Acute Gouty Arthritis
Conditions
Keywords
Acute gouty arthritis, tonifying spleen and descending the turbid, soaking, wet wrapping
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.
Interventions
DRUGdiclofenac sodium enteric-coated
DRUGOral medicine of tonifying spleen and descending turbid
Ingredient:cortex phellodendrine, rhizoma atractylodis, radix cyathula, coix seed, cotton Bi Xie,rhizoma smilacis glabrae
DRUGSteeping 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
DRUGWet wrapping medicine of descending turbid and clearing heat
Ingredient:turmeric, rhubarb, cortex phellodendrine, rhizoma atractylodis, rhizoma arisaema, angelica dahurica, pseudobulbus cremastrae seu pleiones.
Sponsors
Beijing University of Chinese Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The relief of symptoms | 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 | 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. | 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
| Measure | Time frame | Description |
|---|---|---|
| Blood uric acid before and after the treatment. | After take the drug 10 days | — |
| Recurrence rate | 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. |
| Erythrocyte sedimentation rate 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 | — |
| Recurrence time | 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 | After take the drug 10 days | The unit of measure is mg. |
Countries
China
Contacts
Primary ContactWang Shi Dong, Doctor
Backup ContactWu Wen Jing, Master
Outcome results
None listed