Clinical trial NCT02545777: The Clinical Study on Treating Acute Gouty Arthritis Using Both Internal and External Therapy of Tonifying Spleen and Descending Turbid
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Acute Gouty Arthritis
Keywords: Acute gouty arthritis
tonifying spleen and descending the turbid
soaking
wet wrapping
Lead sponsor: Beijing University of Chinese Medicine
Sponsor class: OTHER
First posted: 2015-09-10
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: The relief of symptoms
timeFrame: After take the drug 10 days
measure: The gout relief index
timeFrame: After take the drug 10 days
measure: Compare scores of syndrome before treatment and after it.
timeFrame: After take the drug 10 days
Secondary outcomes:
measure: Recurrence rate
timeFrame: Following up for 1 month
measure: Recurrence time
timeFrame: Following up for 1 month
measure: The dosage of colchicine of two groups in observation period
timeFrame: After take the drug 10 days
measure: Blood uric acid before and after the treatment.
timeFrame: After take the drug 10 days
measure: White blood cell count before and after the treatment.
timeFrame: After take the drug 10 days
measure: Erythrocyte sedimentation rate before and after the treatment.
timeFrame: After take the drug 10 days
Other outcomes:
Locations:
city: Beijing
country: China
facility: No.3 Hospital Affiliated to Beijing University of Chinese Medicine
state: Beijing
city: Beijing
country: China
facility: Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine
state: Beijing
Study officials:
References: