Sjögren's syndrome
Conditions
Interventions
Treatment group:Shaoteng granule+ Hydroxychloroquine sulfate tablets placebo
Control group:Hydroxychloroquine sulfate tablets+ Shaoteng granule placebo
Sponsors
Guang’anmen Hospital,China Academy of Chinese Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Those who meet all of the following criteria are eligible for inclusion: ? pSS patients who meet the diagnostic criteria of Western medicine; ? pSS patients who meet the criteria of TCM Qi and Yin deficiency and blood stasis blocking collaterals; ? Age 18-65 years old; ? Stop using other antirheumatic drugs, such as glucocorticoids and immunosuppressants, for at least one month. If the pain is severe, NSaids can be taken temporarily, but the name, dosage and method of use should be recorded in detail. ? The patient agrees to receive treatment and examination for 6 months, and signs the informed consent.
Exclusion criteria
Exclusion criteria: Exclusions shall be made if any of the following conditions are met: ? Patients with secondary sjogren syndrome; ? Serious heart, liver, kidney, brain and other important organ lesions not caused by this disease; ? Patients who had received immunosuppressants, chloroquine, and adrenal corticosteroids 4 weeks before the trial; ? Patients with concomitant neurological damage, glomerular acidosis, interstitial pneumonia, liver damage, serious damage (such as severe hypokalemia); ? Pregnant or nursing women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| General item;Vital sign;VAS score;Laboratory examination;ESSDAI score;ESSPRI score;Safety evaluation; | — |
Countries
China
Contacts
Public ContactXiaopo Tang
Guang’anmen Hospital,China Academy of Chinese Medical Sciences
Outcome results
None listed