Traditional Chinese Medicine in the Treatment of Patients With Hyperuricemia.
关键词
抽象
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.
日期
| 最后验证: | 09/30/2019 |
| 首次提交: | 10/27/2019 |
| 提交的预估入学人数: | 10/27/2019 |
| 首次发布: | 10/29/2019 |
| 上次提交的更新: | 11/14/2019 |
| 最近更新发布: | 12/05/2019 |
| 首次提交结果的日期: | 11/14/2019 |
| 首次提交质量检查结果的日期: | 11/14/2019 |
| 首次发布结果的日期: | 12/05/2019 |
| 实际学习开始日期: | 05/31/2006 |
| 预计主要完成日期: | 06/29/2007 |
| 预计完成日期: | 06/29/2007 |
状况或疾病
干预/治疗
Drug: Wu Ling San
Drug: Yin-Chen Wu Ling San
Drug: Placebo
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| Active Comparator: Wu Ling San Drug : Wu Ling San Extract Granules "Sun-Ten" | Drug: Wu Ling San 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. |
| Active Comparator: Yin-Chen Wu Ling San Drug : Yin-Chen-Wu-Ling-San Extract Power "SUN-TEN" | Drug: Yin-Chen Wu Ling San 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. |
| Placebo Comparator: Placebo Drug : 1/10 Wu Ling San | Drug: Placebo 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. |
资格标准
| 有资格学习的年龄 | 18 Years 至 18 Years |
| 有资格学习的性别 | All |
| 接受健康志愿者 | 是 |
| 标准 | 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 |
结果
主要结果指标
1. Serum Uric Acid<6 mg/dL at Week 4 [week 4]
次要成果指标
1. Change From Baseline Serum Uric Acid at Week 2 [week 0, week 2]
2. Change From Baseline Serum Uric Acid at Week 8 [week 0, week 8]
3. Change From Baseline Blood Sugar at Week 4 [week 0, week 4]
