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

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.

Study Overview

• Status: Unknown
• Conditions: Acute Gouty Arthritis
• Intervention / Treatment: 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; Drug: diclofenac sodium enteric-coated

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Wang Shi Dong, Doctor; Phone Number: 13910965659; Email: wsd3122@sina.cn
• Study Contact Backup: Name: Wu Wen Jing, Master; Phone Number: 15201218433; Email: anna861029@163.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100029
      • Recruiting
      • No.3 Hospital Affiliated to Beijing University of Chinese Medicine
      • Contact: Lou Xi Nen, Doctor; Phone Number: 13601181885; Email: 13601181885@163.com
    • Beijing, Beijing, China, 100700
      • Recruiting
      • Dongzhimen Hospital affiliated to Beijing University of Chinese Medicine
      • Contact: Zhao Jiu Li, Doctor; Phone Number: 84013229; Email: dzmk@163.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: treatment group; 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; Ingredient:cortex phellodendrine, rhizoma atractylodis, radix cyathula, coix seed, cotton Bi Xie,rhizoma smilacis glabrae; Drug: 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; Drug: Wet wrapping medicine of descending turbid and clearing heat; Ingredient:turmeric, rhubarb, cortex phellodendrine, rhizoma atractylodis, rhizoma arisaema, angelica dahurica, pseudobulbus cremastrae seu pleiones.
Active Comparator: Control group; Take diclofenac sodium enteric-coated, 50 mg, three times a day, continuous treatment for 10 days.	Drug: diclofenac sodium enteric-coated

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
The dosage of colchicine of two groups in observation period	The unit of measure is mg.	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
Erythrocyte sedimentation rate before and after the treatment.		After take the drug 10 days

Collaborators and Investigators

• Sponsor: Beijing University of Chinese Medicine

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (Anticipated): December 1, 2015

Study Registration Dates

• First Submitted: September 2, 2015
• First Submitted That Met QC Criteria: September 9, 2015
• First Posted (Estimate): September 10, 2015

Study Record Updates

• Last Update Posted (Estimate): September 11, 2015
• Last Update Submitted That Met QC Criteria: September 10, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Keywords: Acute gouty arthritis; tonifying spleen and descending the turbid; soaking; wet wrapping
• Additional Relevant MeSH Terms: Metabolic Diseases; Genetic Diseases, Inborn; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Metabolism, Inborn Errors; Crystal Arthropathies; Purine-Pyrimidine Metabolism, Inborn Errors; Gout; Arthritis; Arthritis, Gouty; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Diclofenac
• Other Study ID Numbers: 2015-ZYLC-001