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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05913310
Other study ID # 2023023P7A01
Secondary ID
Status Not yet recruiting
Phase Phase 4
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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