Efficacy and Safety of Kui-Yuan Chewable Tablets in Patients With Hyperuricemia
NCT ID: NCT05913310
Last Updated: 2023-06-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
126 participants
INTERVENTIONAL
2023-07-31
2024-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Kui-Yuan Chewable Tablets
Kui-Yuan Chewable Tablets
Kui-Yuan chewable tablets are the optimal ingredients found in sunflower dish that can reduce uric acid and anti-gout, including flavonoids, Coumarin (including scopolamine) and phenolic acids.
Placebo of Kui-Yuan Chewable Tablets
Placedo of Kui-Yuan Chewable Tablets
Placedo of Kui-Yuan Chewable Tablets are composed of L-arabinose, food starch and a few auxiliary materials.
Interventions
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Kui-Yuan Chewable Tablets
Kui-Yuan chewable tablets are the optimal ingredients found in sunflower dish that can reduce uric acid and anti-gout, including flavonoids, Coumarin (including scopolamine) and phenolic acids.
Placedo of Kui-Yuan Chewable Tablets
Placedo of Kui-Yuan Chewable Tablets are composed of L-arabinose, food starch and a few auxiliary materials.
Eligibility Criteria
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Inclusion Criteria
* The participants did not experience any acute gout attacks before treatment
* The ECG of the participants was normal before treatment
Exclusion Criteria
* Those who have used allopurinol, probenecid, benzbromarone, febuxostat or traditional Chinese medicine with uric acid lowering effect within 4 weeks before enrollment
* Those who had a history of cardiovascular and cerebrovascular diseases such as stroke, TIA, MI, HF (NYHA grade II-IV), and coronary artery surgery (such as angioplasty, stent implantation, bypass grafting, etc.)
* Those who had a history of gastrointestinal ulcers or gastrointestinal bleeding
* Active liver disease or abnormal liver function, ALT and AST are more than 3 times the upper limit of normal
* Glomerular filtration rate (eGFR)\<30mL/min/1.73m2
* Those who are allergic or intolerant to any component in Kui-Yuan chewable tablets and placebo
* Those who had other autoimmune diseases
* Those who are taking or need to take aspirin, other salicylic acids, heparin, Dicoumarol and other anticoagulants and antiplatelet aggregation drugs
* Those who taking Diuretic
* Those who had a history of alcohol or drug dependence, or those who require long-term daily use of painkillers for any reason
* Pregnancy, lactation, or planned pregnancy within 3 months after the last study medication
18 Years
75 Years
ALL
No
Sponsors
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Quan Jiang
OTHER
Responsible Party
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Quan Jiang
chief physician
Central Contacts
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Other Identifiers
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2023023P7A01
Identifier Type: -
Identifier Source: org_study_id
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