Traditional Chinese Medicine in the Treatment of Patients With Hyperuricemia.

Hyperuricemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04144088
• Other study ID #: CS05082
• Status: Completed
• Phase: Phase 2
• Start date: June 1, 2006
• Est. completion date: June 30, 2007

Study information

• Verified date: October 2019
• Source: Chung Shan Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 30, 2007
• Est. primary completion date: June 30, 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Hyperuricemia

Intervention

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.
• 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
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Chung Shan Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum Uric Acid<6 mg/dL at Week 4	The number of patient serum uric acid <6 mg/dL at week 4	week 4
Secondary	Change From Baseline Serum Uric Acid at Week 2	The investigators use serum uric acid to compared the difference between the week 2 and week 0	week 0, week 2
Secondary	Change From Baseline Serum Uric Acid at Week 8	The investigators use serum uric acid to compared the difference between the week 8 and week 0	week 0, week 8
Secondary	Change From Baseline Blood Sugar at Week 4	The investigators use blood sugar to compared the difference between the week 4 and week 0	week 0, week 4