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Recruiting NCT07532135

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

Phase I Interventional Healthy Volunteers Non Diabetic Hyperglycemia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Mulberry Leaf Extract, Placebo.
Who it may be relevant to
Registry conditions: Healthy Volunteers, Non Diabetic Hyperglycemia. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Thailand
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Combination product Mulberry Leaf Extract
    They took the Mulberry leaf extract capsule (DNJ 12mg) 3 times/day for 8 weeks.
  • Other Placebo
    They took the sample 3 times/day for 8 weeks.

Primary outcome measures

  • Aspartate transaminase (AST) level [Time frame: 8 weeks]
  • Alanine aminotransferase (ALT) level [Time frame: 8 weeks]
  • Blood urea nitrogel level [Time frame: 8 weeks]
  • Creatinine level [Time frame: 8 weeks]
  • Complete blood counts [Time frame: 8 weeks]
  • Adverse events [Time frame: 8 weeks]
  • Alkaline phosphatase (ALP) level [Time frame: 8 weeks]
Secondary outcome measures (1)
  • Blood glucose level [Time frame: 8 weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Other

Study locations

Thailand · 1 center
  • Chulalongkorn — Bangkok

Identifiers

NCT: NCT07532135 · 0427/68

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗