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

NCT05913310 | Unknown Phase 4

• 1 other identifier: 2023023P7A01
• Study Type: interventional
• Target: 126
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hyperuricemia

Keywords

Hyperuricemia; Kui-Yuan Chewable; Randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Proportion of sUA levels below 360 μmol/L

  3 months

• The number of gout attacks

  3 months

• Proportion of gout attacks

  3 months

• Percentage change in sUA levels

  3 months

• Changes in BMI

  3 months

Study Arms (2)

Kui-Yuan Chewable Tablets

ACTIVE COMPARATOR

Drug: Kui-Yuan Chewable Tablets

Placebo of Kui-Yuan Chewable Tablets

PLACEBO COMPARATOR

Drug: Placedo of Kui-Yuan Chewable Tablets

Interventions

Kui-Yuan Chewable Tablets DRUG

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.

Kui-Yuan Chewable Tablets

Placedo of Kui-Yuan Chewable Tablets DRUG

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

Placebo of Kui-Yuan Chewable Tablets

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Quan Jiang: lead

MeSH Terms

Conditions

Hyperuricemia

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Quan Jiang, M.D

CONTACT

+8613901081632; doctorjq@126.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: chief physician

Study Record Dates

• First Submitted: June 9, 2023
• First Posted: June 22, 2023
• Study Start: July 1, 2023
• Primary Completion: July 1, 2024
• Study Completion: August 1, 2024
• Last Updated: June 22, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share