Efficacy and Safety of HuZhen Capsule for Treatment of Patients With Acute Gout

A Clinical Trial About the Efficacy and Safety of HuZhen Capsule in Treating Patients With Acute Gout: A 72 Hours, Multi-center, Randomized, Double-blind, Parallel Placebo Compared Clinical Trial

This study is a multi-center, double-blind, randomized, parallel controlled trial. Patients with acute gout will be enrolled and randomly allocated into 2 groups: HuZhen capsule treatment group and Placebo control group. Randomization codes were established by the biostatistician. Observe will be followed for 3 days (72 hours) after the onset. Change of VAS score from baseline, proportion of improvement with damp-heat retention, change in C-reactive protein (CRP) and erythrocyte sedimentation rate ( ESR) from baseline, change in white blood cell count in whole blood cell analysis from baseline, and the number of adverse events will be monitored and compared between each groups.

The test group will be given HuZhen capsule 1.6g three times per day,the control group will be given placebo 1.6g three times per day. The invention will last 3 days.

Inclusion Criteria:

1. Score is equal to or larger than 40cm on the 0-100cm VAS pain scale.
2. Acute attack of gout no longer than 2 days.
3. Participant with acute gout is diagnosed as "damp-heat retention" by Traditional Chinese medicine.
4. Age 18-65 years with informed consent.

Exclusion Criteria:

1. Chronic gouty arthritis.
2. Pseudogout, acute rheumatic fever and suppurative arthritis, traumatic arthritis, erysipelas, meander rheumatism and other arthritis.
3. Anti-inflammatory medication for the treatment of acute gout.
4. Pregnant or breastfeeding women.
5. History of severe allergy, including diclofenac sodium.
6. Serum creatinine is higher than the upper normal limit. ALT or AST is higher than the upper normal limit for two times.
7. Fever ( T>38.5 ℃)