Acute gouty arthritis
Conditions
Interventions
Test group:Niantong Qufeng granules+sodium bicarbonate tablets
Control group:Placebo granules+sodium bicarbonate tablets
Sponsors
The Affiliated Hospital of Chengdu University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1) Diagnostic Criteria: Participants met both the Western diagnostic criteria for acute gouty arthritis and the Traditional Chinese Medicine (TCM) syndrome differentiation criteria for rheumatism stagnation and heat syndrome. 2) Age Range: Participants aged between 18 and 70 years, irrespective of gender. 3) Acute Flare Period: Participants experienced an acute gout flare, with the time between symptom onset and randomisation not exceeding 48 hours. 4) Joint Pain Intensity: A minimum joint pain intensity score of 5 points on the visual analogue scale (ranging from 0 to 10 points). 5) Voluntary Participation: Willingness to voluntarily participate in the trial, including signing an informed consent form indicating agreement to adhere to the medication regimen as stipulated by the study protocol and undergo the required evaluations.
Exclusion criteria
Exclusion criteria: 1) Secondary Causes: Presence of secondary gout or arthropathy resulting from other conditions (e.g., rheumatic arthritis, pyogenic arthritis, traumatic arthritis, senile osteoarthritis, pseudogout, chemotherapy, radiotherapy, chronic lead poisoning, or acute obstructive nephropathy). 2) Chronic Gout Forms: Patients with chronic intermittent gout or chronic tophaceous gout. 3) Advanced Impairments: Individuals with advanced deformities, disabilities, labour loss, or cardiovascular diseases induced by pain. 4) Medication Influence: Patients taking medications affecting blood uric acid (UA) metabolism, such as hydrochlorothiazide, furosemide, low-dose aspirin, or drugs containing these components, including compound antihypertensive tablets. Patients who had used glucocorticosteroids within 1 month before enrolment or those using non-steroidal anti-inflammatory drugs (NSAIDs) or other analgesic drugs within 48 hours before the baseline assessment. 5) Pregnancy and Breastfeeding: Women who were pregnant, preparing for pregnancy, or currently breastfeeding. 6) Serious Comorbidities: Patients with severe cardiovascular, hepatic, renal, haematological, pulmonary disorders, or other critical illnesses impacting survival, such as tumours or AIDS. 7) Abnormal Laboratory Values: Elevated ALT levels exceeding twice the upper limit of normal, serum creatinine (Cr) levels surpassing the upper reference limit, urine protein exceeding the norm (greater than '+'), or clinically significant arrhythmias. 8) Active Ulcers: Presence of active, non-resolving ulcers or use of anti-ulcer medications. 9) Mental or Legal Disabilities: Patients with mental or legal incapacities. 9) Substance Abuse or Complicating Conditions: Suspected or documented history of alcohol or drug abuse, or other medical conditions that, in the investigator's judgement, would hinder or complicate enrolment, e.g., frequent job changes leading to missed visits. 10) Hypersensitivity: Known hypersensitivity to any components of the medication. 11) Recent Clinical Trials: Participation in other clinical research studies within 3 months preceding enrolment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to disappearance of joint pain; | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in joint pressure pain score after treatment;Change in joint swelling score after treatment;Time to 30% reduction in VAS pain score;Time to 50% reduction in VAS pain score;Change in VAS score after treatment;Time to relief of joint pain;The efficacy of Chinese medicine symptoms;Patient's evaluation of the overall treatment effect at the end of the treatment.;Changes in laboratory indicators (blood uric acid, C-reactive protein, blood sedimentation).; | — |
Countries
China
Contacts
Public ContactYuan Li
The Affiliated Hospital of Chengdu University of Traditional Chinese Medicine
Outcome results
None listed