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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| treatment group | Active Comparator | 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. |
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| Control group | Active Comparator | Take diclofenac sodium enteric-coated, 50 mg, three times a day, continuous treatment for 10 days. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| diclofenac sodium enteric-coated | Drug |
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| Oral medicine of tonifying spleen and descending turbid |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wang Shi Dong, Doctor | Contact | 13910965659 | wsd3122@sina.cn | |
| Wu Wen Jing, Master | Contact | 15201218433 | anna861029@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| No.3 Hospital Affiliated to Beijing University of Chinese Medicine | Recruiting | Beijing | Beijing Municipality | 100029 | China |
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| Drug |
Ingredient:cortex phellodendrine, rhizoma atractylodis, radix cyathula, coix seed, cotton Bi Xie,rhizoma smilacis glabrae |
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| Steeping and washing medicine of descending turbid and clearing heat | Drug | Ingredient: turmeric, rhubarb, cortex phellodendrine, rhizoma atractylodis, rhizoma arisaema, angelica dahurica,garden balsam stem, pseudobulbus cremastrae seu pleiones |
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| Wet wrapping medicine of descending turbid and clearing heat | Drug | Ingredient:turmeric, rhubarb, cortex phellodendrine, rhizoma atractylodis, rhizoma arisaema, angelica dahurica, pseudobulbus cremastrae seu pleiones. |
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| 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 |
| Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine | Recruiting | Beijing | Beijing Municipality | 100700 | China |
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