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EVADRY® in the Treatment of Xerostomia in Sjögren's Syndrome

NCT06313905 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2024-03-15

No results posted yet for this study

Summary

Xerostomia is a common and very bothersome manifestation that impairs the quality of life in Sjogren's syndrome. Symptomatic therapeutic alternatives for this syndrome are limited in Tunisia. We resort to bromhexine off-label with low efficacy. The aim of this work is to demonstrate the superiority of a treatment based on dietary supplements (EVADRY) vs placebo in the treatment of xerostomia. This is a double-blind randomized clinical trial with 2 arms: an EVADRY arm (n=90) and a placebo arm (n=90). The primary outcome measure is a 35% increase in salivary flow after 3 months. Secondary outcome measures were based on the Oral Health Impact Profile questionnaire, Xerostomia Inventory, the HAD depression scale, and the buccal Schirmer test.

Conditions

  • Sjogren's Syndrome

Interventions

DIETARY_SUPPLEMENT

EVADRY

The EVADRY oral spray and the placebo are produced by Wellnet laboratory. • EVADRY spray: It is a phytotherapy-based medication in the form of an oral spray. It is a 100 ml bottle containing ALEO BARBADENSIS LEAF WATER (1 ml), Chamomilla Recutita Flower extract (30 mg), TOCOPHEROL (10 mg), hyaluronic acid (2 mg), mentha spicata herb oil (10 mg), and eugenol (40 µg).

OTHER

Placebo

The placebo corresponds to flavored water (mint extract) with the same taste as EVADRY. It is placed in a bottle with the same appearance as EVADRY. Both products are administered at a rate of 5 intra-oral sprays per day.

Sponsors & Collaborators

  • University Tunis El Manar

    lead OTHER

Principal Investigators

  • Ines Naceur · Centre Hospitalo-Universitaire La Rabta

  • Tayssir Ben Achour · Centre Hospitalo-Universitaire La Rabta

  • Mayssam Jridi · Centre Hospitalo-Universitaire La Rabta

  • Monia Smiti · Centre Hospitalo-Universitaire La Rabta

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-15
Primary Completion
2024-12-31
Completion
2025-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06313905 on ClinicalTrials.gov