Hyperuricemia Clinical Trial
Official title:
Traditional Chinese Medicine in the Treatment of Patients With Hyperuricemia. A Randomized Placebo-Controlled Double-Blinded Clinical Trial.
To testify the efficacy and safety of traditional Chinese formulae, "Wu-Ling San" and "Yin-Chen Wu-Ling San" for patients with hyperuricemia.
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.
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