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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

PHASE2

Total Enrollment

136 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-13

Study Completion Date

2026-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Primary Sjögren Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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conventional program group

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

Group Type SHAM_COMPARATOR

Hydroxychloroquine Sulfate

Intervention Type DRUG

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

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.

Group Type ACTIVE_COMPARATOR

Yi Qi Yang Yin Decoction

Intervention Type 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.

Interventions

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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.

Intervention Type DRUG

Hydroxychloroquine Sulfate

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

Intervention Type DRUG

Other Intervention Names

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The treatment group the control group

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No