PrediabetesPhase 1/2NCT07704944
Safety and Dose-Response of Bletilla Formosana in Prediabetic Subjects
A Phase 1/2 study testing Bletilla formosana (BF) powder in people with Prediabetes, run by Chang Gung Memorial Hospital at 3 sites in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Prediabetes
- What is being tested?
- Bletilla formosana (BF) powder
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 94 participants
- Where
- 3 sitesTaiwan
- Study dates
- 1 Jul 2026to 1 Aug 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan3 sites
Keelung Chang Gung Memorial Hospital
Keelung, 204
Yuan-Chieh Yeh, MD, +886-2-24313131 ext. 6320, b9005030@gmail.com
Yu-Chieh Peng, Bachelor, +886-2-2431-2540, sunnypon1013@gmail.com
Linkou Chang Gung Memorial Hospital
Taoyuan, 333
Hsing-Yu Chen, MD, +886-975366119, 8705016@cgmh.org.tw
Yu-Chieh Peng, Bachelor, +886-2-2431-2540, sunnypon1013@gmail.com
Taoyuan Chang Gung Memorial Hospital
Taoyuan, 333
Hsing-Yu Chen, MD, +886-975366119, 8705016@cgmh.org.tw
Yu-Chieh Peng, Bachelor, +886-2-2431-2540, sunnypon1013@gmail.com
About this study
Official title: 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.
Read the detailed description
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).
- Conditions
- Prediabetes
- Being tested
- Bletilla formosana (BF) powder, Placebo
- 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
- Medical subject headings
- Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bletilla formosana (BF) powderDrug
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.
PlaceboOther
An inactive powder matching the appearance and dosage form of the BF powder, consisting of starch and caramel coloring.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: 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). Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with at Least One Treatment-Emergent Adverse Event (AE)
Incidence of all adverse events (AEs) graded by CTCAE v5.0.
Measured: 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.
Measured: 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.
Measured: Baseline, Week 6, Week 12, and Week 24.
Change from Baseline in Glycated Hemoglobin (HbA1c) (%)
Assessment of average blood glucose control over time.
Measured: 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.
Measured: Baseline, Week 6, Week 12, and Week 24.
Secondary outcomes (7)
Change from Baseline in Tumor Necrosis Factor-alpha (TNF-α) (pg/mL)
To evaluate the anti-inflammatory effects of Bletilla formosana.
Measured: Baseline, Week 6, Week 12, and Week 24.
Change from Baseline in Interleukin-6 (IL-6) (pg/mL)
To evaluate the anti-inflammatory effects of Bletilla formosana.
Measured: Baseline, Week 6, Week 12, and Week 24.
Change from Baseline in C-reactive protein (CRP) (mg/dL)
To evaluate the anti-inflammatory effects of Bletilla formosana.
Measured: Baseline, Week 6, Week 12, and Week 24.
Change from Baseline in Total Cholesterol (mg/dL)
Assessment of lipid profiles using standard laboratory methods
Measured: Baseline, Week 6, Week 12, and Week 24.
Change from Baseline in High-Density Lipoprotein (HDL) (mg/dL)
Assessment of lipid profiles using standard laboratory methods.
Measured: Baseline, Week 6, Week 12, and Week 24.
Change from Baseline in Low-Density Lipoprotein (LDL) (mg/dL)
Assessment of lipid profiles using standard laboratory methods.
Measured: Baseline, Week 6, Week 12, and Week 24.
Change from Baseline in Triglycerides (TG) (mg/dL)
Assessment of lipid profiles using standard laboratory methods.
Measured: Baseline, Week 6, Week 12, and Week 24.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2026
- Study start1 Jul 2026 (estimated)
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrediabetesStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 94 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Science and Technology Council
- Responsible party
- Principal investigator, YUAN-CHIEH YEH, Chang Gung Memorial Hospital
- Investigators
- Yuan-Chieh Yeh, MD, Principal investigator, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07704944
- Sponsor's protocol ID
- 202500720A3C6002
- Other IDs
- NSTC 114-2321-B-255-001
- Status last verified
- Jul 2026
- First submitted
- 23 Jun 2026
- Last updated
- 15 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Randomized, Double-Blind, Placebo-Controlled Pilot Trial Evaluating the Safety and Dose-Response of Bletilla Formosana in Prediabetic Subjects
- ClinicalTrials.gov ID
- NCT07704944
- Acronym / sponsor ID
- 202500720A3C6002
- Conditions
- Prediabetes
- Keywords
- Prediabetes, Bletilla formosana, Traditional Chinese Medicine, Herbal Medicine, Glycemic Control, Anti-inflammatory, Dose-Response Relationship, Phase I/II Trial
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 94 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Collaborators
- National Science and Technology Council
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 15 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| High-dose Bletilla formosana (BF) | Experimental | Drug: Bletilla formosana (BF) powderParticipants 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). |
| Low-dose Bletilla formosana (BF) | Experimental | Drug: Bletilla formosana (BF) powder, Other: PlaceboParticipants 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 | Placebo comparator | Other: PlaceboParticipants 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). |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bletilla formosana (BF) powderA 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. | Drug | High-dose Bletilla formosana (BF), Low-dose Bletilla formosana (BF) |
| PlaceboAn inactive powder matching the appearance and dosage form of the BF powder, consisting of starch and caramel coloring. | Other | Low-dose Bletilla formosana (BF), Placebo |
Primary outcome
Number of Participants with at Least One Treatment-Emergent Adverse Event (AE)
Time frame: From baseline to Week 24.
Incidence of all adverse events (AEs) graded by CTCAE v5.0.
Number of Participants with Serious Adverse Events (SAEs)
Time frame: From baseline to Week 24
Number of participants experiencing life-threatening or fatal events according to ICH-GCP definitions.
Change from Baseline in Fasting Plasma Glucose (FPG) (mg/dL)
Time frame: Baseline, Week 6, Week 12, and Week 24.
Change in fasting blood sugar levels to assess the preliminary glycemic efficacy of Bletilla formosana.
Change from Baseline in Glycated Hemoglobin (HbA1c) (%)
Time frame: Baseline, Week 6, Week 12, and Week 24.
Assessment of average blood glucose control over time.
Change from Baseline in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)
Time frame: Baseline, Week 6, Week 12, and Week 24.
Calculated using fasting insulin and glucose levels to assess changes in insulin sensitivity.
7 secondary outcomes
Change from Baseline in Tumor Necrosis Factor-alpha (TNF-α) (pg/mL)
Time frame: Baseline, Week 6, Week 12, and Week 24.
Change from Baseline in Interleukin-6 (IL-6) (pg/mL)
Time frame: Baseline, Week 6, Week 12, and Week 24.
Change from Baseline in C-reactive protein (CRP) (mg/dL)
Time frame: Baseline, Week 6, Week 12, and Week 24.
Change from Baseline in Total Cholesterol (mg/dL)
Time frame: Baseline, Week 6, Week 12, and Week 24.
Change from Baseline in High-Density Lipoprotein (HDL) (mg/dL)
Time frame: Baseline, Week 6, Week 12, and Week 24.
Change from Baseline in Low-Density Lipoprotein (LDL) (mg/dL)
Time frame: Baseline, Week 6, Week 12, and Week 24.
Change from Baseline in Triglycerides (TG) (mg/dL)
Time frame: Baseline, Week 6, Week 12, and Week 24.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2026.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yuan-Chieh Yeh, MD principal investigator
Chang Gung Memorial Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Bletilla formosana (BF) powder in people with Prediabetes, run by Chang Gung Memorial Hospital at 3 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yuan-Chieh Yeh, MD (+886-2-24313131 ext. 6320, b9005030@cgmh.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with at Least One Treatment-Emergent Adverse Event (AE) (time frame: From baseline to Week 24.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2026.