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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

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.

Condition or disease Intervention/treatment Phase
Acute Gouty Arthritis Drug: diclofenac sodium enteric-coated 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 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : May 2014
Estimated Primary Completion Date : December 2015

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Gout
MedlinePlus related topics: Arthritis

Arm Intervention/treatment
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.
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.

Active Comparator: Control group
Take diclofenac sodium enteric-coated, 50 mg, three times a day, continuous treatment for 10 days.
Drug: diclofenac sodium enteric-coated



Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. The dosage of colchicine of two groups in observation period [ Time Frame: After take the drug 10 days ]
    The unit of measure is mg.

  4. Blood uric acid before and after the treatment. [ Time Frame: After take the drug 10 days ]
  5. White blood cell count before and after the treatment. [ Time Frame: After take the drug 10 days ]
  6. Erythrocyte sedimentation rate before and after the treatment. [ Time Frame: After take the drug 10 days ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02545777


Contacts
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Contact: Wang Shi Dong, Doctor 13910965659 wsd3122@sina.cn
Contact: Wu Wen Jing, Master 15201218433 anna861029@163.com

Locations
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China, Beijing
No.3 Hospital Affiliated to Beijing University of Chinese Medicine Recruiting
Beijing, Beijing, China, 100029
Contact: Lou Xi Nen, Doctor    13601181885    13601181885@163.com   
Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine Recruiting
Beijing, Beijing, China, 100700
Contact: Zhao Jiu Li, Doctor    84013229    dzmk@163.net   
Sponsors and Collaborators
Beijing University of Chinese Medicine

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Responsible Party: Wang Shidong, Beijing University of Chinese Medicine
ClinicalTrials.gov Identifier: NCT02545777     History of Changes
Other Study ID Numbers: 2015-ZYLC-001
First Posted: September 10, 2015    Key Record Dates
Last Update Posted: September 11, 2015
Last Verified: September 2015

Keywords provided by Wang Shidong, Beijing University of Chinese Medicine:
Acute gouty arthritis
tonifying spleen and descending the turbid
soaking
wet wrapping

Additional relevant MeSH terms:
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Arthritis
Arthritis, Gouty
Joint Diseases
Musculoskeletal Diseases
Gout
Crystal Arthropathies
Rheumatic Diseases
Purine-Pyrimidine Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Metabolic Diseases
Diclofenac
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action