Clinical trial: Efficacy and Safety of Simiaowan in Prevention of Acute Flares in Chronic Gout Patients Initiating Febuxostat Therapy (NCT04069325)

Eligibility criteria:
Inclusion Criteria:

          -  Male or female subjects aged 18 to 75 years (time of get informed consent)

          -  Meet the American College of Rheumatology/The European League Against Rheumatism
             criteria (2015) for the classification of acute arthritis of primary gout

          -  Pain Visual Analogue Scale Score (VAS) ≤ 3 at screening

          -  Serum uric acid ≥7 mg/dL (420μmol/L) at screening

          -  Self-reported history of at least 2 gout flares within 12 months prior to screening

          -  Normal electrocardiogram (ECG), or no clinical significant at screening

          -  Be capable of understanding and complying with protocol requirements

        Exclusion Criteria:

          -  Occurrence of an acute gout flare ongoing at screening or within 2 weeks prior to
             screening

          -  Known or suspected of secondary hyperuricemia (e.g. due to renal disorder,
             hematological disorder, drugs, radiotherapy, chemotherapy or organ transplant)

          -  Use of colchicine, allopurinol, probenecid, benzbromarone, febuxostat or history of
             intra-articular steroid injection within 4 weeks prior to screening

          -  Use of glucocorticoids, nonsteroidal antiinflammatory drugs (NSAIDs), or
             cyclooxygenase-2 (COX-2) inhibitors within 1 week prior to screening

          -  History of stroke, transient ischemic attack (TIA), acute myocardial infarction (MI),
             heart failure (NYHA Class II-IV), coronary intervention procedure (including but not
             limited to angioplasty, stent placement, coronary revascularization) prior to
             screening

          -  History of gastrointestinal (GI) bleeding, peptic ulcer disease prior to screening

          -  History of malignancy and/or mental disorder prior to screening

          -  Active infection with hepatitis B, hepatitis C, or has aspartate transaminase (AST),
             alanine aminotransferase (ALT) or gamma-glutamyl transpeptidase (GGT) values ≥1.2
             times the upper limit of normal (×ULN) during the screening period

          -  Presence of severe renal function impairment, or has serum creatinine (sCr) values
             ≥1.2 (×ULN) during the screening period

          -  History of allergy or intolerance to febuxostat, diclofenac sodium, simiaowan and/or
             the placebo

          -  History of aspirin-induced asthma, or any other form of allergy to aspirin and other
             NSAIDs

          -  Other (non-gout) chronic arthritis, acute inflammatory arthritis, autoimmune diseases
             with arthritis at screening

          -  Being treated with simiaowan at screening

          -  Being treated with azathioprine, mercaptopurine, theophylline, cytotoxic agents at
             screening

          -  Diagnosis of drug or alcohol dependence or abuse or any condition requiring chronic
             daily use of pain medication

          -  Pregnant or nursing, or planning to become pregnant or father a child within 3 months
             after receiving the last dose of study drug

          -  Subjects who participated in another clinical study or clinical trial within 3 months
             prior to screening

          -  Any other condition(s) that will compromise the safety of the patient, prevent
             compliance with the study protocol, or compromise the quality of the clinical study,
             as judged by the investigator
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 75 Years

Patient description (medical language): A 39-year-old man comes to the emergency department with an acute onset of severe left toe pain.  The toe is red and exhibits swelling. The patient is not febrile, and does not remember any recent trauma. Medical history is not significant except for the similar attacks and the diagnosis of gouty arthritis. His medication history includes Allopurinol to prevent gouty attacks. His father has the same medical condition. However, his older brother who is 41 years old is healthy with no history of gouty arthritis. Physical examination shows a swollen, tender first metatarsophalangeal joint.  Aspiration of the joint showed high leukocyte count, negative Gram stain, and numerous needle-shaped crystals, which is compatible with gouty arthritis.

Patient description (patient's own words): I'm a 39-year-old man and got admitted to the ER after an unbearable pain in my left toe. My toe was red and terribly swollen. I was still standing on my feet, not febrile and I don't remember hitting my head or anything. I don't have any special medical history, but I had been diagnosed with gout before. I take Lopurin to prevent my gouty attacks. My dad had the same problem, but my 41-year-old brother is healthy and does not have gouty attacks. The doctor did a physical exam and found that the joints between my toes and the rest of my foot were swollen and tender. The doctor renewed his diagnosis of gouty arthritis.

Does the patient match the trial criteria? Contradiction