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

Quan Jiang

Status and phase: Unknown; Phase 3

Conditions: Acute Gout

Treatments: Drug: HuZhen Capsule; Drug: Placebo Capsule

Study type: Interventional

Funder types: Other

Identifiers

NCT02674776

2013003P3A03

Details and patient eligibility

About

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.

Full 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.

Enrollment: 480 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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 ℃)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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480 participants in 2 patient groups, including a placebo group

HuZhen Capsule

Experimental group

Description:

The main elements of HuZhen Capsule include Polygonum cuspidatum, Ligustrum lucidum etc.

Treatment:

Drug: HuZhen Capsule

Placebo Capsule

Placebo Comparator group

Description:

Placebo appearance, content color and taste should be consistent with HuZhen Capsule.

Treatment:

Drug: Placebo Capsule