Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06313905 |
| Other study ID # |
DRYLESS1 |
| Secondary ID |
CHU La Rabta |
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 15, 2024 |
| Est. completion date |
December 31, 2025 |
Study information
| Verified date |
March 2024 |
| Source |
University Tunis El Manar |
| Contact |
Fatma Saïd |
| Phone |
0021671150876 |
| Email |
saidzribifatma[@]yahoo.fr |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
Study design:
This is a randomized controlled double-blind clinical trial involving 2 groups:
- Group 1: consisting of 90 patients receiving the EVADRY dietary supplement treatment.
- Group 2: consisting of 90 patients receiving a placebo
Inclusion and exclusion criteria:
• Inclusion criteria:
The included patients meet the following criteria:
- 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
• Non-inclusion criteria:
- allergy or hypersensitivity to any of the products
- pregnancy
- breastfeeding
- oral or throat surgery before wound healing
- cognitive or dementia disorders
- Exclusion criteria:
These include:
- Occurrence of cognitive or dementia disorders
- Pregnancy
- Allergy to any of the components of the EVADRY product
- Indication of oral or throat surgery
Randomization:
This is a randomization by random blocks. A co-investigator (who is not in contact with the
patients) will be responsible for this randomization. The EVADRY treatment and the placebo
will have the same packaging. Codes will be assigned to the sprays by the investigator
responsible for the randomization. These codes will be placed in sealed envelopes and will
only be opened at the end of the study. They will be kept by another investigator who has no
knowledge of the randomization.
Treatment and interventions:
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).
- 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.
Evaluation criteria:
• Primary evaluation criterion: It is based on the measurement of 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.
• Secondary evaluation criteria:
- Xerostomia Inventory in French version: it is a questionnaire composed of 11 questions.
For each item, there is an evaluation of its frequency (never, rarely, occasionally,
quite often, very often). The total score ranges from 11 to 55 points.
- OHIP-14 questionnaire: it includes 7 dimensions with 14 items to assess quality of life.
The higher the score on this questionnaire, the more negative the impact on quality of
life.
- HAD scale: it is an instrument that allows screening for anxiety and depressive
disorders. It consists of 14 items rated from 0 to 3 : 7 for anxiety and 7 for
depression. We will have 2 scores. A score ≤7 corresponds to the absence of symptoms,
≥11 corresponds to definite symptomatology, and between the two, it is doubtful.
- Buccal Schirmer test: it consists of a strip of Whatman paper (blotting paper) placed in
a polyethylene bag, with the first 5 mm of the strip protruding from one end of the bag.
This end is then folded and placed under the patient's tongue in contact with the floor
of the mouth for 5 minutes. The patient should be in a forward-leaning position, hands
on knees, and eyes closed. After five minutes, the strip is removed and the soaked
portion is measured in centimeters.
Patient follow-up:
The patients will be interviewed and examined initially. During this consultation, the
patient's epidemiological and clinical data will be collected. During the same consultation,
SFR and buccal Schirmer test will be measured, and Xerostomia Inventory, OHIP-14, and HAD
will be calculated.
These tests will be repeated at 1, 2, and 3 months.
Interruption and end of the trial:
Patient follow-up is planned for 3 months. The statistical study is planned for 1 month.
