8 weeks, single-center, randomized, double-blind, placebo-controlled human study to assess the efficacy and safety of Aloe Extract Complex on inhibition of platelet aggregation and blood circulation.
- Conditions
- Not Applicable
- Registration Number
- KCT0000902
- Lead Sponsor
- Kim Jeong Moon Aloe
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 90
1) male smoker aged not less then 20 years averagely consuming 10 cigarettes per day.
2) not less then 70% of Platelet aggregation.
3) People who sign the informed consent form before participating in the study
1) subject with clinically significant myocardial infarction, angina pectoris,hemorrhagic lesion, cardiovascular disease under current medication or treatment
2) subject who has taken aspirin, anticoagulant, antiplatelet agent within 2 weeks
3)subject who has taken health functional food such as red ginseng, ginseng, chongkukjang, natto within 2 weeks
4)subject under treatment for uncontrolled hypertension
(over 160/100 mmHg)
5)subject under treatment for uncontrolled diabetes (fasting plasma glucose 180mg/dl or diabetes patient starting drugs within 3 months)
6)subject under treatment for thyroid disease etc. (However, subjects can be involved in the study based on doctor’s assessment)
7)subject with operation medical history within 3 months
8)subject whose creatinine level is twice higher than the normal range
9)subject whose AST(GOT) or ALT(GPT) level is three times higher than normal range
10)people complaining of a heartburn,dyspepsia, severe gut symptoms
11)subject scheduled for participating in another study during this study period or who had participated in other study within 3 months
12)subject who investigators think is not suitable for this study.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Platelet aggregation ;Serotonin;C-reactive protein ;blood coagulation test ;lipid test
- Secondary Outcome Measures
Name Time Method adverse events, clinical pathological tests, vital sign, weight, electrocardiography