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Clinical Trials/TCTR20230116003
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

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Primary Sjogren&#039
Sponsor
Wei Liu
Enrollment
138
Status
Completed
Last Updated
last year

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
January 16, 2023
End Date
September 25, 2021
Last Updated
last year
Study Type
Interventional
Sex
All

Investigators

Sponsor
Wei Liu

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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