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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Primary Sjögren Syndrome
• Intervention / Treatment: Drug: Hydroxychloroquine Sulfate; Drug: Yi Qi Yang Yin Decoction

• Study Type: Interventional
• Enrollment (Estimated): 136
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100029
      • China-Japan Friendship Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: conventional program group; Hydroxychloroquine Sulfate Tablets 200-400mg daily for 12 weeks.	Drug: Hydroxychloroquine Sulfate; Hydroxychloroquine Sulfate Tablets 200-400mg daily for 12 weeks.; Other Names: the control group
Active Comparator: optimized program combining Chinese and Western medicine for pSS glandular damage; The herbal prescription for patients eligible for qi and yin deficiency was 200 ml twice daily for 12 weeks.	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.; Other Names: The treatment group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
UWS score	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.	12 weeks after treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
VAS score	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.	12 weeks after treatment
ESSPRI	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.	12 weeks after treatment
Schirmer test	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.	12 weeks after treatment

Collaborators and Investigators

• Sponsor: Qingwen Tao
• Investigators: Study Chair: Qingwem Tao, China-Japan Friendship Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 13, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: July 13, 2024
• First Submitted That Met QC Criteria: July 19, 2024
• First Posted (Actual): July 25, 2024

Study Record Updates

• Last Update Posted (Actual): July 25, 2024
• Last Update Submitted That Met QC Criteria: July 19, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: randomized controlled trial
• Additional Relevant MeSH Terms: Pathologic Processes; Immune System Diseases; Autoimmune Diseases; Eye Diseases; Disease; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Stomatognathic Diseases; Mouth Diseases; Lacrimal Apparatus Diseases; Arthritis, Rheumatoid; Xerostomia; Salivary Gland Diseases; Dry Eye Syndromes; Syndrome; Sjogren's Syndrome; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antirheumatic Agents; Antiprotozoal Agents; Antiparasitic Agents; Antimalarials; Hydroxychloroquine
• Other Study ID Numbers: 2024-KY-173

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No