Rheumatoid Arthritis
Conditions
Interventions
Treatment Group:(1)Methotrexate Tablets, Usage: Oral administration, 10 mg per dose, taken 30 minutes after lunch
once weekly (administered on the day following methotrexate intake), for a 4-week medication course. (3) Sise Xuanmiao Decoction, Usage: Oral administration, 100 ml per dose, three times daily, taken
Control Group: (1)Methotrexate Tablets, Usage: Oral administration, 10 mg per dose, taken 30 minutes after lunch
Sponsors
Yunnan Provincial Hospital of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: To be eligible for inclusion in the study, research participants must meet all of the following criteria: (1) Meet the Western medical diagnostic criteria for rheumatoid arthritis (RA). (2) Meet the Yi medical diagnostic criteria for Wind-Heat-Toxin Pattern (Damp-Heat Obstruction Pattern). (3) No gender restrictions; age must be between 18 and 70 years of age (inclusive of 18 and 70 years old). (4) Prior to enrollment, have received =1 type of disease-modifying antirheumatic drug (csDMARDs) other than methotrexate, with a stable drug dosage for =3 months, and maintain stable dosage during the study period. (5) The participant must be fully informed and voluntarily agree to participate in this clinical study, consent to sign the informed consent form for entering the clinical study, and be able to actively cooperate with medical treatment, observation, and follow-up.
Exclusion criteria
Exclusion criteria: Participants who meet any of the following criteria are not eligible for inclusion in the trial: (1) Those who do not meet the diagnostic criteria for RA in Western medicine or Yi medicine (wind-heat-toxicity syndrome or damp-heat obstruction syndrome). (2) Individuals under 18 years of age or over 70 years of age. (3) Those who have experienced a miscarriage or termination of pregnancy within the past 3 months, or are currently pregnant, breastfeeding, or planning to conceive. (4) Individuals with allergies to the drugs involved in the study or contraindications for their use. (5) DAS28-ESR scores 1.5 times the upper limit of normal, BUN or Cr >1 times the upper limit of normal. (12) Individuals who have used biologics or JAK inhibitors within the past 30 days. (13) Participants who have received glucocorticoid therapy, with prednisone (or equivalent) oral dosage >10mg prior to entering the study, and stabilization for less than 4 weeks, or discontinuation within <1 week. (14) Participants who have received nonsteroidal anti-inflammatory drug (NSAID) therapy, with low-dose stable use for <4 weeks, or discontinuation within <1 week. (15) Individuals with substance abuse, drug dependence, or addiction. (16) Participants deemed by the investigator to have poor compliance, making it difficult to assess efficacy or complete the expected course of treatment and follow-up. (17) Individuals who have participated in other drug or medical device clinical trials within the past 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 |
|---|---|
| Joint Pain Visual Analog Scale Score;Patient's global rating of their own disease activity;Overall assessment of disease activity by the physician;Joint Function Grading Score;Health Assessment Questionnaire Scoring;Chinese Rheumatoid Arthritis Patients' Self-Reported Disease Activity Index Scale(CPRI-RA);Yi Medicine Syndrome Scoring;Boolean Mitigation Criteria Status;Erythrocyte Sedimentation Rate;C-reactive protein; | — |
Countries
China
Contacts
Public ContactPeng jiangyun
Yunnan Provincial Hospital of Traditional Chinese Medicine
Outcome results
None listed