Traditional Chinese Medicine in the Treatment of Patients With Hyperuricemia.

Study Overview
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Brief Summary
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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
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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.

Official Title
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Traditional Chinese Medicine in the Treatment of Patients With Hyperuricemia. A Randomized Placebo-Controlled Double-Blinded Clinical Trial.

Conditions
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Hyperuricemia

Intervention / Treatment
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* Drug: Wu Ling San
* Drug: Yin-Chen Wu Ling San
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Wu Ling San<br>Drug : Wu Ling San Extract Granules Sun-Ten | Drug: Wu Ling San<br>* 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.<br>|
| Active Comparator: Yin-Chen Wu Ling San<br>Drug : Yin-Chen-Wu-Ling-San Extract Power SUN-TEN | Drug: Yin-Chen Wu Ling San<br>* 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.<br>|
| Placebo Comparator: Placebo<br>Drug : 1/10 Wu Ling San | Drug: Placebo<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum Uric Acid<6 mg/dL at Week 4 | The number of patient serum uric acid <6 mg/dL at week 4 | week 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | week 0, week 2 | 
| 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 | week 0, week 8 | 
| Change From Baseline Blood Sugar at Week 4 | The investigators use blood sugar to compared the difference between the week 4 and week 0 | week 0, week 4 |