Determination of the effect of Ginger and Aloe vera mouthwashes on xerostomia of patients with diabetes mellitus referred to diabetes clinic of Bandar Abbas in 2019
Design
A clinical trial with a control group, with parallel group design, triple-blind, randomized using the random numbers table. There are three groups: 1- Aloe Vera mouthwashe 2- ginger mouthwash and 3- normal saline mouthwash (placebo) .The sample size in each group is 35 people. Blinding: All three mouthwashes will be produced by the Barij pharmaceutical company in similar packaging with different A, B and C codes. The researcher, the patients, and the statistical analyst will not know which code corresponds to which mouthwash (triple-blind ) and just, a non-beneficiary person out of the project, is aware of the content of the bottles. After completing the statistical analysis, the codes will be decoded by him.
Settings and conduct
In this triple blind clinical trial, among diabetic patients referred to Bandar Abbas Diabetes clinic, 105 people who meet the inclusion criteria, randomly were placed into one of three groups. All three groups use 20 ml of mouthwash three times a day, for 14 days.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Diabetic patients with dry mouth According to tools;
The tendency to participate in the study;
the ability to use mouthwash.
Non-inclusion criteria: Pregnancy; known allergies to ginger or aloe vera; existence of ulcers or oral infections; having high physical activity; using mouthwash or artificial saliva.
Intervention groups
Intervention group 1: Aloe Vera mouthwash.
Intervention group 2: ginger mouthwash.
control group: normal saline mouthwash (placebo).
Patients in each group will use their mouthwash 20ml three times a day, for 14 days.
Main outcome variables
Dry mouth
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181209041899N1
Registration date:2019-10-24, 1398/08/02
Registration timing:registered_while_recruiting
Last update:2019-10-24, 1398/08/02
Update count:0
Registration date
2019-10-24, 1398/08/02
Registrant information
Name
Forouzande Badooei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 76 3366 6367
Email address
forouzande21@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-23, 1398/07/01
Expected recruitment end date
2019-12-22, 1398/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative study on the effect of Ginger and Aloe vera mouthwashes on xerostomia among patients with diabetes mellitus
Public title
The effect of Ginger and Aloevera mouthwashes on xerostomia
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Diabetic patients with dry mouth according to the tools
The tendency to participate in the study
the ability to use mouthwash
Exclusion criteria:
pregnancy
known allergies to ginger or aloe vera
existence of ulcers or oral infections
having high physical activity
use of mouthwash or artificial saliva
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
105
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be done using a random number table that is derived from the Randomization Main software.
Blinding (investigator's opinion)
Triple blinded
Blinding description
All three mouthwashes will be produced by Kashan Barij Essans Pharmaceutical Company in similar packages with different codes A, B or C. The researcher, patients, and statistical analyst will be unaware of which code corresponds to which mouthwash (three blind), and only a non-beneficiary person outside the project is aware of the contents of the bottles and after statistical analysis, the codes will be decoded by him.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee oh Hormozgan University of Medical Sciences
Street address
Nursing and Midwifery faculty, Southern Resalat, Golshahr
City
Bandar Abbas
Province
Hormozgan
Postal code
7919693116
Approval date
2019-02-25, 1397/12/06
Ethics committee reference number
IR.HUMS.REC.1397.299
Health conditions studied
1
Description of health condition studied
dry mouth (xerostomia)
ICD-10 code
K11.7
ICD-10 code description
Disturbances of salivary secretion
Primary outcomes
1
Description
Oral dry mouth score based on visual analog scale
Timepoint
Measuring the amount of oral dry mouth before the intervention and 14 days after using mouthwash (after the end of the intervention)
Method of measurement
Standard questionnaire for oral dry mouth and visual analog scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: The recipient of 50% Aloe Vera mouthwash, prepared by Barij Essance Pharmaceuticals, 20 ml, three times daily for 60 seconds (preferably after meals) Duration of use of mouthwashe is 14 days
Category
Treatment - Other
2
Description
Intervention group 2: The recipient of 25% ginger mouthwash, prepared by Barij Essance Pharmaceuticals, 20 ml, three times daily for 60 seconds (preferably after meals) Duration of use of mouthwashe is 14 days
Category
Treatment - Other
3
Description
Control group: The recipient of Normal Saline mouthwash, prepared by Barij Essance Pharmaceuticals, 20 ml, three times daily for 60 seconds (preferably after meals) Duration of use of mouthwashe is 14 days
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Diabetes clinic of Bandar Abbas
Full name of responsible person
Elham Imani
Street address
Shahid Mohammadi Hospital; Gomhouri Eslami Blvd
City
Bandar Abbas
Province
Hormozgan
Postal code
7919693116
Phone
+98 76 3334 7000
Email
shmh@hums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Teymoor Aghamollaei
Street address
Nursing and Midwifery faculty, Southern Resalat, Golshahr
City
Bandar Abbas
Province
Hormozgan
Postal code
7919693116
Phone
+98 76 3366 6367
Email
shmh@hums.ac.ir
Grant name
Thesis
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bandare-abbas University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Elham Imani
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nursing and Midwifery faculty, Southern Resalat, Golshahr
City
Bandar Abbas
Province
Hormozgan
Postal code
7919693116
Phone
+98 763366367
Email
forouzande21@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Forouzande Badooei
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Nursing and Midwifery faculty, Southern Resalat, Golshahr
City
Bandar Abbas
Province
Hormozgan
Postal code
7919693116
Phone
+98 763366367
Email
forouzande21@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Forouzande Badooei
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Nursing and Midwifery faculty, Southern Resalat, Golshahr
City
Bandar Abbas
Province
Hormozgan
Postal code
7919693116
Phone
+98 763366367
Email
forouzande21@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Only information about the outcome
When the data will become available and for how long
Since 1399
To whom data/document is available
researchers
Under which criteria data/document could be used
Use of the data is permitted with the written permission of the responsible author and with the citation of the source.
From where data/document is obtainable
Dr Elham Imani
What processes are involved for a request to access data/document
Access to the data file will be possible by sending a request to the author's email.