A Phase 2 interventional study of diclofenac sodium enteric-coated and Oral medicine of tonifying spleen and descending turbid in Acute Gouty Arthritis, sponsored by Beijing University of Chinese Medicine. Status unknown at 2 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2015-09-11.
Sponsored by Beijing University of Chinese Medicine · Phase 2, Interventional, and Treatment
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.
3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.
This study's planned enrollment of 120 is above the median of 90 across 2,377 interventional studies indexed under Arthritis.
Browse Arthritis studies →Beijing University of Chinese Medicine is the lead sponsor of 31 studies on the registry; 8 are open to participants now.
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Exclusion Criteria:
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 · Drug: Steeping and washing medicine of descending turbid and clearing heat · Drug: Wet wrapping medicine of descending turbid and clearing heat
Take diclofenac sodium enteric-coated, 50 mg, three times a day, continuous treatment for 10 days.
Drug: diclofenac sodium enteric-coated
Ingredient:cortex phellodendrine, rhizoma atractylodis, radix cyathula, coix seed, cotton Bi Xie,rhizoma smilacis glabrae
Ingredient: turmeric, rhubarb, cortex phellodendrine, rhizoma atractylodis, rhizoma arisaema, angelica dahurica,garden balsam stem, pseudobulbus cremastrae seu pleiones
Ingredient:turmeric, rhubarb, cortex phellodendrine, rhizoma atractylodis, rhizoma arisaema, angelica dahurica, pseudobulbus cremastrae seu pleiones.
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.
Time frame: 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.
Time frame: 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.
Time frame: After take the drug 10 days
Recurrence rate
Recurrence rate=number of patient recurring acute gouty arthritis ÷total cases of each group.The unit of measure is number.
Time frame: 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.
Time frame: Following up for 1 month
The dosage of colchicine of two groups in observation period
The unit of measure is mg.
Time frame: After take the drug 10 days
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
This study is status unknown, as verified in Sep 2015. You cannot join it, but the record below documents what was studied.
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Beijing University of Chinese Medicine