Comparison the effect of mouthwash with pure water and licorice on dry mouth of hemodialysis patients
Design
A cross over randomized clinical trial study was conducted on witness and control group without blindness
Settings and conduct
This study was a cross-over randomized clinical trial study and the research population is hemodialysis patients referring to the dialysis department of Shahid Hasheminejad Hospital which are in witness and control groups without blindness. The control groups do mouthwash eleven-day with simple water and compare groups with licorice. On the second 11 day, none of the two groups do not do mouthwash. In the third 11 day the control group instead of licorice used water for mouthwash and witness group used licorice instead of water
Participants/Inclusion and exclusion criteria
People with advanced kidney failure undergoing regular hemodialysis (with the same weekly sessions) that complain of dry mouth in the last 4 weeks. Patients should be very alert and have the ability to mouthwash properly, People should not be sensitive to mouthwash, the absence of Sjögren's syndrome is confirmed by a doctor, the absence of systolic blood pressure above 160 mmHg and diastolic pressure above 95 mm Hg, lack of weight gain more than 5% between two sessions of dialysis, do not taking diuretic, Tricyclic antidepressants, Anticholinergic, antihistamine, Anti-angina in the last week.
Intervention groups
Evaluation of the efficacy of oral licorice mouthwash (control group), and mouthwash (Witness group) in advanced kidney failure patients that complain of dry mouth in the last 4 weeks and have the ability to do mouthwash
Main outcome variables
Reducing and removing dry mouth with water and licorice
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180828040890N1
Registration date:2018-12-16, 1397/09/25
Registration timing:retrospective
Last update:2018-12-16, 1397/09/25
Update count:0
Registration date
2018-12-16, 1397/09/25
Registrant information
Name
marzieh fesdeghchi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4365 1617
Email address
fesdeghchi.m@tak.iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-07-23, 1397/05/01
Expected recruitment end date
2018-08-21, 1397/05/30
Actual recruitment start date
2018-08-01, 1397/05/10
Actual recruitment end date
2018-08-16, 1397/05/25
Trial completion date
2018-09-01, 1397/06/10
Scientific title
Comparison the effect of mouthwash with pure water and licorice on dry mouth of hemodialysis patients
Public title
- Comparison the effect of mouthwash with water and licorice on dry mouth of dialysis patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
People with advanced kidney failure undergoing regular hemodialysis (with the same weekly sessions) that complain of dry mouth in the last 4 weeks and have the ability to do mouthwash
Exclusion criteria:
The patient's unwillingness to continue to participate in the study sensitivity to mouthwash licorice. Start medications that cause dry mouth during the study (Antihypertensive, antidepressant, diuretic, anticholinergic, and antihistamine)
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
74
More than 1 sample in each individual
Number of samples in each individual:
2
Every person participating in the study does mouthwash eleven-day with simple water and the next eleven days with licorice
Actual sample size reached:
66
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, patients were entered the study by available method and randomly divided into two groups (water, licorice) by block assignment. Thus, the letter A to water, the letter B, is assigned to licorice, and then possible
conditions were written on cards and placed on the table. For each group, two of the patients who entered the study according to availability, a replacement card was taken by the researcher and placed in order of letters; the patients were divided in two groups. This process continued until the desired sample size was provided.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Iran University of Medical Sciences
Street address
Hemmat Highway, next to Milad Hospital and Razi congress center, Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2017-07-17, 1396/04/26
Ethics committee reference number
IR.IUMS.FMD.REC.1396.9411449005
Health conditions studied
1
Description of health condition studied
Dry mouth
ICD-10 code
R68.2
ICD-10 code description
خشکی دهان
Primary outcomes
1
Description
Thomson questionnaire Oral dry mouth score in 2014
Timepoint
At the study, on the fifth and eleventh day after using water and licorice
Method of measurement
Thomson Oral questionnaire 2014 For dry mouth, 5 questions include: 1- Feeling dry in my mouth 2- When I'm eating, I feel dry in my mouth,3- I have a feeling of dryness in the mouth when eating dry foods,4- I wake up at night for drinking 5- To swallow food, I should eat some water. Each answer is 5 questions using Likert 1- never 2- never ,hardly3- sometimes,4- frequently5- Always and the score of 25 is the highest score which shows the highest levels of dry mouth. And the 5 was lowest score without dry mouth
Secondary outcomes
empty
Intervention groups
1
Description
The intervention group, used licorice and compare group used water at first 11 day. At this time each group used the solution 3 times (half an hour). After a meal, the mouthwash solution was taken and half an hour after the mouthwash, they do not eat anything and do not swallow mouthwash and they are thrown it out of mouth completely. The second 11 day, any mouthwash is used by the two groups. In the third stage of intervention mouthwash solution of two groups is displaced. Intervention group used water and compare group used licorice. Material used was licorice root powder that dissolved 5 grams per 500 cc in water and each time the solution was shaken to form a uniform solution. Licorice root is prepared by the expert of the traditional medicine pharmacist of the Faculty of Traditional Medicine, Dr. Ali Ghobadi, from Tehran's Great Market. In people with regime and absence of three main meals, is done three times mouthwash with an interval of 6-4 hours. Duration of mouthwash was two 11-days for each group and in second 11-day of study mouthwash with water and licorice, each group was completed Thomson's mouthwash questionnaire on fifth and eleventh day of the study
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
بخش دیالیز بیمارستان شهید هاشمی نژاد تهران
Full name of responsible person
Kazem Malakoti
Street address
Valiasr Ave above Vanak Square, Valisada St
City
Tehran
Province
Tehran
Postal code
۱۹۶۹۷۱۴۷۱۳
Phone
+98 21 8864 4441
Email
PR@iums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Kazem Malakoti
Street address
Hemmat Highway, next to Milad Hospital and Razi congress center, Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
14665-354
Phone
+98 21 8805 2248
Email
PR@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
fesdeghchi Marzieh
Position
Nursing student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Valiasr Street, Rashid Yasemi Street
City
Tehran
Province
Tehran
Postal code
۱۹۹۶۷۱۳۸۸۳
Phone
+98 21 8820 1987
Email
fesdeghcji.m@tak.iums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Zhale mohammad-aliha
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
- Valiasr Street, Rashid Yasemi Street
City
Tehran
Province
Tehran
Postal code
۱۹۹۶۷۱۳۸۸۳
Phone
+98 21 8820 1978
Email
mohammadaliha.j@iums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Fesdeghchi Marzieh
Position
Nursing Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
- Valiasr Street, Rashid Yasemi Street
City
Tehran
Province
Tehran
Postal code
196713883
Phone
+98 21 8820 1987
Email
fesdeghchi.m@tak.iums.ac.ir
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
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is 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
The total potential data is being shared in non-identifiable condition
When the data will become available and for how long
After the publication of the paper resulted from the study
To whom data/document is available
Researchers and others
Under which criteria data/document could be used
According to the study
From where data/document is obtainable
Mail to the responsible for the trial update
What processes are involved for a request to access data/document