Traditional Chinese Medicine in the Treatment of Patients With Hyperuricemia. A Randomized Placebo-Controlled Double-Blinded Clinical Trial.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 主要终点
- Serum Uric Acid<6 mg/dL at Week 4
研究概览
简要总结
To testify the efficacy and safety of traditional Chinese formulae, "Wu-Ling San" and "Yin-Chen Wu-Ling San" for patients with hyperuricemia.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •serum uric acid > 8 mg/dL
排除标准
- •gout attack within 2 weeks before baseline
- •drug for control urine acid must be stable dose within 2 weeks before baseline (e.g.allopurinol、benzbromarone、probenecid、sulfinpyrazone)
- •subject taking the drug involved azathioprine、aspirin (>325 mg)、atorvastatin、fenofibrate、losartan、thiazide、systemic corticosteroid、estrogen、oral contraceptive pills
- •serum creatinine > 3.0 mg/dL
- •GPT > 100 mg/dL
- •Pregnant or breast-feeding women
- •Chemotherapy or radiation therapy in cancer patients
研究组 & 干预措施
Placebo
Drug : 1/10 Wu Ling San
干预措施: Placebo (Drug)
Wu Ling San
Drug : Wu Ling San Extract Granules "Sun-Ten"
干预措施: Wu Ling San (Drug)
Yin-Chen Wu Ling San
Drug : Yin-Chen-Wu-Ling-San Extract Power "SUN-TEN"
干预措施: Yin-Chen Wu Ling San (Drug)
结局指标
主要结局
Serum Uric Acid<6 mg/dL at Week 4
时间窗: week 4
The number of patient serum uric acid \<6 mg/dL at week 4
次要结局
- Change From Baseline Serum Uric Acid at Week 2(week 0, week 2)
- Change From Baseline Serum Uric Acid at Week 8(week 0, week 8)
- Change From Baseline Blood Sugar at Week 4(week 0, week 4)
研究者
Cheng-Chung Wei
Professor
Chung Shan Medical University
