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NCT Number: NCT07532135

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

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.

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Key information

Conditions

Healthy Volunteers Non Diabetic Hyperglycemia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

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. Satisfaction was assessed after 8 weeks.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mulberry Leaf Extract

Combination Product

They took the Mulberry leaf extract capsule (DNJ 12mg) 3 times/day for 8 weeks.

Placebo

Other

They took the sample 3 times/day for 8 weeks.

Primary outcomes

  1. Aspartate transaminase (AST) level

    Time frame: 8 weeks

    Aspartate transaminase (AST) is in normal range.

  2. Alanine aminotransferase (ALT) level

    Time frame: 8 weeks

    Alanine aminotransferase (ALT) is in normal range.

  3. Blood urea nitrogel level

    Time frame: 8 weeks

    Blood urea nitrogen (BUN) is in normal range.

  4. Creatinine level

    Time frame: 8 weeks

    Creatinine is in normal range.

  5. Complete blood counts

    Time frame: 8 weeks

    Complete blood counts are in normal range.

  6. Adverse events

    Time frame: 8 weeks

    Adverse events are observed.

  7. Alkaline phosphatase (ALP) level

    Time frame: 8 weeks

    Alkaline phosphatase (ALP) is in normal range.

Secondary outcomes

  1. Blood glucose level

    Time frame: 8 weeks

    Fasting plasma glucose and HbA1c are in normal range.

Study contacts

Contact information is provided by the study sponsor or research team.

Pornanong Aramwit, Ph.D

CONTACT

[email protected]

+66899217255

Sponsors and collaborators

Lead sponsor

Chulalongkorn University

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 15, 2026
Registry last updated
Apr 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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