Sjögren's syndrome
Conditions
Interventions
treatment group:Qingzao Capsules, take 600mg each time, 3 times a day, dissolved in warm water
Control group:Placebo of Qingzao Capsules, taken 3 times a day, 600mg each time, dissolved in warm water
Sponsors
The First Teaching Hospital of Tianjin University of TCM
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: (1) Meet the diagnostic criteria of pSS in Western medicine; (2) Meet the diagnostic criteria for Yin deficiency and heat-toxicity syndrome in traditional Chinese medicine; (3) Age is greater than or equal to 18 and less than or equal to 70 years old; (4) ESSPRI (dryness/fatigue) is greater than or equal to 4; (5) During screening, if patients are currently using disease-modifying antirheumatic drugs, the treatment dose should be stable for at least 12 weeks. (6) During screening, if the patient is currently using glucocorticoids (prednisone or other equivalent hormones) for at least 12 weeks at a stable dose of less than or equal to 10mg/d, and this dose is not to be increased in subsequent treatment. (7) The subjects agree to participate in this study and sign the informed consent form.
Exclusion criteria
Exclusion criteria: (1) SS patients who are secondary to other rheumatic diseases, such as systemic lupus erythematosus and rheumatoid arthritis; (2) Those who have used biological agents and non-steroidal anti-inflammatory drugs in the past 12 weeks; (3) Patients who are currently in the process of preparing for pregnancy, are pregnant, or are breastfeeding; (4) Individuals who are allergic to the components of the test drug; (5) Patients with known ocular fundus lesions and heart block; (6) Patients with multiple tumors; (7) Patients with severe comorbidities involving the cardiovascular, cerebrovascular, pulmonary, hepatic, renal, and hematological systems; (8) Those who have participated or are currently participating in other intervention studies within the past 4 weeks; (9) Individuals with mental illnesses, intellectual disabilities, or other conditions that prevent them from accurately expressing their medical conditions or cooperating with the completion of the trial; (10) Positive results in hepatitis B surface antigen and hepatitis C antibody tests, positive HIV antibody, or a history of acquired immune deficiency syndrome (AIDS); (11) Individuals with a history of alcohol or drug abuse; (12) Individuals who, in the researcher's opinion, are not suitable to participate in this trial due to other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the EULAR Sjögren's syndrome patient reported index; | — |
Secondary
| Measure | Time frame |
|---|---|
| EULAR Sjögren's Syndrome Disease Activity Index;VAS score for dry eyes/dry mouth;Traditional Chinese Medicine syndrome score;Overall effective rate;Physician's Global Assessment;Patient's Global Assessment ;Functional Assessment of Chronic Illness Therapy-Fatigue;Schirmer test;static salivary flow rate;Laboratory indicators; | — |
Countries
China
Contacts
Public ContactLiu Wei
First Teaching Hospital of Tianjin University of TCM
Outcome results
None listed