Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 10:20 PM
Ignite Modification Date:
2025-12-26 @ 10:20 PM
NCT ID:
NCT05499312
Eligibility Criteria:
Inclusion Criteria:
1. Patient meeting the American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) 2015 gout classification criteria (met sufficient criterion\* or total score ≥8) ;
2. History of \>=1 self-reported flare of gouty arthritis within 12 months prior to randomization;
3. Agree to undergo blood test and willing to complete questionnaires and take medications as scheduled; and
4. Agree to participate in the study and provide written informed consent. (for those illiterate subjects, their family member can sign the consent form upon subject's agreement) Note: \* Sufficient criterion = Presence of MSU crystals in a symptomatic joint or bursa (i.e., in synovial fluid) or tophus
Exclusion Criteria:
1. Liver-kidney yin deficiency pattern according to Chinese medicine theory;
2. Use of urate-lowering drugs within 2 weeks prior to screening;
3. Present of tophi or known history of kidney stones.
4. Known use of oral/injectable corticosteroids or other Chinese herbal medicine for treating gout within 1 month prior to screening;
5. Ongoing acute gout arthritis flare at screening or within 2 weeks prior to screening;
6. History of \>4 flares overall in the 12 months prior to screening.
7. Polyarticular gouty arthritis involving more than 4 joints;
8. Severe deformity, stiffness and labor loss of patients with advanced arthritis;
9. Known rheumatoid arthritis, evidence/suspicion of infectious/septic arthritis, or other acute inflammatory arthritis;
10. Known history of any serious diseases such as severe kidney and liver impairments, autoimmune disease, thyroid disease, Hodgkin's disease, lymphoma, severe mental disorders and leukemia
11. Known presence or suspicion of acute infectious disease;
12. Known history of malignancy within the past 5 years;
13. Known allergic to the drug used in this study;
14. Documented pregnant or lactation;
15. Subjects participating in other clinical studies at the same time.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT05499312
Study Brief:
Protocol Section:
NCT05499312