The Clinical Study on Treating Acute Gouty Arthritis Using Both Internal and External Therapy of Tonifying Spleen and Descending Turbid

Acute Gouty Arthritis Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02545777
• Other study ID #: 2015-ZYLC-001
• Status: Recruiting
• Phase: Phase 2
• First received: September 2, 2015
• Last updated: September 10, 2015
• Start date: May 2014

Study information

• Verified date: September 2015
• Source: Beijing University of Chinese Medicine
• Contact: Wang Shi Dong, Doctor
• Phone: 13910965659
• Email: wsd3122[@]sina.cn
• Is FDA regulated: No
• Health authority: China:Beijing University of Chinese Medicine
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Gouty Arthritis
• Arthritis
• Arthritis, Gouty

Intervention

Drug:
• diclofenac sodium enteric-coated

• Oral medicine of tonifying spleen and descending turbid
Ingredient:cortex phellodendrine, rhizoma atractylodis, radix cyathula, coix seed, cotton Bi Xie,rhizoma smilacis glabrae
• Steeping 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
• Wet wrapping medicine of descending turbid and clearing heat
Ingredient:turmeric, rhubarb, cortex phellodendrine, rhizoma atractylodis, rhizoma arisaema, angelica dahurica, pseudobulbus cremastrae seu pleiones.

Locations

Country	Name	City	State
China	Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine	Beijing	Beijing
China	No.3 Hospital Affiliated to Beijing University of Chinese Medicine	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing University of Chinese Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	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	No
Secondary	Recurrence time	Compare the days of cases recurring acute gouty arthritis of each group.The unit of measure is days.	Following up for 1 month	No
Secondary	The dosage of colchicine of two groups in observation period	The unit of measure is mg.	After take the drug 10 days	No
Secondary	Blood uric acid before and after the treatment.		After take the drug 10 days	No
Secondary	White blood cell count before and after the treatment.		After take the drug 10 days	No
Secondary	Erythrocyte sedimentation rate before and after the treatment.		After take the drug 10 days	No