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:
2025-12-24 @ 4:58 PM
Ignite Modification Date:
2025-12-24 @ 4:58 PM
NCT ID:
NCT05393050
Eligibility Criteria:
Inclusion Criteria:
1. Subject understood the whole process of the trial and signed the informed consent voluntarily.
2. Subject has had a confirmed diagnosis of rheumatoid arthritis according to 2010 ACR/EULAR RA classification criteria.
3. Subjects aged between 45-70years who were the males without fertility requirements or menopausal women.
4. Subject has a DAS28 CRP disease activity score greater than 2.6 and less than 5.1.
5. Subject did not participate in any drug trials within 1 month before enrollment.
Exclusion Criteria:
1. Pregnant women, women planning to become pregnant or breastfeeding.
2. Severe systemic involvement, such as severe pericardial effusion, interstitial lung disease, renal tubular acidosis, autoimmune liver disease.
3. Active liver disease or abnormal liver function, ALT and AST are more than 1.5 times the upper limit of normal.
4. Renal impairment, serum creatinine greater than the upper limit of normal.
5. Bone marrow hematopoietic dysfunction, peripheral blood leukocytes \<3.0×109/L, or definite anemia (hemoglobin less than 80g/L), or platelets \<80×109/L, or other blood system diseases.
6. Active gastric and duodenal ulcers.
7. Uncontrolled severe hypertension, metabolic diseases.
8. malignant tumors.
9. Acute and/or chronic infectious diseases.
10. Severe cardiac arrhythmia found on electrocardiogram.
11. Mental illness, history of alcoholism, drug or other substance abuse.
12. Diagnosed with other connective tissue disease.
13. Those who have used immunosuppressants, biological agents, Colquhounia Root Tablet or drugs containing Tripterygium wilfordii within 1 month before enrollment.
14. Those who have previously used methotrexate or preparations containing tripterygium wilfordii for 12 weeks or more ,but their condition is not under control.
15. Adverse reactions have occurred in the past using Colquhounia Root Tablet or drugs containing Tripterygium wilfordii.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
45 Years
Maximum Age:
70 Years
Study:
NCT05393050
Study Brief:
Protocol Section:
NCT05393050