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Recruiting Phase 1 NCT07532135

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

Phase 1 – testing safety in a small group of people
Conditions: Healthy Volunteers Non Diabetic Hyperglycemia

Sponsor: Chulalongkorn University

trial.available_in: БГ
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.
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.
Who can participate
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
Interventions
Mulberry Leaf Extract
COMBINATION_PRODUCT
Placebo
OTHER
Locations 1
Thailand (1)
Chulalongkorn
Bangkok
Pornanong Aramwit, Ph.D.
Technical details
Status
Recruiting
Phase
Phase 1
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
01.10.2025
Completion date
24.09.2026
Registry ID
NCT07532135
Source
clinicaltrials.gov
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