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

Study Overview
=================
Brief 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.

Official Title
-----------------
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

Conditions
-----------------
Acute Gout

Intervention / Treatment
-----------------
* Drug: HuZhen Capsule
* Drug: Placebo Capsule


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Score is equal to or larger than 40cm on the 0-100cm VAS pain scale. Acute attack of gout no longer than 2 days. Participant with acute gout is diagnosed as damp-heat retention by Traditional Chinese medicine. Age 18-65 years with informed consent. Exclusion Criteria: Chronic gouty arthritis. Pseudogout, acute rheumatic fever and suppurative arthritis, traumatic arthritis, erysipelas, meander rheumatism and other arthritis. Anti-inflammatory medication for the treatment of acute gout. Pregnant or breastfeeding women. History of severe allergy, including diclofenac sodium. Serum creatinine is higher than the upper normal limit. ALT or AST is higher than the upper normal limit for two times. Fever ( T>38.5 ℃)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HuZhen Capsule<br>The main elements of HuZhen Capsule include Polygonum cuspidatum, Ligustrum lucidum etc. | Drug: HuZhen Capsule<br>* Patients should take 4 tablet once and 3 times per day for 3 days.<br>* Other names: capsule A;|
| Placebo Comparator: Placebo Capsule<br>Placebo appearance, content color and taste should be consistent with HuZhen Capsule. | Drug: Placebo Capsule<br>* Patients should take 4 tablet once and 3 times per day for 3 days.<br>* Other names: capsule B;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of VAS (visual analog scale) score from baseline to 72 Hours after onset |  | baseline,72 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of participants with improvement in acute gout at 72 hours post-dose using the criteria for the diagnosis of damp-heat retention | Refer to theGuidline for Clinical Study of New Chinese Medicines  | 72 hours | 
| Change in C-reactive protein (CRP) from baseline to 72 hours | Units of Measure:mg/L | baseline,72 hours | 
| Change in erythrocyte sedimentation rate ( ESR) from baseline to 72 hours | Units of Measure:mm/hour | baseline,72 hours | 
| Change in white blood cell count in whole blood cell analysis from baseline to 72 hours |  | baseline,72 hours | 
| The number of adverse events related to treatment |  | 72 hours |