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临床试验/NCT04144088
NCT04144088已完成2 期

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

Chung Shan Medical University0 个研究点目标入组 60 人开始时间: 2006年6月1日最近更新:
适应症
干预措施
相关药物

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

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

Placebo Comparator

Drug : 1/10 Wu Ling San

干预措施: Placebo (Drug)

Wu Ling San

Active Comparator

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

干预措施: Wu Ling San (Drug)

Yin-Chen Wu Ling San

Active Comparator

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Cheng-Chung Wei

Professor

Chung Shan Medical University

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