NCT06519617

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

Study on Optimization and Evaluation of Integrated Chinese and Western Medicine for Primary Sjogren's Syndrome Glandular Damage

• Status: Enrolling By Invitation
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 136 (estimated)
• Sponsor: Qingwen Tao · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Primary Sjögren Syndrome

Interventions

Type	Name	Description
DRUG	Yi Qi Yang Yin Decoction	The Yi Qi Yang Yin Decoction (Dihuang 15g, Baihe 12g, Nanshashen 15g, celery Qinghao 10g, Malt 10g, Shengma 6g, Chaihu 6g) prescription for patients eligible for qi and yin deficiency was 200 ml twice daily for 12 weeks.
DRUG	Hydroxychloroquine Sulfate	Hydroxychloroquine Sulfate Tablets 200-400mg daily for 12 weeks.

Timeline

• Start date: 2024-07-13
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2024-07-25
• Last updated: 2024-07-25

Locations

1 site across 1 country: China