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

Phase 3

• Conditions: Acute Gout
• Interventions: Drug: Placebo Capsule; Drug: HuZhen Capsule

• Registration Number: NCT02674776
• Lead Sponsor: Quan Jiang

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.

Study Timeline

• Study Start: 2015-09
• Study First Submitted: 2016-01-28
• Study First Submitted QC: 2016-02-02
• Study First Posted: 2016-02-04
• Status Verified: 2016-06
• Last Update Submitted: 2016-06-17
• Last Update Posted: 2016-06-20
• Primary Completion: 2016-12
• Study Completion: 2017-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 480

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 ℃)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Capsule	Placebo Capsule	Placebo appearance, content color and taste should be consistent with HuZhen Capsule.
HuZhen Capsule	HuZhen Capsule	The main elements of HuZhen Capsule include Polygonum cuspidatum, Ligustrum lucidum etc.

Primary Outcome Measures

Name	Time	Method
Change of VAS (visual analog scale) score from baseline to 72 Hours after onset	baseline,72 hours

Secondary Outcome Measures

Name	Time	Method
Change in C-reactive protein (CRP) from baseline to 72 hours	baseline,72 hours	Units of Measure:mg/L
Change in erythrocyte sedimentation rate ( ESR) from baseline to 72 hours	baseline,72 hours	Units of Measure:mm/hour
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
Proportion of participants with improvement in acute gout at 72 hours post-dose using the criteria for the diagnosis of damp-heat retention	72 hours	Refer to the"Guidline for Clinical Study of New Chinese Medicines "

Trial Locations

Locations (1)

Guang'anmen Hospital; 🇨🇳 Bei Jing, Beijing, China