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.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0000902

Enrollment

Registered

2013-11-01

Start date

2013-10-22

Completion date

Unknown

Last updated

2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Dietary Supplement : Experimental group: The main ingredient is Aloe Extract Complex, 380mg/1 capsule, 3times/day, 3capsule after breakfast and lunch, 4capsule after dinner. Placebo group: The main i

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
Platelet aggregation ;Serotonin;C-reactive protein ;blood coagulation test ;lipid test	—

Secondary

Measure	Time frame
adverse events, clinical pathological tests, vital sign, weight, electrocardiography	—

Countries

Korea, Republic of

Contacts

Public ContactKim Mi-Sun

Yonsei University Health System, Severance Hospital

Outcome results