Safety of Mulberry Leaf Extract Capsule on Blood Glucose Control in Healthy Volunteer
Overview
- Phase
- Phase 1
- Status
- Recruiting
- Sponsor
- Chulalongkorn University
- Enrollment
- 48
- Locations
- 1
- Primary Endpoint
- Liver function
Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Placebo group
They took the sample 3 times/day for 8 weeks.
Intervention: Placebo (Other)
Mulberry leaf extract capsule (DNJ 12mg) group
They took the sample 3 times/day for 8 weeks.
Intervention: Mulberry Leaf Extract (Combination Product)
Outcomes
Primary Outcomes
Liver function
Time Frame: 8 weeks
Aspartate transaminase (AST), Alanine aminotransferase (ALT), and Alkaline phosphatase (ALP) are in normal range.
Renal function
Time Frame: 8 weeks
Blood urea nitrogen (BUN) and Creatinine are in normal range.
Complete blood counts
Time Frame: 8 weeks
Complete blood counts are in normal range.
Adverse events
Time Frame: 8 weeks
Adverse events are observed.
Secondary Outcomes
- Blood glucose level(8 weeks)
Investigators
Pornanong Aramwit, Pharm.D., Ph.D
Professor
Chulalongkorn University