A 12week, double-blind, randomized, placebo-controlled clinical trial for the evaluation of the efficacy and safety of Boehmeria nivea extract on improving blood glucose.
- Conditions
- Endocrine, nutritional and metabolic disease
- Registration Number
- KCT0000846
- Lead Sponsor
- Hansan Ramie Agricultural Cooperative
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 80
? Adults aged 20 years old or more and less than 65 years old
? Fasting glucose > 100 mg/dl and < 125 mg/dl or 75g oral GTT post-prandial 2 hour value of 140-199 mg/dl on screening
? Subjects who agree the participation in the trial and submit informed consent before the beginning of the trial
? Subjects who had surgery previously within 6 months before the trial
? Subjects who had insulin therapy, and/or oral hypoglucosuric agent previously within 3 months before the trial
? Subjects who took corticosteroid drug previously within 2 months before the trial
? TSH < 0.1 uU/ml or > 10 uU/ml
? More than 2 times upper limit of creatinine
? More than 3 times upper limit of AST and/or ALT
? Subjects who complains of indigestion, gastric soreness or severe GI symptoms
? Subjects who are admitted, taking medicine, or having rehabilitation treatment due to alcohol abuse, cardiac disease, or CNS diseases on history taking
? Malnutrition or poor nutritional status
? Pregnant or possibility of pregnancy, or breast feeding mothers
? Designated persons who will take part in the other trial during this trial
? Subjects who had taken part in the other trial previously within 3 months before the trial
? Inappropriate person decided by investigator
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Fasting blood glucose;2 hours postprandial blood glucose (OGTT);OGTT, AUC(0~2hr);HbA1c;Insulin;C-peptide;HOMA-IR, HOMA-beta, QUICKI, Matsuda index
- Secondary Outcome Measures
Name Time Method Adverse events;Clinical pathology (hematology / blood chemical tests, urine tests);Vital signs (pulse, blood pressure);Electrocardiogram;Weight