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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Kui-Yuan Chewable Tablets | Active Comparator |
| |
| Placebo of Kui-Yuan Chewable Tablets | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Kui-Yuan Chewable Tablets | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of sUA levels below 420 μmol/L | Proportion of participants maintaining sUA levels below 420 μmol/L at the third month | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of sUA levels below 360 μmol/L | Proportion of participants maintaining sUA levels below 360 μmol/L at the third month | 3 months |
| The number of gout attacks | The number of gout attacks from baseline to month 3 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Quan Jiang, M.D | Contact | +8613901081632 | doctorjq@126.com |
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| ID | Term |
|---|---|
| D033461 | Hyperuricemia |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Placedo of Kui-Yuan Chewable Tablets | Drug | Placedo of Kui-Yuan Chewable Tablets are composed of L-arabinose, food starch and a few auxiliary materials. |
|
| 3 months |
| Proportion of gout attacks | Proportion of participants reporting gout attacks from baseline to month 3 | 3 months |
| Percentage change in sUA levels | Percentage change of participants in sUA levels from baseline to each visit | 3 months |
| Changes in BMI | Changes in participants' BMI from baseline to the third month (combined with obesity) | 3 months |
| Changes in blood pressure levels | Changes in participants' blood pressure levels from baseline to the third month (combined with hypertension) | 3 months |
| Changes in blood lipid levels | Changes in participants' blood lipid levels from baseline to the third month (combined with hyperlipidemia) | 3 months |
| Changes in fasting blood glucose levels | Changes in participants' fasting blood glucose levels from baseline to the third month (combined with diabetes) | 3 months |