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Effect of Aster glehni extracts on lowering serum uric acid in mild hyperuricemic subjects: A randomized, placebo-controlled trial

Not Applicable
Completed
Conditions
Endocrine, nutritional and metabolic disease
Registration Number
KCT0004344
Lead Sponsor
Koreaeundan
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
All
Target Recruitment
80
Inclusion Criteria

1. Korean adults aged between 20 and 75 years
2. A person whose blood uric acid concentration is higher than 7.0 mg/dL but lower than 9.0 mg/dL
3. A person who agrees to participate in this trial and who signs the written consent form

Exclusion Criteria

1. Persons who were diagnosed with gout
2. Someone who has experienced gout attacks more than once
3. Those who are hospitalized, treated with drugs, or rehabilitated with severe cerebrovascular disease or severe heart disease
4. Persons with mental illnesses such as with schizophrenia, depression, drug addiction, etc.
5. Persons with alcohol abuse or high dependence on alcohol
6. Those who have been taking uric acid lowering agents (allopurinol, phebostostart, probenside, etc.)
7. Those who have a history of urinary stones
8. Those who have taken functional foods, antacids, vitamin K antagonists, oral contraceptives, antifungal agents, and large amounts of grapefruit juice that affect the absorption, metabolism, excretion, and uric acid levels of this testing food within 1 week of Visit 2 (Baseline)
9. Those who are taking thiazide diuretics within 4 weeks of Visit 1 (Screening)
10. Patients with uncontrolled hypertension (160/100 mmHg or more, based on measurement after 10 minutes of stabilization)
11. Uncontrolled diabetic patients (fasting blood glucose above 180 mg/dL)
12. Persons with TSH 0.1 µIU/ml or less, or greater than 10 µIU/ml
13. Person whose AST (GOT) or ALT (GPT) is 3 times or more of the normal range of the study site
14. Person whose creatinine is more than twice the normal range of the laboratory
15. Persons planning to conceive during pregnancy, breastfeeding or within three months
16. Participants in other clinical trials within 2 months of the start of this trial or plan to participate in other clinical trials during this trial period
17. Persons deemed to be inappropriate for this application

Study & Design

Study Type
Interventional Study
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
serum uric acid concentration
Secondary Outcome Measures
NameTimeMethod
Proportion of subjects with a uric acid concentration of 7.0 mg/dL or less in the blood;CRP concentraton in the blood;TNF-a concentration in the blood;Xanthine oxidase activity in the blood;Clinical laboratory test(blood, urine);Adverse events;Vital signs;Electrocardiogram
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