Traditional Chinese Medicine in the Treatment of Patients With Hyperuricemia.

Chung Shan Medical University

Status and phase: Completed; Phase 2

Conditions: Hyperuricemia

Treatments: Drug: Placebo; Drug: Yin-Chen Wu Ling San; Drug: Wu Ling San

Study type: Interventional

Funder types: Other

Identifiers

NCT04144088

CS05082

Details and patient eligibility

About

To testify the efficacy and safety of traditional Chinese formulae, "Wu-Ling San" and "Yin-Chen Wu-Ling San" for patients with hyperuricemia.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 3 patient groups, including a placebo group

Wu Ling San

Active Comparator group

Description:

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

Treatment:

Drug: Wu Ling San

Yin-Chen Wu Ling San

Active Comparator group

Description:

Drug : Yin-Chen-Wu-Ling-San Extract Power "SUN-TEN"

Treatment:

Drug: Yin-Chen Wu Ling San

Placebo

Placebo Comparator group

Description:

Drug : 1/10 Wu Ling San

Treatment:

Drug: Placebo