The Clinical Study on Treating Acute Gouty Arthritis Using Both Internal and External Therapy of Tonifying Spleen and Descending Turbid
1 other identifier
interventional
120
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2014
CompletedFirst Submitted
Initial submission to the registry
September 2, 2015
CompletedFirst Posted
Study publicly available on registry
September 10, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedSeptember 11, 2015
September 1, 2015
1.6 years
September 2, 2015
September 10, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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 Outcomes (6)
Recurrence rate
Following up for 1 month
Recurrence time
Following up for 1 month
The dosage of colchicine of two groups in observation period
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
- +1 more secondary outcomes
Study Arms (2)
treatment group
ACTIVE COMPARATORTake 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.
Control group
ACTIVE COMPARATORTake diclofenac sodium enteric-coated, 50 mg, three times a day, continuous treatment for 10 days.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
No.3 Hospital Affiliated to Beijing University of Chinese Medicine
Beijing, Beijing Municipality, 100029, China
Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine
Beijing, Beijing Municipality, 100700, China
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Beijing University of Chinese Medicine
Study Record Dates
First Submitted
September 2, 2015
First Posted
September 10, 2015
Study Start
May 1, 2014
Primary Completion
December 1, 2015
Last Updated
September 11, 2015
Record last verified: 2015-09