drugset / Trial / NCT06519617

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

NCT06519617

Phase 2 Enrolling by invitation 136 enrolled Qingwen Tao
RandomizedParallel-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2024-07-13
Primary completion
2026-12-31
Completion
2026-12-31

Drugs

EvaluationDrugModalityDoseRoute
Comparator Hydroxychloroquine Small molecule 200 mg
Comparator Hydroxychloroquine Small molecule 400 mg
Comparator Yi Qi Yang Yin Decoction Traditional medicine (herbal / TCM) 200 ml

Indications