TCTR20230116003
Completed
Phase 1
Efficacy and Safety of acupuncture in the treatment of primary Sjogren's syndrome: a randomized controlled trial
Wei Liu0 sites138 target enrollmentJanuary 16, 2023
ConditionsPrimary Sjogren'
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Primary Sjogren'
- Sponsor
- Wei Liu
- Enrollment
- 138
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •(1\) Age greater than or equal to 18 and less than or equal to 75
- •(2\) Patient with a disease course of less than 10 years;
- •(3\) Patients without fundus lesions;
- •(4\) Hydroxychloroquine (HCQ) was taken before the test, the dosage was stable, and the treatment time was greater than or equal to 8 weeks;
- •(5\) EULAR Sjogren's syndrome patient reported index (ESSPRI) score greater than or equal to 4 points;
- •(6\) Salivary flow rate \> 0 mL/15min;
- •(7\) Schirmer test greater than or equal to 1 mm/5 min;
- •(8\) Patients agreed to join the study and signed the informed consent form.
Exclusion Criteria
- •(1\) Secondary Sjogren's syndrome or combined with other connective tissue diseases, such as systemic lupus erythematosus and rheumatoid arthritis;
- •(2\) Suffering from severe systemic diseases, such as pulmonary interstitial fibrosis and progressive renal damage, serious renal or liver dysfunction;
- •(3\) Patients with immunodeficiency syndrome;
- •(4\) Accompanied by severe heart, brain, liver, kidney, and other important organs or neuropathy;
- •(5\) Patients with mental illness or unconsciousness;
- •(6\) Patients with a history of alcohol or drug abuse;
- •(7\) Patients who received immunosuppressants, glucocorticoids, traditional Chinese medicine, and other treatments other than hydroxychloroquine sulfate within four weeks before enrollment;
- •(8\) Patients with contraindications to hydroxychloroquine sulfate;
- •(9\) Platelet count \< 50\*109;
- •(10\) Pregnant, lactating, or currently planned pregnant women;
Outcomes
Primary Outcomes
Not specified
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