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

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

TCTR

Registry ID

TCTR20230116003

Enrollment

138

Registered

2023-01-16

Start date

2018-09-25

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Sjogren&#039

Interventions

Acupuncture points included Baihui (DU20), Lianquan (RN23), Jinjin, Yuye (EX-HN12), Jiache (ST6) (bilateral), Cuanzhu (BL2) (bilateral), Taiyang (EX-HN5) (bilateral), Sibai (ST2) (bilateral), Jingming

Experimental Other

acupuncture

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion 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

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).

Design outcomes

Primary

Measure	Time frame
ESSPRI score 8 weeks The ESSPRI score of participants	—

Secondary

Measure	Time frame
The numerical rating score (NRS) of dry eyes 8 weeks The NRS score of dry eyes	—

Countries

China

Contacts

Public ContactWei Liu

First Teaching Hospital of Tianjin University of Traditional Chinese Medicine

fengshiliuwei@163.com18880370759

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026

Efficacy and Safety of acupuncture in the treatment of primary Sjogren&#039;s syndrome: a randomized controlled trial