Phase 2 N=60 Randomized Triple-blind Basic Science

Traditional Chinese Medicine in the Treatment of Patients With Hyperuricemia.

Hyperuricemia

Bottom Line

View on ClinicalTrials.gov: NCT04144088 ↗

Enrolled (actual)

Serious AEs

1.7%

Results posted

Dec 2019

Primary outcome: Primary: Serum Uric Acid<6 mg/dL at Week 4 — 0; 1; 1 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Wu Ling San (Drug); Yin-Chen Wu Ling San (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Chung Shan Medical University
Primary completion: Jun 2007

Outcome Measures

Outcome	Result	p-value
PRIMARY Serum Uric Acid<6 mg/dL at Week 4	0; 1; 1	—
SECONDARY Change From Baseline Serum Uric Acid at Week 2	—	—
SECONDARY Change From Baseline Serum Uric Acid at Week 8	—	—
SECONDARY Change From Baseline Blood Sugar at Week 4	—	—

Summary

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

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04144088). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.