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

Quan Jiang

Status and phase: Not yet enrolling; Phase 4

Conditions: Hyperuricemia

Treatments: Drug: Placedo of Kui-Yuan Chewable Tablets; Drug: Kui-Yuan Chewable Tablets

Study type: Interventional

Funder types: Other

Identifiers

NCT05913310

2023023P7A01

Details and patient eligibility

About

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.

Enrollment: 126 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

126 participants in 2 patient groups, including a placebo group

Kui-Yuan Chewable Tablets

Active Comparator group

Treatment:

Drug: Kui-Yuan Chewable Tablets

Placebo of Kui-Yuan Chewable Tablets

Placebo Comparator group

Treatment:

Drug: Placedo of Kui-Yuan Chewable Tablets