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

Phase 4

Not yet recruiting

• Conditions: Hyperuricemia
• Interventions: Drug: Kui-Yuan Chewable Tablets; Drug: Placedo of Kui-Yuan Chewable Tablets

• Registration Number: NCT05913310
• Lead Sponsor: Quan Jiang

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-06
• Study First Submitted: 2023-06-09
• Study First Submitted QC: 2023-06-18
• Last Update Submitted: 2023-06-18
• Study First Posted: 2023-06-22
• Last Update Posted: 2023-06-22
• Study Start: 2023-07
• Primary Completion: 2024-07
• Study Completion: 2024-08

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 126

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Kui-Yuan Chewable Tablets	Kui-Yuan Chewable Tablets	-
Placebo of Kui-Yuan Chewable Tablets	Placedo of Kui-Yuan Chewable Tablets	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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)