Rheumatoid Arthritis
Conditions
Interventions
once weekly (administered on the day following methotrexate intake), for a 4-week medication course. (3) Ke luo Lei Feng Xiao Formulation, Usage: Oral administration, 100 ml per dose, twice daily, tak
Sponsors
Yunnan Provincial Hospital of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: Research participants must meet all of the following inclusion criteria to be enrolled in the trial: 1.Meet the Western medicine diagnostic criteria for RA. 2.Meet the Dai medicine diagnostic criteria for "Longmengshahou Feixiang" (Wind-Fire Excess Syndrome). 3.No gender restriction; age between 18 and 70 years old (inclusive of 18 and 70 years). 4.Participants have received =1 kind of conventional synthetic disease-modifying antirheumatic drug (csDMARD) other than methotrexate, with a stable drug dose for =3 months, and the dose will remain stable during the trial. 5.Participants have been informed and voluntarily agree to participate in this study, consent to sign the informed consent form for clinical research, and are willing to actively cooperate with the doctor's treatment, observation, and follow-up.
Exclusion criteria
Exclusion criteria: Research participants will be excluded from the trial if they meet any of the following criteria: 1.Do not meet the Western medicine diagnostic criteria for RA or the Dai medicine diagnostic criteria for "Longmengshahou Feixiang" (Wind-Fire Excess Syndrome). 2.Age is below 18 years or above 70 years. 3.Less than 3 months since miscarriage or pregnancy termination; currently pregnant, breastfeeding, or planning pregnancy. 4.Allergy or contraindication to any drug involved in the study. 5.DAS28-ESR score 1.5 times the upper limit of normal, BUN or Cr >1 times the upper limit of normal. 12.Use of biologics or JAK inhibitors within 30 days prior to enrollment. 13.Use of glucocorticoids prior to enrollment, with oral prednisone (or equivalent dose) >10mg and stable for less than 4 weeks before study entry, or discontinued for less than 1 week. 14.Use of non-steroidal anti-inflammatory drugs (NSAIDs) prior to enrollment, with low-dose use stable for less than 4 weeks, or discontinued for less than 1 week. 15.History of psychoactive substance or drug abuse and dependence. 16.Considered by the investigator to have poor compliance, inability to evaluate efficacy, or inability to complete the expected treatment course and follow-up. 17.Participation in any other drug or medical device clinical trial within 3 months prior to signing the informed consent form.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease Activity Score in 28 joints with Erythrocyte Sedimentation Rate(DAS28-ESR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Visual Analog Scale Score for Joint Pain(VAS) Score;Patient Global Assessment(PGA);Medical Doctor's Global Assessment(MDGA);Joint Function Grading Score;Health Assessment Questionnaire(HAQ);Chinese Rheumatoid Arthritis Patients' Self-Reported Disease Activity Index Scale(CPRI-RA);Dai Medicine Syndrome Score;Boolean Remission Criteria Fulfillment Status;Erythrocyte Sedimentation Rate(ESR);C-reactive protein(CRP); | — |
Countries
China
Contacts
Public ContactPeng jiangyun
Yunnan Provincial Hospital of Traditional Chinese Medicine
Outcome results
None listed