Rheumatoid arthritis
Conditions
Interventions
Therapy group:Shuhe granula
Placebo group:Placebo
Sponsors
Guangdong Provincial Hospital of Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Subjects must meet all of the following conditions: (1) Aged 18-65 years; (2) Meet the RA classification standard of ACR 1987 or the RA classification standard of ACR/EULAR 2010; (3) Meet the 2016 ACR diagnostic criteria for fibromyalgia; (4) Pain visual analogue scale (VAS) score =2 points (20mm) within one week of enrollment; (5) Voluntary signing of informed consent.
Exclusion criteria
Exclusion criteria: Subject must exclude all of the following: (1) Severe chronic pain caused by other diseases, including diabetic pain, postherpetic neuralgia, etc.; (2) Combined with other severe rheumatic immune diseases, including systemic lupus erythematosus, systemic sclerosis, ankylosing spondylitis, myositis, vasculitis, etc.; (3) acute or chronic infectious diseases, including hepatitis B or C virus infection, mycobacterium tuberculosis infection, etc.; (4) complicated with serious cardiovascular, brain, lung, liver, kidney, hematopoietic system diseases; (5) Hemoglobin level less than 90 g/L, white blood cell count less than 3.0×10^9/L, or platelet count less than 100×10^9/L; (6) Patients with glomerular filtration rate less than 40ml/min; (7) aspartate aminotransferase or alanine aminotransferase was 1.5 times higher than the upper limit of the normal range; (8) neurological disorders that interfere with the assessment, such as paralysis, major sensory changes, and level of conscious understanding; (9) There are known mental illnesses such as severe cognitive impairment, major depression, and somatoform disorders; Patients who were evaluated as severe by the self-rating Depression tool (PHQ-9) or the Generalized Anxiety Scale (GAD-7); (10) Pregnant and lactating women; (11) Participating in other clinical trials within 4 weeks of screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Differences in Painvisualanaloguescale; | — |
Secondary
| Measure | Time frame |
|---|---|
| Morning stiffness time;TJC (tender joint count) 28;SJC (swollen joint count) 28;HAQ (health assessment questionnaire);RF (rheumatoid factor); CCP(anti-cyclic citrullinated peptide antibody);CRP(C-reactive protein);ESR (erythrocyte sedimentation rate);DAS28(Disease Activity Score 28);WPI(Widespread Pain Index);SSS(Symptom Severity Score);FIQR(Fibromyalgia Impact Questionnaire);FSS(Fatigue Severity Scale);ISI(Insomnia Severity Index Scale);PHQ-9(ThePatientHealthQuestionnaire);GAD-7(7-tiem Generalized Anxiety Disorder Scale); | — |
Countries
China
Contacts
Public ContactHuang Runyue
Guangdong Provincial Hospital of Chinese Medicine
Outcome results
None listed