwan, 333
        • Taoyuan Chang Gung Memorial Hospital
        • Ta kontakt med:
        • Ta kontakt med:
      • Taoyuan, Taiwan, 333
        • Linkou Chang Gung Memorial Hospital
        • Ta kontakt med:
        • Ta kontakt med:
        • Hovedetterforsker:
          • Hsing-Yu Chen, MD

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

Inclusion Criteria:

  1. Adults aged 30-70 years.
  2. Prediabetes defined by any of the following:
  3. Fasting Plasma Glucose (FPG) of 100-125 mg/dL, or
  4. Glycated hemoglobin (HbA1c) of 5.7%-6.4%.
  5. Willingness to provide written informed consent and comply with study procedures.

Exclusion Criteria:

  1. Established type 1 or type 2 diabetes mellitus, or recent use of oral antidiabetic agents or insulin (within 3 months).
  2. Abnormal liver function, defined as Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) exceeding 2-fold the upper reference limit (≥2 × ULN) at screening.
  3. Abnormal renal function, defined as serum creatinine (Cr) >1.5 mg/dL or Estimated Glomerular Filtration Rate (eGFR) <60 mL/min/1.73 m².
  4. Gastrointestinal disorders that may affect drug absorption, such as gastrostomy, enterostomy, severe chronic diarrhea, or malabsorption syndrome.
  5. Severe comorbidities within the past 6 months, including major stroke, myocardial infarction, major trauma, or major surgery.
  6. 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.
  7. Malignant tumor under active treatment, or immunodeficiency/autoimmune disorders requiring immunosuppressive therapy.
  8. Psychiatric disorders or cognitive impairment that may affect protocol compliance.
  9. Active use of other investigational drugs within 3 months prior to screening.
  10. Pregnancy or lactation.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Trippel

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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).
Legemiddel: Bletilla formosana (BF) powder
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.
Eksperimentell: 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).
Legemiddel: Bletilla formosana (BF) powder
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.
Annen: Placebo
An inactive powder matching the appearance and dosage form of the BF powder, consisting of starch and caramel coloring.
Placebo komparator: 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).
Annen: Placebo
An inactive powder matching the appearance and dosage form of the BF powder, consisting of starch and caramel coloring.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Number of Participants with at Least One Treatment-Emergent Adverse Event (AE)
Tidsramme: From baseline to Week 24.
Incidence of all adverse events (AEs) graded by CTCAE v5.0.
From baseline to Week 24.
Number of Participants with Serious Adverse Events (SAEs)
Tidsramme: From baseline to Week 24
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)
Tidsramme: Baseline, Week 6, Week 12, and Week 24.
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) (%)
Tidsramme: Baseline, Week 6, Week 12, and Week 24.
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)
Tidsramme: Baseline, Week 6, Week 12, and Week 24.
Calculated using fasting insulin and glucose levels to assess changes in insulin sensitivity.
Baseline, Week 6, Week 12, and Week 24.

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change from Baseline in Tumor Necrosis Factor-alpha (TNF-α) (pg/mL)
Tidsramme: Baseline, Week 6, Week 12, and Week 24.
To evaluate the anti-inflammatory effects of Bletilla formosana.
Baseline, Week 6, Week 12, and Week 24.
Change from Baseline in Interleukin-6 (IL-6) (pg/mL)
Tidsramme: Baseline, Week 6, Week 12, and Week 24.
To evaluate the anti-inflammatory effects of Bletilla formosana.
Baseline, Week 6, Week 12, and Week 24.
Change from Baseline in C-reactive protein (CRP) (mg/dL)
Tidsramme: Baseline, Week 6, Week 12, and Week 24.
To evaluate the anti-inflammatory effects of Bletilla formosana.
Baseline, Week 6, Week 12, and Week 24.
Change from Baseline in Total Cholesterol (mg/dL)
Tidsramme: Baseline, Week 6, Week 12, and Week 24.
Assessment of lipid profiles using standard laboratory methods
Baseline, Week 6, Week 12, and Week 24.
Change from Baseline in High-Density Lipoprotein (HDL) (mg/dL)
Tidsramme: Baseline, Week 6, Week 12, and Week 24.
Assessment of lipid profiles using standard laboratory methods.
Baseline, Week 6, Week 12, and Week 24.
Change from Baseline in Low-Density Lipoprotein (LDL) (mg/dL)
Tidsramme: Baseline, Week 6, Week 12, and Week 24.
Assessment of lipid profiles using standard laboratory methods.
Baseline, Week 6, Week 12, and Week 24.
Change from Baseline in Triglycerides (TG) (mg/dL)
Tidsramme: Baseline, Week 6, Week 12, and Week 24.
Assessment of lipid profiles using standard laboratory methods.
Baseline, Week 6, Week 12, and Week 24.

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change from Baseline in Alanine Aminotransferase (ALT) (U/L)
Tidsramme: Baseline, Week 6, Week 12, and Week 24.
Assessment of clinical laboratory safety tests to monitor hepatic, renal, and hematologic function.
Baseline, Week 6, Week 12, and Week 24.
Change from Baseline in Aspartate Aminotransferase (AST) (U/L)
Tidsramme: Baseline, Week 6, Week 12, and Week 24.
Assessment of clinical laboratory safety tests to monitor hepatic, renal, and hematologic function.
Baseline, Week 6, Week 12, and Week 24.
Change from Baseline in Total Bilirubin (mg/dL)
Tidsramme: Baseline, Week 6, Week 12, and Week 24.
Assessment of clinical laboratory safety tests to monitor hepatic, renal, and hematologic function.
Baseline, Week 6, Week 12, and Week 24.
Change from Baseline in Blood Urea Nitrogen (BUN) (mg/dL)
Tidsramme: Baseline, Week 6, Week 12, and Week 24.
Assessment of clinical laboratory safety tests to monitor hepatic, renal, and hematologic function.
Baseline, Week 6, Week 12, and Week 24.
Change from Baseline in Serum Creatinine (mg/dL)
Tidsramme: Baseline, Week 6, Week 12, and Week 24.
Assessment of clinical laboratory safety tests to monitor hepatic, renal, and hematologic function.
Baseline, Week 6, Week 12, and Week 24.
Change from Baseline in White Blood Cell Count (WBC) (10^3/μL)
Tidsramme: Baseline, Week 6, Week 12, and Week 24.
Assessment of clinical laboratory safety tests to monitor hepatic, renal, and hematologic function.
Baseline, Week 6, Week 12, and Week 24.
Change from Baseline in Hemoglobin (Hb) (g/dL)
Tidsramme: Baseline, Week 6, Week 12, and Week 24.
Assessment of clinical laboratory safety tests to monitor hepatic, renal, and hematologic function.
Baseline, Week 6, Week 12, and Week 24.
Change from Baseline in Platelet Count (10^3/μL)
Tidsramme: Baseline, Week 6, Week 12, and Week 24.
Assessment of clinical laboratory safety tests to monitor hepatic, renal, and hematologic function.
Baseline, Week 6, Week 12, and Week 24.

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Chang Gung Memorial Hospital

Samarbeidspartnere

National Science and Technology Council

Etterforskere

  • Hovedetterforsker: Yuan-Chieh Yeh, MD, Chang Gung Memorial Hospital

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. juli 2026

Primær fullføring (Antatt)

1. juli 2027

Studiet fullført (Antatt)

1. august 2027

Datoer for studieregistrering

Først innsendt

23. juni 2026

Først innsendt som oppfylte QC-kriteriene

14. juli 2026

Først lagt ut (Faktiske)

15. juli 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

15. juli 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

14. juli 2026

Sist bekreftet

1. juli 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 202500720A3C6002
  • NSTC 114-2321-B-255-001 (Annet stipend/finansieringsnummer: National Science and Technology Council)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

The study team does not have a plan to share individual participant data at this time to maintain participant confidentiality as stated in the informed consent.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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