None listed
Conditions
Interventions
Dietary Supplement : Test food (DKB114)
Main ingredient name: DKB114
Properties and formulations: Pale yellow coatings Tablets
Content: 1000mg / 1 tablet
DOSAGE AND ADMINISTRATION: 2 times a day, 2 t
Sponsors
Dunsan Korean Medicine Hospital of Daejeon University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Male and female between 20 and 75 years of age 2) Those whose blood uric acid concentration is more than 7.0mg / dl to less than 9.0mg / dl 3) Those who have agreed to participate in this human body test before signing the human body test and have signed the informed consent
Exclusion criteria
Exclusion criteria: 1) Those who have been diagnosed with gout (based on ACR / EULAR: 2015). 2) Those who are hospitalized, medicated or rehabilitated with severe cerebrovascular disease (cerebral infarction, cerebral hemorrhage, etc.), severe heart disease (unstable angina, myocardial infarction, arrhythmia requiring heart failure treatment) 3) Those who are being treated for mental illnesses such as depression, depression, drug dependence 4) Alcohol abuse and dependence 5) Those who have taken uric acid inhibitors (allopurinol, phenytoestat, provenesid, etc.) 6) Those taking thiazide diuretics within 4 weeks of the start of the study 7) Those with history of urinary tract absences 8) Patients with uncontrolled hypertension (over 160 / 100mmHg, after 10 minutes of stabilization) 9) Unregulated diabetic patients (HbA1c> 8%) 10) TSH Less than 0.1 uIU / ml, or 10 uIU / ml or more, or free T4 is outside the normal range 11) AST (GOT) or ALT (GPT) is more than twice the normal range of the laboratory. 12) Creatinine of 2mg / dl or more 13) Those planning to become pregnant during pregnancy, during lactation, or within 3 months. 14) Those who have participated in other clinical studies within 2 months of the start of the human body test or plan to participate in other clinical studies 15) The person who is deemed inappropriate by this test
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary efficacy end point (before and after ingestion of serum uric acid);Secondary efficacy parameters (Xanthine oxidase activity, blood glucose, CRP, homocysteine, TNF-a, IL-6, NO, Apoprotein B) | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety Variables - Adverse Events;Safety Variables - pathological laboratory examination;Safety Variables - Vital sign, weight;Safety Variables - ECG;Safety Variables - Drinking habits questionnaire;Safety Variables - BMI, Waist circumference size | — |
Countries
Korea, Republic of
Contacts
Public ContactHWIHYEON SHIN
Dunsan Korean Medicine Hospital of Daejeon University
Outcome results
None listed