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

NCT06313905 | Not Yet Recruiting DMC

• 2 other identifiers: DRYLESS1CHU La Rabta
• Study Type: interventional
• Target: 180
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

xerostomia; sjogren's syndrom; treatment

Outcome Measures

Primary Outcomes (1)

• salivary flow rate (SFR)

  It consists of asking the patient to collect their saliva in the morning without prior stimulation (no smoking, chewing gum, or alcohol one hour before) in a graduated tube for 15 minutes. The patient should be comfortably seated with their head slightly tilted forward and their mouth open to allow saliva to flow. A value less than 0.1 ml/minute corresponds to hyposalivation.

  at inclusion, after 1, 2 and 3 months

Secondary Outcomes (4)

• Xerostomia Inventory in French version

  at inclusion, after 1, 2 and 3 months

• Oral Health-related quality of life (OHIP-14) questionnaire

  at inclusion, after 1, 2 and 3 months

• Hospital anxiety and depression (HAD) scale

  at inclusion, after 1, 2 and 3 months

• Buccal Schirmer test

  at inclusion, after 1, 2 and 3 months

Study Arms (2)

EVADRY

EXPERIMENTAL

90 Sjogren's syndrom patients with objective xerostomia receiving the EVADRY dietary supplement treatment.

Dietary Supplement: EVADRY

PLACEBO

PLACEBO COMPARATOR

90 Sjogren's syndrom patients with objective xerostomia receiving a placebo.

Other: Placebo

Interventions

EVADRY DIETARY_SUPPLEMENT

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).

EVADRY

Placebo OTHER

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.

PLACEBO

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age over 18 years
• diagnosis of Sjogren's syndrome according to ACR/EULAR 2016 criteria
• continuous xerostomia for more than 3 months
• initial salivary flow rate \< 0.1 ml/min

You may not qualify if:

• Occurrence of cognitive or dementia disorders
• Pregnancy
• Allergy to any of the components of the EVADRY product
• Indication of oral or throat surgery

Sponsors & Collaborators

• University Tunis El Manar: lead

MeSH Terms

Conditions

Sjogren's Syndrome; Xerostomia

Condition Hierarchy (Ancestors)

Arthritis, Rheumatoid; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Dry Eye Syndromes; Lacrimal Apparatus Diseases; Eye Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Ines Naceur

  Centre Hospitalo-Universitaire La Rabta

  STUDY CHAIR

• Tayssir Ben Achour

  Centre Hospitalo-Universitaire La Rabta

  STUDY CHAIR

• Mayssam Jridi

  Centre Hospitalo-Universitaire La Rabta

  STUDY CHAIR

• Monia Smiti

  Centre Hospitalo-Universitaire La Rabta

  STUDY DIRECTOR

Central Study Contacts

Fatma Saïd

CONTACT

0021671150876; saidzribifatma@yahoo.fr

Fatma Saïd

CONTACT

saidzribifatma@yahoo.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Model Details: double-blind randomized study

Study Record Dates

• First Submitted: March 2, 2024
• First Posted: March 15, 2024
• Study Start: April 15, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: March 15, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share