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

Phase 2

• Conditions: Primary Sjögren Syndrome
• Interventions: Drug: Yi Qi Yang Yin Decoction; Drug: Hydroxychloroquine Sulfate

• Registration Number: NCT06519617
• Lead Sponsor: Qingwen Tao

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-07
• Study Start: 2024-07-13
• Study First Submitted: 2024-07-13
• Study First Submitted QC: 2024-07-19
• Last Update Submitted: 2024-07-19
• Study First Posted: 2024-07-25
• Last Update Posted: 2024-07-25
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 136

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
optimized program combining Chinese and Western medicine for pSS glandular damage	Yi Qi Yang Yin Decoction	The herbal prescription for patients eligible for qi and yin deficiency was 200 ml twice daily for 12 weeks.
conventional program group	Hydroxychloroquine Sulfate	Hydroxychloroquine Sulfate Tablets 200-400mg daily for 12 weeks.

Primary Outcome Measures

Name	Time	Method
UWS score	12 weeks after treatment	unstimulated flow rate of saliva score. it is positive if the UWS ≤1.5 ml/15 min（or 0.1 ml/min). Higher scores(ml/min) mean a better outcome.

Secondary Outcome Measures

Name	Time	Method
VAS score	12 weeks after treatment	the glandular damage Visual Analog Scale score(dryness, fatigue and pain in the limbs). Patient self-assessed VAS scores ranged from 0 to 10. Higher scores mean a worse outcome.
ESSPRI	12 weeks after treatment	the European Sjögren's Syndrome Patient Reported Index, average of dryness, fatigue and pain in the limbs VAS scores. ESSPRI score varies from 0 to 10. Higher scores mean a worse outcome.
Schirmer test	12 weeks after treatment	Lacrimal secretion test. it is positive if the UWS ≤5 mm/5 min（or 1 mm/min). Higher scores(mm/min) mean a better outcome.

Trial Locations

Locations (1)

China-Japan friendship hospital; 🇨🇳 Beijing, Beijing, China