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

Phase 2

• Conditions: Acute Gouty Arthritis
• Interventions: Drug: Oral medicine of tonifying spleen and descending turbid; Drug: diclofenac sodium enteric-coated; Drug: Steeping and washing medicine of descending turbid and clearing heat; Drug: Wet wrapping medicine of descending turbid and clearing heat

• Registration Number: NCT02545777
• Lead Sponsor: Beijing University of Chinese Medicine

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-05
• Status Verified: 2015-09
• Study First Submitted: 2015-09-02
• Study First Submitted QC: 2015-09-09
• Study First Posted: 2015-09-10
• Last Update Submitted: 2015-09-10
• Last Update Posted: 2015-09-11
• Primary Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
treatment group	Wet wrapping medicine of descending turbid and clearing heat	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.
treatment group	Steeping and washing medicine of descending turbid and clearing heat	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.
treatment group	Oral medicine of tonifying spleen and descending turbid	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.
Control group	diclofenac sodium enteric-coated	Take diclofenac sodium enteric-coated, 50 mg, three times a day, continuous treatment for 10 days.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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
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

Trial Locations

Locations (2)

No.3 Hospital Affiliated to Beijing University of Chinese Medicine; 🇨🇳 Beijing, Beijing, China

Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine; 🇨🇳 Beijing, Beijing, China