Efficacy and Safety of acupuncture in the treatment of primary Sjogren's syndrome: a randomized controlled trial

Phase 1

Completed

• Conditions: Primary Sjogren&#039

• Registration Number: TCTR20230116003
• Lead Sponsor: Wei Liu

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2021-09-25
• Study Start: 2023-01-16
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 138

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;
(11) Participating in other clinical trials within three months before the trial or currently;
(12) Patients with contraindications to acupuncture (metal allergy and skin damage at relevant acupoints).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ESSPRI score 8 weeks The ESSPRI score of participants

Secondary Outcome Measures

Name	Time	Method
The numerical rating score (NRS) of dry eyes 8 weeks The NRS score of dry eyes