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

Hyperuricemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05913310
• Other study ID #: 2023023P7A01
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: July 2023
• Est. completion date: August 2024

Study information

• Verified date: June 2023
• Source: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
• Contact: Quan Jiang, M.D
• Phone: +8613901081632
• Email: doctorjq[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 126
• Est. completion date: August 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Hyperuricemia

Intervention

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.
• Placedo of Kui-Yuan Chewable Tablets
Placedo of Kui-Yuan Chewable Tablets are composed of L-arabinose, food starch and a few auxiliary materials.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Quan Jiang

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Proportion of sUA levels below 360 µmol/L	Proportion of participants maintaining sUA levels below 360 µmol/L at the third month	3 months
Secondary	The number of gout attacks	The number of gout attacks from baseline to month 3	3 months
Secondary	Proportion of gout attacks	Proportion of participants reporting gout attacks from baseline to month 3	3 months
Secondary	Percentage change in sUA levels	Percentage change of participants in sUA levels from baseline to each visit	3 months
Secondary	Changes in BMI	Changes in participants' BMI from baseline to the third month (combined with obesity)	3 months
Secondary	Changes in blood pressure levels	Changes in participants' blood pressure levels from baseline to the third month (combined with hypertension)	3 months
Secondary	Changes in blood lipid levels	Changes in participants' blood lipid levels from baseline to the third month (combined with hyperlipidemia)	3 months
Secondary	Changes in fasting blood glucose levels	Changes in participants' fasting blood glucose levels from baseline to the third month (combined with diabetes)	3 months