Safety of Mulberry Leaf Extract Capsule on Blood Glucose Control in Healthy Volunteer

April 20, 2026 updated by: Pornanong Aramwit, Pharm.D., Ph.D, Chulalongkorn University
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

48

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Thailand
      • Bangkok, Thailand
        • Recruiting
        • Chulalongkorn
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo group
They took the sample 3 times/day for 8 weeks.
Other: Placebo
They took the sample 3 times/day for 8 weeks.
Experimental: Mulberry leaf extract capsule (DNJ 12mg) group
They took the sample 3 times/day for 8 weeks.
Combination product: Mulberry Leaf Extract
They took the Mulberry leaf extract capsule (DNJ 12mg) 3 times/day for 8 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete blood counts
Time Frame: 8 weeks
Complete blood counts are in normal range.
8 weeks
Adverse events
Time Frame: 8 weeks
Adverse events are observed.
8 weeks
Aspartate transaminase (AST) level
Time Frame: 8 weeks
Aspartate transaminase (AST) is in normal range.
8 weeks
Alanine aminotransferase (ALT) level
Time Frame: 8 weeks
Alanine aminotransferase (ALT) is in normal range.
8 weeks
Blood urea nitrogel level
Time Frame: 8 weeks
Blood urea nitrogen (BUN) is in normal range.
8 weeks
Creatinine level
Time Frame: 8 weeks
Creatinine is in normal range.
8 weeks
Alkaline phosphatase (ALP) level
Time Frame: 8 weeks
Alkaline phosphatase (ALP) is in normal range.
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood glucose level
Time Frame: 8 weeks
Fasting plasma glucose and HbA1c are in normal range.
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chulalongkorn University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2025

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 24, 2026

Study Registration Dates

First Submitted

April 9, 2026

First Submitted That Met QC Criteria

April 9, 2026

First Posted (Actual)

April 15, 2026

Study Record Updates

Last Update Posted (Actual)

April 23, 2026

Last Update Submitted That Met QC Criteria

April 20, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0427/68

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Healthy Volunteers

Clinical Trials on Placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kyrgyzstan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe