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

ConditionsHealthy VolunteersNon Diabetic Hyperglycemia
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorChulalongkorn University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Mulberry Leaf Extract

    Combination product

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

  • Placebo

    Other intervention

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

Treatment groups

48 Participants
are divided into 2 treatment groups
Group A: Placebo groupPlacebo comparator 1 intervention
Group B: Mulberry leaf extract capsule (DNJ 12mg) groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Aspartate transaminase (AST) level

Aspartate transaminase (AST) is in normal range.

Time frame
8 weeks
2

Alanine aminotransferase (ALT) level

Alanine aminotransferase (ALT) is in normal range.

Time frame
8 weeks
3

Blood urea nitrogel level

Blood urea nitrogen (BUN) is in normal range.

Time frame
8 weeks
4

Creatinine level

Creatinine is in normal range.

Time frame
8 weeks

Secondary outcomes

1

Blood glucose level

Fasting plasma glucose and HbA1c are in normal range.

Time frame
8 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Chulalongkorn University

Lead sponsor

Source ClinicalTrials.gov
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