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

Primary Purpose

Hyperuricemia

Status
Not yet recruiting
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Kui-Yuan Chewable Tablets
Placedo of Kui-Yuan Chewable Tablets
Sponsored by
Quan Jiang
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyperuricemia focused on measuring Hyperuricemia, Kui-Yuan Chewable, Randomized controlled trial

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    Kui-Yuan Chewable Tablets

    Placebo of Kui-Yuan Chewable Tablets

    Arm Description

    Outcomes

    Primary Outcome Measures

    Proportion of sUA levels below 420 μmol/L
    Proportion of participants maintaining sUA levels below 420 μmol/L at the third month

    Secondary Outcome Measures

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

    Full Information

    First Posted
    June 9, 2023
    Last Updated
    June 18, 2023
    Sponsor
    Quan Jiang
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05913310
    Brief Title
    Efficacy and Safety of Kui-Yuan Chewable Tablets in Patients With Hyperuricemia
    Official Title
    A Randomized Controlled Study of Kui-Yuan Chewable Tablets in the Treatment of Hyperuricemia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    July 2023 (Anticipated)
    Primary Completion Date
    July 2024 (Anticipated)
    Study Completion Date
    August 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Quan Jiang

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hyperuricemia
    Keywords
    Hyperuricemia, Kui-Yuan Chewable, Randomized controlled trial

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    126 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Kui-Yuan Chewable Tablets
    Arm Type
    Active Comparator
    Arm Title
    Placebo of Kui-Yuan Chewable Tablets
    Arm Type
    Placebo Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    Kui-Yuan Chewable Tablets
    Intervention Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    Placedo of Kui-Yuan Chewable Tablets
    Intervention Description
    Placedo of Kui-Yuan Chewable Tablets are composed of L-arabinose, food starch and a few auxiliary materials.
    Primary Outcome Measure Information:
    Title
    Proportion of sUA levels below 420 μmol/L
    Description
    Proportion of participants maintaining sUA levels below 420 μmol/L at the third month
    Time Frame
    3 months
    Secondary Outcome Measure Information:
    Title
    Proportion of sUA levels below 360 μmol/L
    Description
    Proportion of participants maintaining sUA levels below 360 μmol/L at the third month
    Time Frame
    3 months
    Title
    The number of gout attacks
    Description
    The number of gout attacks from baseline to month 3
    Time Frame
    3 months
    Title
    Proportion of gout attacks
    Description
    Proportion of participants reporting gout attacks from baseline to month 3
    Time Frame
    3 months
    Title
    Percentage change in sUA levels
    Description
    Percentage change of participants in sUA levels from baseline to each visit
    Time Frame
    3 months
    Title
    Changes in BMI
    Description
    Changes in participants' BMI from baseline to the third month (combined with obesity)
    Time Frame
    3 months
    Title
    Changes in blood pressure levels
    Description
    Changes in participants' blood pressure levels from baseline to the third month (combined with hypertension)
    Time Frame
    3 months
    Title
    Changes in blood lipid levels
    Description
    Changes in participants' blood lipid levels from baseline to the third month (combined with hyperlipidemia)
    Time Frame
    3 months
    Title
    Changes in fasting blood glucose levels
    Description
    Changes in participants' fasting blood glucose levels from baseline to the third month (combined with diabetes)
    Time Frame
    3 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Quan Jiang, M.D
    Phone
    +8613901081632
    Email
    doctorjq@126.com

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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

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