Rheumatoid arthritis
Conditions
Interventions
Treatment group:Methotrexate (MTX) tablets, 10mg/ time, once a week, taken orally at a fixed time every week
Folic acid tablets, 10mg/ time, once a week, taken orally for 24 hours after MTX
Qingre Tongbi Pills, 12 pills/time, twice a day, taken half an hour after breakfast and dinner.
Control group:Methotrexate (MTX) tablets, 10mg/ time, once a week, taken orally at a fixed time every week
Qingre Tongbi Pill Placebo, 12 pills/time, twice a day, taken half an hour after breakfast and dinner.
Sponsors
Affiliated Hospital of Gansu University of Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: (1) It conforms to the 2010 ACR/EULAR classification standard for rheumatoid arthritis, and is in the low and middle active stage of the disease (2.6=DAS28 score = 5.1); (2) It meets the diagnostic criteria of damp-heat stagnation syndrome in traditional Chinese medicine; (3) The patients are between 18 and 60 years old, regardless of sex; (4) Agree and sign the informed consent form.
Exclusion criteria
Exclusion criteria: (1) Patients with severe cardiovascular and cerebrovascular diseases, liver and renal insufficiency and mental illness; (2) Diagnosis of arthritis patients complicated with other connective tissue diseases; (3) Patients in pregnancy, lactation and pregnancy preparation; (4) Patients who were allergic to drugs such as methotrexate, etoricoxib and folic acid in the past; Or patients with severe allergies; (5) Patients with severe infection, active tuberculosis, hepatitis B and malignant tumor; (6) Patients who have been treated with traditional Chinese medicine such as oral administration of traditional Chinese medicine or external treatment of acupuncture in the past 2 weeks; Or patients who use glucocorticoids and anti-rheumatic drugs to improve their condition; Patients who have used biological agents before entering the group and are within the titer; (7) Patients who need to take painkillers in the past 2 weeks due to other chronic or recurrent pains except RA; (8) Patients who have participated in any interventional clinical research in the past 6 months; (9) Patients who cannot communicate effectively.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ACR20/50/70 response rate: the proportion of patients who reached ACR20/50/70 response in the 12th week.; | — |
Secondary
| Measure | Time frame |
|---|---|
| DAS28 change value: the absolute decline value of joint disease activity score (DAS28 score) from baseline at the 12th and 24th weeks (continuous variable).;Change value of morning stiffness time (minutes, continuous): the minute decline value of Zhou Chen stiffness time in the 12th week and 24th week.;VAS paresthesia score change value (0 ~ 10 cm): The VAS paresthesia score (0 ~ 10 cm) decreased in the 12th and 24th weeks.;VAS pain score change value (0 ~ 10 cm): the VAS pain score (0 ~ 10 cm) decreased in the 12th and 24th weeks.; | — |
Countries
China
Contacts
Public ContactXingwen Xie
Affiliated Hospital of Gansu University of Chinese Medicine
Outcome results
None listed