NCT02674776

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 480 (estimated)
• Sponsor: Quan Jiang · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Acute Gout

Interventions

Type	Name	Description
DRUG	HuZhen Capsule	Patients should take 4 tablet once and 3 times per day for 3 days.
DRUG	Placebo Capsule	Patients should take 4 tablet once and 3 times per day for 3 days.

Timeline

• Start date: 2015-09-01
• Primary completion: 2016-12-01
• Completion: 2017-06-01
• First posted: 2016-02-04
• Last updated: 2016-06-20

Locations

1 site across 1 country: China