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8 weeks, single-center, randomized, double-blind, placebo-controlled clinical trial for the evaluation of the efficacy and safety of Rubus coreanus extract on inhibition of platelet aggregation and blood coagulation

8 weeks, single-center, randomized, double-blind, placebo-controlled clinical trial for the evaluation of the efficacy and safety of Rubus coreanus extract on inhibition of platelet aggregation and blood coagulation

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
CRIS
Registry ID
KCT0000915
Enrollment
80
Registered
2013-11-12
Start date
2013-10-16
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

Others(Rubus coreanus extract (health functional food)) : treatment group: The main ingredient is Rubus coreanus extract, 2 times/day, 3 capsule/time after meal or before meal. Placebo group: The mai

Sponsors

Lee’s Biotech
Lead Sponsor

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 antioxidant(vitamin C, E), 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

MeasureTime frame
Platelet aggregation

Secondary

MeasureTime frame
lipid test;C-reactive protein ;blood coagulation test

Countries

Korea, Republic of

Contacts

Public ContactHONG HEE

Seoul National University Hospital

lottie0@hanmail.net+82-2-2072-3336

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026