Efficacy and Safety of HuZhen Capsule for Treatment of Patients With Acute Gout
NCT02674776 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 480
Last updated 2016-06-20
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.
Conditions
- Acute Gout
Interventions
- 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.
Sponsors & Collaborators
-
Quan Jiang
lead OTHER
Principal Investigators
-
Jiang Quan, Doctor · Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2015-09-30
- Primary Completion
- 2016-12-31
- Completion
- 2017-06-30
Countries
- China
Study Locations
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