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

A 12-week, randomized, double-blinded, placebo-controlled clinical trial to evaluate the efficacy and safety of AGEs in lowering the level fo serum uric acid

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0004344

Enrollment

Registered

2019-10-17

Start date

2017-11-22

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 : [Test food] • Main ingredient name: Aster glehni extracts(AGE) • Properties and formulations: white coating Tablets • Content: 650 mg/tablet • Dosage & capacity: 2 times a day

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
serum uric acid concentration	—

Secondary

Measure	Time frame
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	—

Countries

Korea, Republic of

Contacts

Public ContactChang-O Kim

H Plus Yangji Hospital

for-the-nation@hanmail.net+82-1877-8875

Outcome results