Ignite Creation Date:
2024-05-06 @ 8:15 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06313905
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-15
First Post:
2024-03-02
Brief Title:
EVADRY in the Treatment of Xerostomia in Sjögrens Syndrome
Sponsor:
University Tunis El Manar
Organization:
University Tunis El Manar
Study Overview
Official Title:
DRYLESS Randomized Controlled Trial of EVADRY vs Placebo in the Treatment of Xerostomia in Sjögrens Syndrome
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DRYLESS
Brief Summary:
Xerostomia is a common and very bothersome manifestation that impairs the quality of life in Sjogrens 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 n90 and a placebo arm n90 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
Detailed 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 Sjogrens syndrome according to ACREULAR 2016 criteria
continuous xerostomia for more than 3 months
initial salivary flow rate 01 mlmin
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 01 mlminute 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 patients 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 patients 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
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 Sjogrens syndrome according to ACREULAR 2016 criteria
continuous xerostomia for more than 3 months
initial salivary flow rate 01 mlmin
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 01 mlminute 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 patients 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 patients 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CHU La Rabta | OTHER | La Rabta hospital | None |