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

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

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

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 Summary: 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.
Sponsor: Quan Jiang

Current Primary Outcome: Change of VAS (visual analog scale) score from baseline to 72 Hours after onset [ Time Frame: baseline,72 hours ]

Original Primary Outcome: Change of VAS (visual analog scale) score from baseline at 72 Hours after onset [ Time Frame: 72 hours ]

Current Secondary Outcome:

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


Original Secondary Outcome:

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


Information By: Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Dates:
Date Received: January 28, 2016
Date Started: September 2015
Date Completion: June 2017
Last Updated: June 17, 2016
Last Verified: June 2016