Healthy VolunteersPhase 1NCT07532135
Safety of Mulberry Leaf Extract Capsule on Blood Glucose Control in Healthy Volunteer
A Phase 1 study testing Mulberry Leaf Extract in people with Healthy Volunteers and Non Diabetic Hyperglycemia, run by Chulalongkorn University at 1 site in Thailand.
Trial summary
Volunteers were divided into 2 groups: mulberry leaf extract capsule (DNJ 12mg) group and placebo group. They took the sample 3 times/day for 8 weeks. Complete blood count, Blood urea nitrogen (BUN), Creatinine, Aspartate transaminase (AST), Alanine aminotransferase (ALT), Alkaline phosphatase (ALP), Fasting plasma… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers, Non Diabetic Hyperglycemia
- What is being tested?
- Mulberry Leaf Extract
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteThailand
- Study dates
- 1 Oct 2025to 24 Sep 2026
- Phase
- Phase 1
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female age more than 18 years
- No Diabetis mellitus disease and no taking diabetes medication
- Blood sugar level less than 126 mg/dl and HbA1C less than 6.5
- Can using Thai language
- Willing to participate in the study
Who cannot join
- Allergic to mulberry extract
- Take mulberry extract in 2 weeks before participate in this study
- Take medications that have effect on blood sugar level such as steroid in 2 weeks before participate in this study
- Have uncontrolled disease
- Have AST, ALT, ALP more than 3 times of normal value, or estimated Glomerular Filtration Rate less than 30 ml/min/1.73 m2)
- Pregnancy or lactation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Thailand1 site, 1 recruiting
- Recruiting
Chulalongkorn
Bangkok
Pornanong Aramwit, Ph.D., +66899217255, aramwit@gmail.com
About this study
Volunteers were divided into 2 groups: mulberry leaf extract capsule (DNJ 12mg) group and placebo group. They took the sample 3 times/day for 8 weeks. Complete blood count, Blood urea nitrogen (BUN), Creatinine, Aspartate transaminase (AST), Alanine aminotransferase (ALT), Alkaline phosphatase (ALP), Fasting plasma glucose, HbA1c, and adverse effects were evaluated before and after 4 and 8 weeks.
Read the detailed description
Volunteers were divided into 2 groups: mulberry leaf extract capsule (DNJ 12mg) group and placebo group. They took the sample 3 times/day for 8 weeks. Complete blood count, Blood urea nitrogen (BUN), Creatinine, Aspartate transaminase (AST), Alanine aminotransferase (ALT), Alkaline phosphatase (ALP), Fasting plasma glucose, HbA1c, and adverse effects were evaluated before and after 4 and 8 weeks. Satisfaction was assessed after 8 weeks.
- Conditions
- Healthy Volunteers, Non Diabetic Hyperglycemia
- Being tested
- Mulberry Leaf Extract, Placebo
- Keywords
- Safety, mulberry, glucose, healthy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mulberry Leaf ExtractCombination product
They took the Mulberry leaf extract capsule (DNJ 12mg) 3 times/day for 8 weeks.
PlaceboOther
They took the sample 3 times/day for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Placebo group | Placebo comparator | They took the sample 3 times/day for 8 weeks. Receives: Other: Placebo |
| Mulberry leaf extract capsule (DNJ 12mg) group | Experimental | They took the sample 3 times/day for 8 weeks. Receives: Combination Product: Mulberry Leaf Extract |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aspartate transaminase (AST) level
Aspartate transaminase (AST) is in normal range.
Measured: 8 weeks
Alanine aminotransferase (ALT) level
Alanine aminotransferase (ALT) is in normal range.
Measured: 8 weeks
Blood urea nitrogel level
Blood urea nitrogen (BUN) is in normal range.
Measured: 8 weeks
Creatinine level
Creatinine is in normal range.
Measured: 8 weeks
Complete blood counts
Complete blood counts are in normal range.
Measured: 8 weeks
Adverse events
Adverse events are observed.
Measured: 8 weeks
Alkaline phosphatase (ALP) level
Alkaline phosphatase (ALP) is in normal range.
Measured: 8 weeks
Secondary outcomes (1)
Blood glucose level
Fasting plasma glucose and HbA1c are in normal range.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2026
- Study start1 Oct 2025
- Primary completion1 Sep 2026 (estimated)
- Study completion24 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Chulalongkorn UniversityThe 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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Volunteers were divided into 2 groups: mulberry leaf extract capsule (DNJ 12mg) group and placebo group.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pornanong Aramwit, Pharm.D., Ph.D, Chulalongkorn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07532135
- Sponsor's protocol ID
- 0427/68
- Status last verified
- Apr 2026
- First submitted
- 9 Apr 2026
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety of Mulberry Leaf Extract Capsule on Blood Glucose Control in Healthy Volunteer
- ClinicalTrials.gov ID
- NCT07532135
- Acronym / sponsor ID
- 0427/68
- Conditions
- Healthy Volunteers, Non Diabetic Hyperglycemia
- Keywords
- Safety, mulberry, glucose, healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 24 Sep 2026 (estimated)
- First posted
- 15 Apr 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.
Volunteers were divided into 2 groups: mulberry leaf extract capsule (DNJ 12mg) group and placebo group. They took the sample 3 times/day for 8 weeks. Complete blood count, Blood urea nitrogen (BUN), Creatinine, Aspartate transaminase (AST), Alanine aminotransferase (ALT), Alkaline phosphatase (ALP), Fasting plasma glucose, HbA1c, and adverse effects were evaluated before and after 4 and 8 weeks.
Detailed description
Volunteers were divided into 2 groups: mulberry leaf extract capsule (DNJ 12mg) group and placebo group. They took the sample 3 times/day for 8 weeks. Complete blood count, Blood urea nitrogen (BUN), Creatinine, Aspartate transaminase (AST), Alanine aminotransferase (ALT), Alkaline phosphatase (ALP), Fasting plasma glucose, HbA1c, and adverse effects were evaluated before and after 4 and 8 weeks. Satisfaction was assessed after 8 weeks.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Volunteers were divided into 2 groups: mulberry leaf extract capsule (DNJ 12mg) group and placebo group.
| Arm | Type | Receives |
|---|---|---|
| Placebo group | Placebo comparator | Other: PlaceboThey took the sample 3 times/day for 8 weeks. |
| Mulberry leaf extract capsule (DNJ 12mg) group | Experimental | Combination Product: Mulberry Leaf ExtractThey took the sample 3 times/day for 8 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female age more than 18 years
- No Diabetis mellitus disease and no taking diabetes medication
- Blood sugar level less than 126 mg/dl and HbA1C less than 6.5
- Can using Thai language
- Willing to participate in the study
Key exclusion criteria (6 listed)
- Allergic to mulberry extract
- Take mulberry extract in 2 weeks before participate in this study
- Take medications that have effect on blood sugar level such as steroid in 2 weeks before participate in this study
- Have uncontrolled disease
- Have AST, ALT, ALP more than 3 times of normal value, or estimated Glomerular Filtration Rate less than 30 ml/min/1.73 m2)
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 |
|---|---|---|
| Mulberry Leaf ExtractThey took the Mulberry leaf extract capsule (DNJ 12mg) 3 times/day for 8 weeks. | Combination product | Mulberry leaf extract capsule (DNJ 12mg) group |
| PlaceboThey took the sample 3 times/day for 8 weeks. | Other | Placebo group |
Primary outcome
Aspartate transaminase (AST) level
Time frame: 8 weeks
Aspartate transaminase (AST) is in normal range.
Alanine aminotransferase (ALT) level
Time frame: 8 weeks
Alanine aminotransferase (ALT) is in normal range.
Blood urea nitrogel level
Time frame: 8 weeks
Blood urea nitrogen (BUN) is in normal range.
Creatinine level
Time frame: 8 weeks
Creatinine is in normal range.
Complete blood counts
Time frame: 8 weeks
Complete blood counts are in normal range.
Adverse events
Time frame: 8 weeks
Adverse events are observed.
Alkaline phosphatase (ALP) level
Time frame: 8 weeks
Alkaline phosphatase (ALP) is in normal range.
1 secondary outcome
Blood glucose level
Time frame: 8 weeks
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 23 Apr 2026.
- Individual participant dataSharing planned: No
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Screening Protocol
Pain
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Mulberry Leaf Extract in people with Healthy Volunteers and Non Diabetic Hyperglycemia, run by Chulalongkorn University at 1 site in Thailand.
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 6 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: looking for participants now, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. 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 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.
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 Pornanong Aramwit, Ph.D (+66899217255, aramwit@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aspartate transaminase (AST) level (time frame: 8 weeks). The study lists 7 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 23 Apr 2026.