Hyperuricemia
Conditions
Keywords
Hyperuricemia, Kui-Yuan Chewable, Randomized controlled trial
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.
Interventions
DRUGKui-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.
DRUGPlacedo of Kui-Yuan Chewable Tablets
Placedo of Kui-Yuan Chewable Tablets are composed of L-arabinose, food starch and a few auxiliary materials.
Sponsors
Quan Jiang
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Blood uric acid level\>7.0mg/dL (420 μmol/L) * The participants did not experience any acute gout attacks before treatment * 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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Proportion of sUA levels below 360 μmol/L | 3 months | Proportion of participants maintaining sUA levels below 360 μmol/L at the third month |
| 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) |
| Changes in BMI | 3 months | Changes in participants' BMI from baseline to the third month (combined with obesity) |
Contacts
Primary ContactQuan Jiang, M.D
Outcome results
None listed