Safety and hypoglycemic Efficacy of Bitter melon (Momordica charantin L.) capsules in pre - diabetes patients
Phase 4
Completed
- Conditions
- Pre diabetes
- Registration Number
- TCTR20180222004
- Lead Sponsor
- ARDA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 220
Inclusion Criteria
1 Fasting plasma glucose 100-125mg /dl or glycated hemoglobin (HbA1c) 5.7-6.4%
2 Age 30-60 years old
Exclusion Criteria
1 Serum creatinine higher than 1.8 mg/dL
2 Serum alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin or alkaline phosphatase higher than 2.5 times of the upper normal
range
3 Hemogloblin lower than 10 g/dL
4 Heart disease (Angina, heart failure with left ventricular hypertrophy (LVH))
5 Pregnant and lactating women
6 Patients was present sulfonylureas, metformin, thiazolidinediones, glitinides, alphaglucosidase
inhibitors or insulin use prior to study enrollment participation in another clinical trial within 30 days of screening
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Fasting plasma glucose 6 month Fasting plasma glucose level
- Secondary Outcome Measures
Name Time Method iver function test 6 month Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) level