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

NCT06519617 | Enrolling By Invitation Phase 2

• 1 other identifier: 2024-KY-173
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 1

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.

Conditions

Primary Sjögren Syndrome

Keywords

randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• VAS score

  12 weeks after treatment

• ESSPRI

  12 weeks after treatment

• Schirmer test

  12 weeks after treatment

Study Arms (2)

conventional program group

SHAM COMPARATOR

Hydroxychloroquine Sulfate Tablets 200-400mg daily for 12 weeks.

Drug: Hydroxychloroquine Sulfate

optimized program combining Chinese and Western medicine for pSS glandular damage

ACTIVE COMPARATOR

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

Interventions

Yi Qi Yang Yin Decoction DRUG

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.

Also known as: The treatment group

optimized program combining Chinese and Western medicine for pSS glandular damage

Hydroxychloroquine Sulfate DRUG

Hydroxychloroquine Sulfate Tablets 200-400mg daily for 12 weeks.

Also known as: the control group

conventional program group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. clinical diagnosis of pSS and qi and yin deficiency ; 2.Sign the informed consent form.

You may not qualify if:

• \. 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.

Sponsors & Collaborators

• Qingwen Tao: lead

Study Sites (1)

China-Japan friendship hospital

Beijing, Beijing Municipality, 100029, China

Location

MeSH Terms

Interventions

Hydroxychloroquine

Intervention Hierarchy (Ancestors)

Chloroquine; Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Qingwem Tao

  China-Japan Friendship Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: chief physician of rheumatism department of Chinese-medicine

Model Details: 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 injury.

Study Record Dates

• First Submitted: July 13, 2024
• First Posted: July 25, 2024
• Study Start: July 13, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 25, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)