IRCT
Iranian Registry of Clinical Trials
- Beta version
Home
Search trials
Help
Login
Apply for membership
Home
Approved trials
» فارسی
History
Protocol summary
General information
Secondary Ids
Ethics committees
Health conditions studied
Primary outcomes
Secondary outcomes
Intervention groups
Recruitment centers
Sponsors / Funding sources
Person responsible for general inquiries
Person responsible for scientific inquiries
Person responsible for updating data
Sharing plan
Camparision of the 1% and 2% Pilocarpin mouthwash on xerostomic pathient
View the latest revision
History
#
Registration date
Revision Id
2
2022-05-18, 1401/02/28
226726
1
2021-03-03, 1399/12/13
173589
Changes made to previous revision
This is the first revision
Protocol summary
Study aim
Camparision of the 1% and 2% Pilocarpin mouthwash on xerostomic pathient
Design
48 pathients in 3 grops, every grop 16 patheint Duble bilind
Settings and conduct
Dental university
Participants/Inclusion and exclusion criteria
xerostomic pathient
Intervention groups
G1: 1% Pilocarpin mouthwash G2: 2% Pilocarpin mouthwash G3: 0% Pilocarpin mouthwash
Main outcome variables
Reduce of xerostomia
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:
IRCT20210208050302N1
Registration date:
2021-03-03, 1399/12/13
Registration timing:
prospective
Last update:
2021-03-03, 1399/12/13
Update count:
1
Registration date
2021-03-03, 1399/12/13
Registrant information
Name
babak motamed
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2232 6172
Email address
alaee.a@iautmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-09, 1400/01/20
Expected recruitment end date
2021-08-23, 1400/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Camparision of the 1% and 2% Pilocarpin mouthwash on xerostomic pathient
Public title
Camparision of the 1% and 2% Pilocarpin mouthwash on xerostomic pathient
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
xerostomia
Exclusion criteria:
using drug
Age
From
18 years
old to
65 years
old
Gender
Both
Phase
1-2
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
48
Randomization (investigator's opinion)
Randomized
Randomization description
metod : simple
Blinding (investigator's opinion)
Double blinded
Blinding description
Pathient and me
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Islamic azad university Tehran mediacal branch
Street address
No 1 , Golnar Ave., Pasdaran St.
City
Tehran
Province
Tehran
Postal code
1945643174
Approval date
2021-02-15, 1399/11/27
Ethics committee reference number
IR.IAU.DENTAL.REC.1399.282
Health conditions studied
1
Description of health condition studied
Xerostomia
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Saliva rate
Timepoint
45 & 60 & 75 after intervention
Method of measurement
Absorbent by cotton rules
Secondary outcomes
empty
Intervention groups
1
Description
Control group: Plasbo
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Dental university
Full name of responsible person
Babak Motamed
Street address
No.1, Golnar Ave.,Pasdaran st.
City
tehran
Province
Tehran
Postal code
1945643174
Phone
+98 21 2232 6172
Email
motttamed@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Arezoo Alaee
Street address
No 1, Neyestan 9 Ave., Pasdaran St.
City
tehran
Province
Tehran
Postal code
12329879540
Phone
+98 21 2251 5700
Email
arezoo.alaee@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Babak Motamed
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons
Person responsible for general inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Babak Motamed
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
No 1 , Golnar Ave., Pasdaran St.
City
tehran
Province
Tehran
Postal code
1945643174
Phone
+98 21 2232 6172
Email
motttamed@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Babak Motamed
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
No 1 , Golnar Ave., Pasdaran St.
City
tehran
Province
Tehran
Postal code
1945643174
Phone
+98 21 2232 6172
Email
motttamed@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Babak Motamed
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
No.1,golnar Ave.,Pasdaran St.
City
Tehran
Province
Tehran
Postal code
1945643174
Phone
+98 21 2232 6172
Fax
Email
alaee.a@iautmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
I nedd consultion
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
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Loading...