primary Sjogren's syndrome
Conditions
Interventions
Control group:Chinese medicine prescriptions
Experimental group:IGU combined with traditional Chinese medicine prescriptions
Sponsors
Guang'anmen Hospital, Chinese Academy of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) The patient agrees to join the study and signs an informed consent form; 2) Age range from 18 to 75 years old, regardless of gender; 3) Diagnosed as primary Sjogren's syndrome, in accordance with the ACR-EULAR 2016 International Classification of Primary Sjogren's Syndrome; 3) Diagnosed as primary Sjogren's syndrome, referring to ACR-EULAR 2016 International Primary Sjogren's Syndrome 4)Classification criteria for conformity; Main symptoms: ? Dry mouth and eyes; ? fatigue of spirit Secondary symptoms: ? palpitations due to movement; ? Short of breath and lazy speech; ? Dry cough with less phlegm and dry throat; ? Night urination frequency; ? Loose stools. Tongue pulse: The tongue is red, with few dry or cracked fur, and the pulse is thin or thin. 5) Having two main symptoms; Or one main symptom and two secondary symptoms can be diagnosed by combining tongue and pulse. 6) Have not received pSS treatment or have a stable pSS drug treatment regimen for more than 3 months; 7) Sjögren syndrome or Sjögren syndrome; 8) Moderate disease activity is defined as an ESSDAI score of 5-13.
Exclusion criteria
Exclusion criteria: 1) Have a history of Hypersensitivity or intolerance to any of the research treatment drugs; 2) Previously received treatment with Eramod; 3) He has received the treatment of Paeonia lactiflora, Tripterygium wilfordii or other traditional Chinese patent medicines and simple preparations within 2 weeks before joining the group; 4) He received Cyclophosphamide treatment within 1 month before enrollment; 5) Within 6 months prior to enrollment, received Flumiphene treatment; 6) Received Rituximab within 6 months before enrollment, or received Rituximab 3 months before enrollment Other biological agents (such as tofatib) for treatment other than; 7) Other autoimmune diseases with definite diagnosis, such as Rheumatoid arthritis and systemic redness Lupus erythematosus, etc; 8) Existence of acute and/or chronic infectious diseases, such as HBsAg positive, anti HCV positive, anti-HIV positive, etc; 9) Serious infection or Opportunistic infection, and the infection has not been controlled; 10) Active gastrointestinal diseases, such as gastric ulcers, duodenal ulcers, etc; 11) Abnormal blood or organ function: Liver function: Any one of the indicators in ALT, AST, and TBIL exceeds 1.5 times the upper limit of normal value (ULN); Renal function: blood creatinine exceeds 1.5 times the upper limit of normal value (ULN); Bone marrow function: White blood cells<3.0 × 10 9/L, or hemoglobin<80g/L, or platelets<80 × 10 9/L; 12) Those who have received the vaccine within 3 months before enrollment or plan to receive it during the research and treatment period; 13) Having malignant tumors within 3 years prior to enrollment; 14) Pregnant, lactating, or planned pregnant women, or women of childbearing age who are unwilling to take reliable contraceptive measures during the study period; 15) Those who are receiving any other experimental drugs or experimental medical devices; 16) Researchers believe that patients may have accompanying diseases (such as neurological or psychiatric disorders) or any other conditions that seriously endanger patient safety, may confuse research results, or affect the completion of this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ESSADAI (EULAR Sjogren's Syndrome Disease Activity Index); | — |
Secondary
| Measure | Time frame |
|---|---|
| ESSPRI;Schirmer;SGUS;Quality of life score; | — |
Countries
China
Contacts
Public ContactXiaopo Tang
Guang'anmen Hospital, Chinese Academy of Traditional Chinese Medicine
Outcome results
None listed