Study on Optimization and Evaluation of Integrated Chinese and Western Medicine for pSS Glandular Damage

Qingwen Tao

Status and phase

Invitation-only

Phase 2

Conditions

Primary Sjögren Syndrome

Treatments

Drug: Hydroxychloroquine Sulfate

Drug: Yi Qi Yang Yin Decoction

Study type

Interventional

Funder types

Other

Identifiers

NCT06519617

2024-KY-173

Details and patient eligibility

About

ChatGPT In a randomized controlled trial, 136 patients with primary Sjögren's syndrome (pSS) meeting the inclusion criteria were enrolled and randomly divided into two groups of 68 each. The treatment group received an optimized program combining Chinese and Western medicine for pSS glandular injury, while the control group received a conventional program for pSS glandular damage. The primary efficacy endpoint was the 12-week non-stimulated salivary flow rate (UWS) score. Secondary efficacy endpoints included the glandular damage Visual Analog Scale (VAS) scores, the European Sjögren's Syndrome Patient Reported Index (ESSPRI), among others. The treatment course lasted 12 weeks. The efficacy and safety of the optimized program for pSS glandular injury were evaluated by comparing within and between groups before and after treatment.

Enrollment

136 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

1. clinical diagnosis of pSS and qi and yin deficiency ; 2.Sign the informed consent form.

Exclusion criteria

1. pSS activity system damage (ESSDAI score ≥5); 2. Combined connective tissue diseases other than pSS; 3. Pregnant or lactating women; 4. severe cardiovascular and cerebrovascular diseases, liver and kidney failure, and severe malignant tumors; 5. taking psychotropic drugs; 6. assessed by the investigator to be ineligible for enrollment.