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
About this trial
This is an interventional basic science trial for Hyperuricemia
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
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
NCT ID
NCT04144088
First Posted
October 28, 2019
Last Updated
November 15, 2019
Sponsor
Chung Shan Medical University
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.
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