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

Beijing University of Chinese Medicine

Status and phase: Unknown; Phase 2

Conditions: Acute Gouty Arthritis

Treatments: Drug: Steeping and washing medicine of descending turbid and clearing heat; Drug: Oral medicine of tonifying spleen and descending turbid; Drug: Wet wrapping medicine of descending turbid and clearing heat; Drug: diclofenac sodium enteric-coated

Study type: Interventional

Funder types: Other

Identifiers

NCT02545777

2015-ZYLC-001

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

120 participants in 2 patient groups

treatment group

Active Comparator group

Description:

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:

Drug: Wet wrapping medicine of descending turbid and clearing heat

Drug: Oral medicine of tonifying spleen and descending turbid

Drug: Steeping and washing medicine of descending turbid and clearing heat

Control group

Active Comparator group

Description:

Take diclofenac sodium enteric-coated, 50 mg, three times a day, continuous treatment for 10 days.

Treatment:

Drug: diclofenac sodium enteric-coated