A 8-week, multi-center, randomized, double-blind, placebo-controlled human trial to evaluate the efficacy and safety of Hwangchil-unripe Bokbunja Extract Mixtures on blood pressure

Wonkwang University Oriental Medical Hospital, Jeonju0 个研究点目标入组 88 人开始时间: 待定最近更新: 2019年11月5日

试验速览

暂无简介。

•1)Males and females aged 19-75 years at the screening examination
•2)Participants who have no history to treat for hypertension within the last 3 months and with 120=systolic blood pressure(SBP)=139 or 80=diastolic blood pressure(DBP)=89
•3)Participants who have fully understand the information provided about the study voluntarily decided to participate and agree to comply with precautions

•1)Patients with 160=systolic blood pressure(SBP) or 100=diastolic blood pressure(DBP)
•2)Patients with severe diseases for clinically significant
•(i.e., Heart failure, myocardial infarction, cerebrovascular disease, arteriosclerosis, diabetes mellitus, thyroid disease, gastric ulcer, gastric bleeding, infectious disease, systemic inflammatory disease, acute inflammation, malignant tumor, kidney disease, renal dysfunction, liver disease, hypertensive retinopathy, Crohn’s disease, etc.)
•3)Patients who took drugs for hypertension within the last 3 months
•4)Patients with a history of antipsychotic medication use within 2 months prior to the screening examination
•5)Patients with a history of medicine or alcohol abuse
•6)Patients who have participated in other clinical trials within 2 months prior to the screening examination
•7)Patients who the following results in a laboratory test
•? Aspartate Transaminase(AST), Alanine Transaminase(ALT) > Reference range 3 times upper limit
•? Serum Creatinine > 2.0 mg/dL
•8)Patients who are pregnant or breastfeeding
•9)Patients who may become pregnant and have not used appropriate contraceptives (excluding those who have undergone sterilization surgery)
•10)Patients who are judged ineligible to participate in the trial by the principal investigator for other reasons, including laboratory test outcomes

发起方

Wonkwang University Oriental Medical Hospital, Jeonju