Evaluation of the effect of Glycyrrhiza glabra extract in the form of D-Reglis herbal pills on amount of human Saliva: A Crossover randomized clinical trial study
Evaluation of the effect of Glycyrrhiza glabra extract in the form of D-Reglis herbal pills on amount of human Saliva
Design
Randomized clinical trial by block randomization with cross-over groups, phase 3. Double-Blind side. The sample size is 20.
Settings and conduct
This research was a cross-over , randomized and double blind study. The population of the study included healthy individuals aged 18 to 35 years old, including individuals who refer to the dental clinic of North Khorasan University of Medical Sciences and students of this college randomly entered the study as the two experimental and control groups.2 capsules containing extract of licorice (D-Reglis tablet 380mg) or placebo (starch) were administered orally with 200 mL water.
Saliva samples were then collected according to a spitting method at scheduled times.
After a 2-week wash-out period, in the second phase, the switch between two groups was performed and the saliva was collected as in the first phase.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Healthy volunteers who have no history of dry mouth,No subject received any medication during 1 month before the study,Signature of the informed consent form
Non-inclusion criteria: subjects who suffer from dry mouth and take medication
, Sensitivity to licorice ,Pregnancy,Use cigarettes.
Intervention groups
Give the D-reglis tablet to the intervention group
Give starch tablet to the control group
Main outcome variables
Weight of saliva
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190422043344N1
Registration date:2019-06-17, 1398/03/27
Registration timing:retrospective
Last update:2019-06-17, 1398/03/27
Update count:0
Registration date
2019-06-17, 1398/03/27
Registrant information
Name
Mehdi mohammad sadeghian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 58 3226 1272
Email address
m.sadeghian@nkums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-03-05, 1397/12/14
Expected recruitment end date
2019-03-19, 1397/12/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of Glycyrrhiza glabra extract in the form of D-Reglis herbal pills on amount of human Saliva: A Crossover randomized clinical trial study
Public title
" Effect of Glycyrrhiza glabra extract on salivary volume"
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Healthy volunteers who have no history of dry mouth
aged 18-35 years
Signature of informed consent form
Exclusion criteria:
1- Pregnancy
2. Those who suffer from dry mouth and take medication
3. Sensitivity to licorice
4- Use of cigarettes
5- Drug use in the previous month before the study
Age
From 18 years old to 35 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
20
More than 1 sample in each individual
Number of samples in each individual:
2
Every person participating in the study at the beginning of the study drug and take placebo two weeks later
Randomization (investigator's opinion)
Randomized
Randomization description
The subjects were divided into two groups A and B according to a randomized double blind block design.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this double-blind study, participants, researchers are unaware of prescription drugs.
Placebo
Used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
National commitee of North khorasan University of medical sciences
Street address
Shahriar Ave., North khorasan University of Medical Sciences
City
Bojnourd
Province
North Khorasan
Postal code
9417694735
Approval date
2019-03-05, 1397/12/14
Ethics committee reference number
IR.NKUMS.REC.1397.099
Health conditions studied
1
Description of health condition studied
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The weight of saliva secreted from all salivary glands in the mouth
Timepoint
Measurement of saliva volume at the beginning of the study and at 20, 40, 60, 90, 120, and 180 minutes after the administration of the D-REGLIS tablet and placebo
Method of measurement
digital Balance
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: A single dose of 380 milligrams of licorice extract produced by Iran Daruk Co., with 200 cc was prescribed.To prevent the bias between the drug and the placebo, they are placed in the same capsules.
Category
Treatment - Drugs
2
Description
Control group: Placebo (starch), in capsules of the same size and shape as capsules of the drug, and with 200 cc of water was prescribed.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
North Khorasan University of Medical Sciences
Full name of responsible person
Mehdi Mohammad Sadeghian
Street address
Shahriar Ave.; North Khorasan University of Medical Sciences
City
Bojnourd
Province
North Khorasan
Postal code
74877-94149
Phone
+98 58 3229 6764
Email
dr.mm.sadeghian@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Bojnourd University of Medical Sciences
Full name of responsible person
Seyed Kaveh Hojjat
Street address
North Khorasan University of Medical Sciences, Shahriar st, Bojnord
City
Bojnourd
Province
North Khorasan
Postal code
9417694735
Phone
+98 58 3224 6144
Email
dr.mm.sadeghian@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bojnourd 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
Bojnourd University of Medical Sciences
Full name of responsible person
Mehdi Mohammad Sadeghian
Position
student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Shahriar St., North Khorasan University of Medical Sciences
City
Bojnourd
Province
North Khorasan
Postal code
9417694735
Phone
+98 58 3226 1272
Email
dr.mm.sadeghian@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bojnourd University of Medical Sciences
Full name of responsible person
Mehdi Mohammad Sadeghian
Position
student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Shahriar St., North Khorasan University of Medical Sciences
City
Bojnourd
Province
North Khorasan
Postal code
9417694735
Phone
+98 58 3624 5629
Email
dr.mm.sadeghian@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Bojnourd University of Medical Sciences
Full name of responsible person
Mehdi Mohammad Sadeghian
Position
student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Shahriar st., North Khorasan University of Medical Sciences
City
Bojnourd
Province
North Khorasan
Postal code
9417694735
Phone
+98 58 3624 5629
Email
dr.mm.sadeghian@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Information about the main consequence, have the ability to share, after unidentifiable people.
When the data will become available and for how long
Start the access period 6 months after printing the results
To whom data/document is available
Researchers working in academic & scientific institutions
Under which criteria data/document could be used
The use of data in order to complete scientific information and research is permissible and sending a request for access to data has not a specific condition.
From where data/document is obtainable
1.North Khorasan University of Medical Sciences, dental College 2. s.etemadzade@gmail.com
What processes are involved for a request to access data/document
After sending the email, it will be answered for a few days