By InvitationPhase 2

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

China136 participantsStarted 2024-07-13

Plain-language 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.

Who can participate

Age range18 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

UWS score

Timeframe: 12 weeks after treatment

Trial details

NCT IDNCT06519617

SponsorQingwen Tao

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12-31

View on ClinicalTrials.gov More Primary Sjögren Syndrome trials