A Study on the Improvement Effect of extract of Aster sphathulifolius Maxim on Human Applicatio
- Conditions
- Endocrine, nutritional and metabolic disease
- Registration Number
- KCT0005917
- Lead Sponsor
- Kyung Hee University Hospital at Gangdong
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 68
(1) obese (BMI: 25-30 kg/m2), non-diabetic (fasting glucose < 126 mg/dL and HbA1c < 6.5%), and aged 21~65,
(2) who do not have a treatment history of anti-obesity and/or anti-diabetic medication within 3 months
(3) who informed and voluntarily consented to participate to the study.
1)fasting glucose > 126 mg/ml or HbA1c > 6.5%;
2)subjects who had taken anti-diabetic medication and/or glucocorticoids within 3 months;
3)had serious illness history, including depression, heart disease, and cancer; drug or alcohol abusers;
4)had hepatic disease with AST or ALT > 3-fold than normal range; had kidney abnormality with creatinine level > 1.5mg/dL; individuals who need treatment for hyperthyroidism or hypothyroidism.
5) Those who have been taking glucocorticoids that may affect blood sugar within the last 3 months
6) Drug abusers or people with history (including alcohol)
7) Patients with a history of severe disease that may recur during or immediately after the clinical trial
8) individuals who need treatment for hyperthyroidism or hypothyroidism
(However, hypothyroidism that does not require treatment with TSH less than 10 µg/dl is not applicable)
9) Others who are judged to be unable to participate in clinical research
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Changes in Fasting glucose, Insulin, c-peptide after 12 weeks compared to baseline;Changes in HOMA-IR, HOMA-beta after 12 weeks compared to baseline
- Secondary Outcome Measures
Name Time Method Changes in glycoalbumin, Weight, body fat, waist circumference, Total cholesterol, Triglyceride, LDL-C, HDL-C after 12 weeks compared to baseline;Changes in HbA1C after 12 weeks compared to baseline