Status:
UNKNOWN
Efficacy and Safety of Colquhounia Root Tablet in Patients With Rheumatoid Arthritis
Lead Sponsor:
Quan Jiang
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
45-70 years
Phase:
PHASE4
Brief Summary
This study is a multi-center, randomized, double-blinded, controlled trial with two parallel arms. The aim of the study is to evaluate whether Colquhounia Root Tablet combined with methotrexate (MTX) ...
Eligibility Criteria
Inclusion
- Subject understood the whole process of the trial and signed the informed consent voluntarily.
- Subject has had a confirmed diagnosis of rheumatoid arthritis according to 2010 ACR/EULAR RA classification criteria.
- Subjects aged between 45-70years who were the males without fertility requirements or menopausal women.
- Subject has a DAS28 CRP disease activity score greater than 2.6 and less than 5.1.
- Subject did not participate in any drug trials within 1 month before enrollment.
Exclusion
- Pregnant women, women planning to become pregnant or breastfeeding.
- Severe systemic involvement, such as severe pericardial effusion, interstitial lung disease, renal tubular acidosis, autoimmune liver disease.
- Active liver disease or abnormal liver function, ALT and AST are more than 1.5 times the upper limit of normal.
- Renal impairment, serum creatinine greater than the upper limit of normal.
- 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.
- Active gastric and duodenal ulcers.
- Uncontrolled severe hypertension, metabolic diseases.
- malignant tumors.
- Acute and/or chronic infectious diseases.
- Severe cardiac arrhythmia found on electrocardiogram.
- Mental illness, history of alcoholism, drug or other substance abuse.
- Diagnosed with other connective tissue disease.
- Those who have used immunosuppressants, biological agents, Colquhounia Root Tablet or drugs containing Tripterygium wilfordii within 1 month before enrollment.
- Those who have previously used methotrexate or preparations containing tripterygium wilfordii for 12 weeks or more ,but their condition is not under control.
- Adverse reactions have occurred in the past using Colquhounia Root Tablet or drugs containing Tripterygium wilfordii.
Key Trial Info
Start Date :
July 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2024
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT05393050
Start Date
July 1 2022
End Date
June 1 2024
Last Update
July 8 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Beijing, Beijing Municipality, China, 100052