Active rheumatoid arthritis
Conditions
Interventions
Experimental drug set:Search wind Sanjie particles boiled water 1 bag 2 times a day
Non-rheumatoid arthritis:No medical intervention
Placebo group:Soufeng Sanjie granule simulator take with boiling water 1 bag at a time 2 times a day
Rheumatoid arthritis (non-phlegm-stasis obstruction syndrome) patients:No medical intervention
Sponsors
Suzhou Hospital of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1 Rheumatoid arthritis (Phlegm-stasis obstruction syndrome) (1) Comply with ACR/EULAR (2010) classification standards; (2) Conforming to the standard of TCM phlegm-stasis bi syndrome differentiation; DAS28 (ESR) >3.2 or DAS28 (CRP) >3.2; (4) Age 18-65 years old (including both ends) gender is not limited; (5) have not used NSAIDs drugs for at least 1 week; Or if used the dose has been stable for at least 4 weeks; (6) had been treated with methotrexate (MTX) for at least 12 weeks and kept the dose stable (7.5-20 mg/ week) for 4 weeks; (7) At least 1 week has not used medium-acting short-acting hormones or 2 weeks has not used long-acting hormones; Or if you have received prednisone (=10mg/ day) or equivalent hormone therapy the dose should be stable for at least 30 days before entering the study and maintained during subsequent therapy; (8) Informed consent and sign informed consent. 2 Rheumatoid arthritis (non-phlegm-stasis syndrome) (1) Comply with ACR/EULAR (2010) classification standards; DAS28 (ESR) >3.2 or DAS28 (CRP) >3.2; (3) Age 18-65 years old (including both ends) gender is not limited; (4) have not used NSAIDs drugs for at least 1 week; Or if used the dose has been stable for at least 4 weeks; (5) had been treated with methotrexate (MTX) for at least 12 weeks and kept the dose stable (7.5-20 mg/ week) for 4 weeks; (6) At least 1 week has not used a medium or short-acting hormone or 2 weeks has not used a long-acting hormone; Or if you have received prednisone (=10mg/ day) or equivalent hormone therapy the dose should be stable for at least 30 days before entering the study and maintained during subsequent therapy; (7) Informed consent and sign informed consent. 3 Non-rheumatoid arthritis (1) Age 18-65 years old (including both ends) gender is not limited; (2) does not meet the ACR/EULAR (2010) classification standards; (3) I voluntarily participate in the experiment and sign the informed consent.
Exclusion criteria
Exclusion criteria: 1 Rheumatoid arthritis (Phlegm-stasis obstruction syndrome) (1) Patients with other inflammatory joint diseases or autoimmune diseases such as knee osteoarthritis gouty arthritis psoriatic arthritis reactive arthritis and other connective tissue diseases caused by arthritis systemic lupus erythematosus Sjogren's syndrome myositis or dermatomyositis; (2) Patients with a history of blood system diseases; (3) Patients with other malignant tumors cardiovascular cerebrovascular liver kidney endocrine system and other serious diseases; (4) Patients with diarrhea diabetes ulcerative colitis Crohn's disease or other infectious diseases; (5) Use of anti-rheumatic drugs or biologic agents other than methotrexate (MTX) to improve the condition: use salazopyridine hydroxychloroquine penicillamine cyclosporin azathioprine cyclophosphamide eramodine etc. within 4 weeks or not more than 5 half-lives; Use of herbal preparations (including tripterygium wilfordis preparations total glucosides of paeony sinomenine and other proprietary Chinese medicines and/or Chinese herbal medicines etc.) within 4 weeks; Use flunomide within 8 weeks; The use of biologics did not exceed 5 half-lives such as anabaricin or etanercept within 4 weeks infliximab within 8 weeks Golimumab or cetuzumab or tolumab within 10 weeks abacil within 12 weeks Dinosemide within 21 weeks etc. (6) Patients who have taken antibiotics or microecological regulators containing probiotics within 3 months; (7) Patients who have received chemotherapy radiotherapy or surgery within 3 months; (8) Those with irregular eating habits in the week before screening; (9) Patients with joint function grade IV; (10) X-ray stage IV; (11) SCr exceeds the upper limit of normal value or any item of ALT or AST exceeds 1.5 times the upper limit of normal value; (12) Blood routine white blood cells < 3.0×109/L or platelets < 90×109/L; (13) Women who plan to become pregnant during pregnancy or within half a year breastfeeding women; (14) Persons with mental illness or cognitive disabilities; (15) Allergic to or allergic to the known ingredients of the investigational drug; (16) Suspected or confirmed to have a history of alcohol addiction or drug abuse; (17) Attended other clinical investigators within 30 days prior to screening; (18) The investigator considers it inappropriate to participate in this clinical study. 2 Rheumatoid arthritis (non-phlegm-stasis syndrome) (1) Conforming to the standard of TCM phlegm-stasis bi syndrome differentiation; (2) Patients with other inflammatory joint diseases or autoimmune diseases such as knee osteoarthritis gouty arthritis psoriatic arthritis reactive arthritis and other connective tissue diseases caused by arthritis systemic lupus erythematosus Sjogren's syndrome myositis or dermatomyositis; (3) Patients with a history of blood system diseases; (4) Patients with other malignant tumors cardiovascular cerebrovascular liver kidney endocrine system and other serious diseases; (5) Patients with diarrhea diabetes ulcerative colitis Crohn's disease or other infectious diseases; (6) Use of anti-rheumatic drugs or biologic agents other than methotrexate (MTX) to improve the condition: use salazopyridine hydroxychloroquine penicillamine cyclosporin azathioprine cyclophosphamide eramodine etc. within 4 weeks or not more than 5 half-lives; Use of herbal preparations (including tripterygium wilfordis preparations total glucosides of paeony sinomenine and other p
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of study participants with ACR 20 ACR 50 and ACR 70; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in X-ray staging from baseline;TCM syndrome effect;;Single symptom or sign disappeared after medication;Changes in ESR CRP RF and anti-CCP antibodies from baseline;Proportion of study participants with DAS28 (CRP) =2.6 DAS28 (ESR) =2.6 DAS28 (CRP) > 2.6 and =3.2 DAS28 (ESR) > 2.6 and =3.2;Changes in pain VAS scores of study participants from baseline;Changes in joint function grade from baseline;Percentage of study participants with ACR 20 ACR 50 and ACR 70;Changes in study participants' HAQ-DI scores from baseline; | — |
Countries
China
Contacts
Public Contacthaodonglin
Suzhou Hospital of Traditional Chinese Medicine
Outcome results
None listed