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ENROLLING BY INVITATION
NCT06519617
PHASE2

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

Sponsor: Qingwen Tao

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

136

Start Date

2024-07-13

Completion Date

2026-12-31

Last Updated

2024-07-25

Healthy Volunteers

No

Interventions

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.

Locations (1)

China-Japan friendship hospital

Beijing, Beijing Municipality, China