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

Study Overview
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Brief Summary
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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.

Conditions
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Acute Gouty Arthritis

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 18-75, and gender unlimited; The patients must meet western medicine diagnostic criteria for acute gouty arthritis; 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: 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. Acute infectious diseases, stroke, acute myocardial infarction ,as well as other acute diseases and tumors, rheumatoid arthritis. Patients with peptic ulcer and gastrointestinal bleeding.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: treatment group<br>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<br>* Ingredient:cortex phellodendrine, rhizoma atractylodis, radix cyathula, coix seed, cotton Bi Xie,rhizoma smilacis glabrae<br>Drug: Steeping and washing medicine of descending turbid and clearing heat<br>* Ingredient: turmeric, rhubarb, cortex phellodendrine, rhizoma atractylodis, rhizoma arisaema, angelica dahurica,garden balsam stem, pseudobulbus cremastrae seu pleiones<br>Drug: Wet wrapping medicine of descending turbid and clearing heat<br>* Ingredient:turmeric, rhubarb, cortex phellodendrine, rhizoma atractylodis, rhizoma arisaema, angelica dahurica, pseudobulbus cremastrae seu pleiones.<br>|
| Active Comparator: Control group<br>Take diclofenac sodium enteric-coated, 50 mg, three times a day, continuous treatment for 10 days. | Drug: diclofenac sodium enteric-coated<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The relief of symptoms | 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. | After take the drug 10 days | 
| The gout relief index | The gout relief index = [gout relief time (days) ÷ 10 (days)] x 100%.The unit of measure is scale. | After take the drug 10 days | 
| Compare scores of syndrome before treatment and after it. | 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. | After take the drug 10 days | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute gouty arthritis, tonifying spleen and descending the turbid, soaking, wet wrapping