Traditional Chinese Medicine in the Treatment of Patients With Hyperuricemia.

Phase 2

Completed

• Conditions: Hyperuricemia
• Interventions: Drug: Placebo; Drug: Yin-Chen Wu Ling San; Drug: Wu Ling San

• Registration Number: NCT04144088
• Lead Sponsor: Chung Shan Medical University

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.

Study Timeline

• Study Start: 2006-06-01
• Primary Completion: 2007-06-30
• Study Completion: 2007-06-30
• Status Verified: 2019-10
• Study First Submitted: 2019-10-28
• Study First Submitted QC: 2019-10-28
• Study First Posted: 2019-10-30
• Results First Submitted: 2019-11-15
• Results First Submitted QC: 2019-11-15
• Last Update Submitted: 2019-11-15
• Results First Posted: 2019-12-06
• Last Update Posted: 2019-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Drug : 1/10 Wu Ling San
Yin-Chen Wu Ling San	Yin-Chen Wu Ling San	Drug : Yin-Chen-Wu-Ling-San Extract Power "SUN-TEN"
Wu Ling San	Wu Ling San	Drug : Wu Ling San Extract Granules "Sun-Ten"

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Change From Baseline Serum Uric Acid at Week 2	week 0, 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	week 0, 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	week 0, week 4	The investigators use blood sugar to compared the difference between the week 4 and week 0