Efficacy and Safety of Kui-Yuan Chewable Tablets in Patients With Hyperuricemia
Study Details
Study Description
Brief Summary
This study is a multi-center, randomized, double-blinded, controlled trial with two parallel arms. The aim of the study is to evaluate efficacy and safety of Kui-Yuan chewable tablets in patients with hyperuricemia.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Kui-Yuan Chewable Tablets
|
Drug: 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 Comparator: Placebo of Kui-Yuan Chewable Tablets
|
Drug: Placedo of Kui-Yuan Chewable Tablets
Placedo of Kui-Yuan Chewable Tablets are composed of L-arabinose, food starch and a few auxiliary materials.
|
Outcome Measures
Primary Outcome Measures
- Proportion of sUA levels below 420 μmol/L [3 months]
Proportion of participants maintaining sUA levels below 420 μmol/L at the third month
Secondary Outcome Measures
- Proportion of sUA levels below 360 μmol/L [3 months]
Proportion of participants maintaining sUA levels below 360 μmol/L at the third month
- The number of gout attacks [3 months]
The number of gout attacks from baseline to month 3
- Proportion of gout attacks [3 months]
Proportion of participants reporting gout attacks from baseline to month 3
- Percentage change in sUA levels [3 months]
Percentage change of participants in sUA levels from baseline to each visit
- Changes in BMI [3 months]
Changes in participants' BMI from baseline to the third month (combined with obesity)
- Changes in blood pressure levels [3 months]
Changes in participants' blood pressure levels from baseline to the third month (combined with hypertension)
- Changes in blood lipid levels [3 months]
Changes in participants' blood lipid levels from baseline to the third month (combined with hyperlipidemia)
- Changes in fasting blood glucose levels [3 months]
Changes in participants' fasting blood glucose levels from baseline to the third month (combined with diabetes)
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Blood uric acid level>7.0mg/dL (420 μmol/L)
-
The participants did not experience any acute gout attacks before treatment
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The ECG of the participants was normal before treatment
Exclusion Criteria:
-
Secondary Hyperuricemia caused by kidney disease, blood disease, or taking certain drugs, tumor radiotherapy and chemotherapy, organ transplantation, etc
-
Those who have used allopurinol, probenecid, benzbromarone, febuxostat or traditional Chinese medicine with uric acid lowering effect within 4 weeks before enrollment
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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.)
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Those who had a history of gastrointestinal ulcers or gastrointestinal bleeding
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Active liver disease or abnormal liver function, ALT and AST are more than 3 times the upper limit of normal
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Glomerular filtration rate (eGFR)<30mL/min/1.73m2
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Those who are allergic or intolerant to any component in Kui-Yuan chewable tablets and placebo
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Those who had other autoimmune diseases
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Those who are taking or need to take aspirin, other salicylic acids, heparin, Dicoumarol and other anticoagulants and antiplatelet aggregation drugs
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Those who taking Diuretic
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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
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Quan Jiang
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2023023P7A01