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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Hyperuricemia
• Intervention / Treatment: Drug: Kui-Yuan Chewable Tablets; Drug: Placedo of Kui-Yuan Chewable Tablets

• Study Type: Interventional
• Enrollment (Estimated): 126
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Quan Jiang, M.D; Phone Number: +8613901081632; Email: doctorjq@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

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

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

Collaborators and Investigators

• Sponsor: Quan Jiang

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2023
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): August 1, 2024

Study Registration Dates

• First Submitted: June 9, 2023
• First Submitted That Met QC Criteria: June 18, 2023
• First Posted (Actual): June 22, 2023

Study Record Updates

• Last Update Posted (Actual): June 22, 2023
• Last Update Submitted That Met QC Criteria: June 18, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Randomized controlled trial; Hyperuricemia; Kui-Yuan Chewable
• Additional Relevant MeSH Terms: Pathologic Processes; Hyperuricemia
• Other Study ID Numbers: 2023023P7A01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No