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

Last updated: June 17, 2016
Sponsor: Quan Jiang
Overall Status: Trial Status Unknown

Phase

3

Condition

Arthritis And Arthritic Pain (Pediatric)

Joint Injuries

Collagen Vascular Diseases

Treatment

N/A

Clinical Study ID

NCT02674776
2013003P3A03
  • Ages 18-65
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 TraditionalChinese medicine.

  4. Age 18-65 years with informed consent.

Exclusion

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 theupper normal limit for two times.

  7. Fever ( T>38.5 ℃)

Study Design

Total Participants: 480
Study Start date:
September 01, 2015
Estimated Completion Date:
June 30, 2017

Study 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.

Connect with a study center

  • Guang'anmen Hospital

    Bei Jing, Beijing 100052
    China

    Site Not Available

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