primary sjogren's syndrome
Conditions
Interventions
Test group:Modified Yiguanjian, one sack/time,bid + hydroxychloroquine 5~6mg/kg/d
Control group:Hydroxychloroquine 5~6mg/kg/d
Sponsors
The First Affiliated Hospital, Army Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) Age 18-75 years old; 2) Meet the 2002 AECG or 2016 ACR/EUALR classification criteria of Sjögren's syndrome and the diagnostic criteria of yin deficiency and blood dryness syndrome in traditional Chinese medicine; 3) The patient agrees and signs the informed consent, and can implement the treatment plan and follow-up as required.
Exclusion criteria
Exclusion criteria: 1) Patients with secondary SS; 2) Patients with severe systemic organ damage secondary to Sjögren's syndrome, such as severe thrombocytopenia, lymphoma, renal tubular acidosis, nephrogenic diabetes insipidus, neuromyelitis optica, interstitial lung disease or recent uncured lung infections; 3) Combined with serious diseases such as severe diabetes, severe hypertension, cardiovascular and cerebrovascular diseases, history of previous hematologic diseases, etc.; 4) Those who have contraindications to hydroxychloroquine treatment or are allergic to or cannot tolerate the drugs in this prescription; 5) Patients with comorbid glaucoma, fundus disease, ocular trauma or other active ocular surface disease; 6) Inability to adhere to the implementation of treatment and follow-up according to the requirements of the trial; 7) Presence of other serious diseases in the body or oral administration of drugs that may affect the results of the test; 8) Pregnant or lactating women, or those who have recent reproductive needs; 9) Those with mental illness and intellectual and speech disabilities; 10) Those who are participating in clinical trials of other drugs, or have completed clinical trials of other drugs for less than 3 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| general score for disease activity;TCM syndrome score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Sjögren's Tool for Assessing Response;Laboratory indicators(IgA, IgG, IgM, C3, C4, SSA, SSB, RF, et al);first part of score for xerostomia and xerophthalmia;second part of score for xerostomia and xerophthalmia; | — |
Countries
China
Contacts
Public Contactzhong bing
The First Affiliated Hospital, Army Medical University
Outcome results
None listed