NCT04056221

Effects of Acupuncture on Sjögren's Syndrome

Completed NA Last updated 14 March 2023

What this trial tests

NA trial testing Acupuncture in Sjogren's Syndrome in 50 participants. Completed in 10 October 2022.

Timeline

18 February 2019

Primary endpoint
6 December 2021

10 October 2022

Quick facts

Lead sponsor	Ana Carolina Fragoso Motta, DDS, PhD
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	50
Start date	18 February 2019
Primary completion	6 December 2021
Estimated completion	10 October 2022
Sites	1 location across Brazil

Drugs / interventions tested

• Acupuncture — full drug profile →
• Sham acupuncture

Conditions studied

• Sjogren's Syndrome — all drugs for Sjogren's Syndrome →

Sponsor

Ana Carolina Fragoso Motta, DDS, PhD

Who can join

18 and older, any sex, with Sjogren's Syndrome. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Sjögren's syndrome (SS) is a multisystemic chronic autoimmune disease characterized by lymphocytic infiltration of the exocrine glands, resulting in salivary and lacrimal glands hypofunction, with symptoms of dry eyes and mouth. Xerostomia and xerophthalmia present profound negative impact on patients' quality of life, especially due to difficulties in swallowing, dysarthria, dysgeusia, halitosis and burning tongue, discomfort and visual disturbances that lead to daily activities difficulty such as driving or reading. Although some drugs may improve symptoms and prevent SS complications, they can cause significant adverse effects and even fail to relieve symptoms. Integrative and complementary techniques have become a therapeutic option for SS patients. Scientific evidence has supported the efficacy of acupuncture in relieving symptoms of xerostomia and xerophthalmia. Due to the lack of well-controlled and standardized clinical studies, this study aimed to conduct a randomized and controlled trial to determine the efficacy of acupuncture as a therapeutic option for SS patients' symptoms relief.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Dry eye syndrome: comprehensive etiologies and recent clinical trials.
   Huang R, Su C, Fang L, Lu J, et al · · 2022 · cited 52× · PMID 35678897 · DOI 10.1007/s10792-022-02320-7
2. Understanding Fatigue in Sjögren's Syndrome: Outcome Measures, Biomarkers and Possible Interventions.
   Mæland E, Miyamoto ST, Hammenfors D, Valim V, et al · · 2021 · cited 25× · PMID 34249008 · DOI 10.3389/fimmu.2021.703079
3. Prospective Sham-Controlled trial: acupuncture for symptom-relieving in patients with Sjögren's disease.
   Gomes-Silva JM, Torres CP, Teixeira LR, Saraiva MDCP, et al · · 2025 · PMID 40178679 · DOI 10.1007/s10067-025-07410-2