Efficacy and safety of Hwangchil-unripe Bokbunja Extract Mixtures on blood pressure

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0004300

Enrollment

Registered

2019-10-07

Start date

2017-12-26

Completion date

Unknown

Last updated

2019-11-05

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 : Hwangchil-unripe Bokbunja Extract Mixtures group: once a day for 2 capsules, before dinner, for 8 weeks(900mg/day for Hwangchil-unripe Bokbunja Extract Mixtures) Placebo group: on

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
SBP; Systolic Blood Pressure;DBP; Diastolic Blood Pressure	—

Secondary

Measure	Time frame
MAP; Mean arterial pressure;PP; Pulse Pressure;ACE(Angiotensin Converting Enzyme) activity;Renin activity;Aldosterone;hs-CRP; High sensitivity C-reactive protein	—

Countries

Korea, Republic of

Contacts

Public ContactJongcheon Joo

Wonkwang University Oriental Medical Hospital, Jeonju

jcjoo2000@hanmail.net+82-63-270-1073

Outcome results