Status:
COMPLETED
Effects of Acupuncture on Sjögren's Syndrome
Lead Sponsor:
Ana Carolina Fragoso Motta, DDS, PhD
Conditions:
Sjogren's Syndrome
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 sym...
Detailed Description
The present study is designed as a 24-month, single centre, double-blind, randomized, controlled, two-arm clinical trial (acupuncture and control). The research will be conducted following the CONSORT...
Eligibility Criteria
Inclusion
- Adults ≥ 18 years old, both genres, who consent to participate of the study
- Patients who were diagnosed with SJ according to the criteria of the American College of Rheumatology and the European League against Rheumatism
Exclusion
- Patients who have undergone head and neck radiation therapy;
- Patients with a history of neoplasias and salivary gland infections;
- Patients with acquired immunodeficiency virus infection, sarcoidosis, viral hepatitis, diabetes mellitus and smokers;
- Patients with inability to undergo total saliva collection by established techniques;
- Patients who can not attend regular acupuncture sessions;
- Patients who had a change in the dosage of medications in use within 6 weeks before the start of the study.
- Patients who received acupuncture therapy up to 6 weeks prior to the start of the study.
Key Trial Info
Start Date :
February 18 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 10 2022
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04056221
Start Date
February 18 2019
End Date
October 10 2022
Last Update
March 14 2023
Active Locations (1)
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1
School of Dentistry of Ribeirão Preto, University of São Paulo
Ribeirão Preto, São Paulo, Brazil, 14040-904