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

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ClinicalTrials.gov Identifier: NCT02545777
Recruitment Status : Unknown
Verified September 2015 by Wang Shidong, Beijing University of Chinese Medicine.
Recruitment status was:  Recruiting
First Posted : September 10, 2015
Last Update Posted : September 11, 2015
Sponsor:
Information provided by (Responsible Party):
Wang Shidong, Beijing University of Chinese Medicine

Tracking Information
First Submitted Date  ICMJE September 2, 2015
First Posted Date  ICMJE September 10, 2015
Last Update Posted Date September 11, 2015
Study Start Date  ICMJE May 2014
Estimated Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 9, 2015)
  • 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 Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 9, 2015)
  • 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 Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Clinical Study on Treating Acute Gouty Arthritis Using Both Internal and External Therapy of Tonifying Spleen and Descending Turbid
Official Title  ICMJE Not Provided
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 Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Acute Gouty Arthritis
Intervention  ICMJE
  • Drug: diclofenac sodium enteric-coated
  • Drug: Oral medicine of tonifying spleen and descending turbid
    Ingredient:cortex phellodendrine, rhizoma atractylodis, radix cyathula, coix seed, cotton Bi Xie,rhizoma smilacis glabrae
  • Drug: Steeping and washing medicine of descending turbid and clearing heat
    Ingredient: turmeric, rhubarb, cortex phellodendrine, rhizoma atractylodis, rhizoma arisaema, angelica dahurica,garden balsam stem, pseudobulbus cremastrae seu pleiones
  • Drug: Wet wrapping medicine of descending turbid and clearing heat
    Ingredient:turmeric, rhubarb, cortex phellodendrine, rhizoma atractylodis, rhizoma arisaema, angelica dahurica, pseudobulbus cremastrae seu pleiones.
Study Arms  ICMJE
  • Active Comparator: treatment group
    Take oral medicine of tonifying spleen and descending turbid, one bag each time, two times a day, continuous treatment for 10 days.The onset of the joints afford steeping washing and wet wrapping medicine of descending turbid and clearing heat, once per day, continuous treatment for 10 days.
    Interventions:
    • Drug: Oral medicine of tonifying spleen and descending turbid
    • Drug: Steeping and washing medicine of descending turbid and clearing heat
    • Drug: Wet wrapping medicine of descending turbid and clearing heat
  • Active Comparator: Control group
    Take diclofenac sodium enteric-coated, 50 mg, three times a day, continuous treatment for 10 days.
    Intervention: Drug: diclofenac sodium enteric-coated
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: September 9, 2015)
120
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Aged 18-75, and gender unlimited;
  2. The patients must meet western medicine diagnostic criteria for acute gouty arthritis;
  3. The patients must meet that integral syndrome differentiation conforms to the spleen beset by dampness syndrome and local syndrome differentiation conforms to blockage disease due to heat.

Exclusion Criteria:

  1. Secondary hyperuricemia, such as cancer and perichemotherapy of leukemia, renal failure, cirrhosis of the liver and drug effect(such as diuretics, aspirin, antitubercular agents), et al.
  2. Acute infectious diseases, stroke, acute myocardial infarction ,as well as other acute diseases and tumors, rheumatoid arthritis.
  3. Patients with peptic ulcer and gastrointestinal bleeding.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02545777
Other Study ID Numbers  ICMJE 2015-ZYLC-001
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Wang Shidong, Beijing University of Chinese Medicine
Study Sponsor  ICMJE Beijing University of Chinese Medicine
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Beijing University of Chinese Medicine
Verification Date September 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP