search
Back to results

Traditional Chinese Medicine in the Treatment of Patients With Hyperuricemia.

Primary Purpose

Hyperuricemia

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Wu Ling San
Yin-Chen Wu Ling San
Placebo
Sponsored by
Chung Shan Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Hyperuricemia

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • serum uric acid > 8 mg/dL

Exclusion Criteria:

  • 1. gout attack within 2 weeks before baseline 2. drug for control urine acid must be stable dose within 2 weeks before baseline (e.g.allopurinol、benzbromarone、probenecid、sulfinpyrazone) 3. subject taking the drug involved azathioprine、aspirin (>325 mg)、atorvastatin、fenofibrate、losartan、thiazide、systemic corticosteroid、estrogen、oral contraceptive pills 4. serum creatinine > 3.0 mg/dL 5. GPT > 100 mg/dL 6. Pregnant or breast-feeding women 7. Chemotherapy or radiation therapy in cancer patients

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Active Comparator

    Placebo Comparator

    Arm Label

    Wu Ling San

    Yin-Chen Wu Ling San

    Placebo

    Arm Description

    Drug : Wu Ling San Extract Granules "Sun-Ten"

    Drug : Yin-Chen-Wu-Ling-San Extract Power "SUN-TEN"

    Drug : 1/10 Wu Ling San

    Outcomes

    Primary Outcome Measures

    Serum Uric Acid<6 mg/dL at Week 4
    The number of patient serum uric acid <6 mg/dL at week 4

    Secondary Outcome Measures

    Change From Baseline Serum Uric Acid at Week 2
    The investigators use serum uric acid to compared the difference between the week 2 and week 0
    Change From Baseline Serum Uric Acid at Week 8
    The investigators use serum uric acid to compared the difference between the week 8 and week 0
    Change From Baseline Blood Sugar at Week 4
    The investigators use blood sugar to compared the difference between the week 4 and week 0

    Full Information

    First Posted
    October 28, 2019
    Last Updated
    November 15, 2019
    Sponsor
    Chung Shan Medical University
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT04144088
    Brief Title
    Traditional Chinese Medicine in the Treatment of Patients With Hyperuricemia.
    Official Title
    Traditional Chinese Medicine in the Treatment of Patients With Hyperuricemia. A Randomized Placebo-Controlled Double-Blinded Clinical Trial.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    June 1, 2006 (Actual)
    Primary Completion Date
    June 30, 2007 (Actual)
    Study Completion Date
    June 30, 2007 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Chung Shan Medical University

    4. Oversight

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

    5. Study Description

    Brief Summary
    To testify the efficacy and safety of traditional Chinese formulae, "Wu-Ling San" and "Yin-Chen Wu-Ling San" for patients with hyperuricemia.
    Detailed Description
    The prevalence of hyperuricemia and gout is increasing in Taiwan. It is probably contributed by adapting to Western diet and lifestyle. Previous studies have demonstrated the relationship between hyperuricemia with hypertension, metabolic syndrome, cardiovascular disease and chronic renal disease. While Western medicine shows promising effects in treating hyperuricemia and gout, we are searching for an alternative in traditional Chinese medicine with both safety and efficacy in treating hyperuricemia. We conducted a randomized double-blinded placebo-controlled clinical trial in adults with hyperuricemia. Sixty patients with serum uric acid level more than 8 mg/dl were enrolled. Patients were then randomized into three arms: Traditional Chinese Medicine formulae: "Wu-Ling San", "Yin-Chen Wu-Ling San" or placebo for 4 weeks. Efficacy and safety were evaluated at Week 2, 4 and 8. Primary endpoint was the serum uric acid<6 mg/dL at Week 4. Secondary endpoints were the differences between groups in serum uric acid at Week 2 and 8, serum SGPT, SGOT, creatinine, total cholesterol, triglycerides, HDL, LDL, fasting blood glucose, body weight, blood pressures and frequency of gouty attack at Week 4.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hyperuricemia

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    60 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Wu Ling San
    Arm Type
    Active Comparator
    Arm Description
    Drug : Wu Ling San Extract Granules "Sun-Ten"
    Arm Title
    Yin-Chen Wu Ling San
    Arm Type
    Active Comparator
    Arm Description
    Drug : Yin-Chen-Wu-Ling-San Extract Power "SUN-TEN"
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Drug : 1/10 Wu Ling San
    Intervention Type
    Drug
    Intervention Name(s)
    Wu Ling San
    Intervention Description
    assigned to Wu Ling San (n =20) and were instructed to take 4.5 gm 2 times per day of Wu Ling San for a period of 4 weeks.
    Intervention Type
    Drug
    Intervention Name(s)
    Yin-Chen Wu Ling San
    Intervention Description
    assigned to Yin-Chen Wu Ling San (n =20) and were instructed to take 4.5 gm 2 times per day of Yin-Chen Wu Ling San for a period of 4 weeks.
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    1/10 Wu Ling San assigned to Placebo (n =20) and were instructed to take 4.5 gm 2 times per day of Placebo for a period of 4 weeks.
    Primary Outcome Measure Information:
    Title
    Serum Uric Acid<6 mg/dL at Week 4
    Description
    The number of patient serum uric acid <6 mg/dL at week 4
    Time Frame
    week 4
    Secondary Outcome Measure Information:
    Title
    Change From Baseline Serum Uric Acid at Week 2
    Description
    The investigators use serum uric acid to compared the difference between the week 2 and week 0
    Time Frame
    week 0, week 2
    Title
    Change From Baseline Serum Uric Acid at Week 8
    Description
    The investigators use serum uric acid to compared the difference between the week 8 and week 0
    Time Frame
    week 0, week 8
    Title
    Change From Baseline Blood Sugar at Week 4
    Description
    The investigators use blood sugar to compared the difference between the week 4 and week 0
    Time Frame
    week 0, week 4

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: serum uric acid > 8 mg/dL Exclusion Criteria: 1. gout attack within 2 weeks before baseline 2. drug for control urine acid must be stable dose within 2 weeks before baseline (e.g.allopurinol、benzbromarone、probenecid、sulfinpyrazone) 3. subject taking the drug involved azathioprine、aspirin (>325 mg)、atorvastatin、fenofibrate、losartan、thiazide、systemic corticosteroid、estrogen、oral contraceptive pills 4. serum creatinine > 3.0 mg/dL 5. GPT > 100 mg/dL 6. Pregnant or breast-feeding women 7. Chemotherapy or radiation therapy in cancer patients
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Cheng Ching Wei, Ph. D.
    Organizational Affiliation
    Chung Shan Medical University
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Traditional Chinese Medicine in the Treatment of Patients With Hyperuricemia.

    We'll reach out to this number within 24 hrs