Clinical Trial: The Clinical Study on Treating Acute Gouty Arthritis Using Both Internal and External Therapy of Tonifying Spleen and Descending Turbid

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title:

Brief Summary: This research is based on spleen trapped by dampness and turbid which is the pathogenesis of gouty arthritis.It uses effective prescription of Endocrinology of Dongzhimen Hospital.In this study, the investigators use multi-center randomized parallel controlled clinical trials.The treatment groups are afforded oral traditional Chinese medicine decoction-tonifying spleen and descending the turbid decoction as well as soaking and wet wrapping.The control groups are afforded diclofenac sodium enteric-coated tablets as a positive control drug.The outcome is evaluated by condition of symptoms remission,pain relief time, recurrence rate and laboratory index to determine the efficacy of internal and external treatment.And the research will provide optimized diagnosis and treatment program. The investigators hope this research will also get tonifying spleen and descending the turbid internal and external treatment for gouty arthritis effective clinical treatment.

Detailed Summary:
Sponsor: Beijing University of Chinese Medicine

Current Primary Outcome:

  • The relief of symptoms [ Time Frame: After take the drug 10 days ]
    This measure is a composite outcome according to the joint red and swollen, joint pain, and restricted movement(Excellent:Complete resolution of symptoms, joint function returning to normal. The score of joint pain, joint red and swollen and joint motion is 0.Effective:The main symptoms mostly disappear. Joint function is improvement, but still have the joint red,swollen,pain and limited activity.Invalid: There is no improvement compared with before treatment).The unit of measure is scale.
  • The gout relief index [ Time Frame: After take the drug 10 days ]
    The gout relief index = [gout relief time (days) ÷ 10 (days)] x 100%.The unit of measure is scale.
  • Compare scores of syndrome before treatment and after it. [ Time Frame: After take the drug 10 days ]
    Using nimodipine method: nimodipine = [(scores of syndrome before treatment minus score after it) ÷scores of syndrome before treatment] x 100%.The unit of measure is scale.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Recurrence rate [ Time Frame: Following up for 1 month ]
    Recurrence rate=number of patient recurring acute gouty arthritis ÷total cases of each group.The unit of measure is number.
  • Recurrence time [ Time Frame: Following up for 1 month ]
    Compare the days of cases recurring acute gouty arthritis of each group.The unit of measure is days.
  • The dosage of colchicine of two groups in observation period [ Time Frame: After take the drug 10 days ]
    The unit of measure is mg.
  • Blood uric acid before and after the treatment. [ Time Frame: After take the drug 10 days ]
  • White blood cell count before and after the treatment. [ Time Frame: After take the drug 10 days ]
  • Erythrocyte sedimentation rate before and after the treatment. [ Time Frame: After take the drug 10 days ]


Original Secondary Outcome: Same as current

Information By: Beijing University of Chinese Medicine

Dates:
Date Received: September 2, 2015
Date Started: May 2014
Date Completion:
Last Updated: September 10, 2015
Last Verified: September 2015