Efficacy and Safety of Kui-Yuan Chewable Tablets in Patients With Hyperuricemia

Study Overview
=================
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.

Official Title
-----------------
A Randomized Controlled Study of Kui-Yuan Chewable Tablets in the Treatment of Hyperuricemia

Conditions
-----------------
Hyperuricemia

Intervention / Treatment
-----------------
* Drug: Kui-Yuan Chewable Tablets
* Drug: Placedo of Kui-Yuan Chewable Tablets


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Kui-Yuan Chewable Tablets<br> | Drug: Kui-Yuan Chewable Tablets<br>* 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.<br>|
| Placebo Comparator: Placebo of Kui-Yuan Chewable Tablets<br> | Drug: Placedo of Kui-Yuan Chewable Tablets<br>* Placedo of Kui-Yuan Chewable Tablets are composed of L-arabinose, food starch and a few auxiliary materials.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hyperuricemia, Kui-Yuan Chewable, Randomized controlled trial