Preparation and clinical trial of Mucoadhesive Polymeric Gel Containing Syzygiumaromaticum, Glycyrrhizaglabra, Punicagranatum L. Extract for Treatment of Oral Aphthae
Preparation and clinical trial of Mucoadhesive Polymeric Gel Containing Syzygiumaromaticum, Glycyrrhizaglabra, Punicagranatum L. Extract for Treatment of Oral Aphthae
Design
patients with aphthous ulcers with at least 5 years old
Settings and conduct
Faculty of pharmacy. Zanjan university of medical sciences
Participants/Inclusion and exclusion criteria
patients with aphthous ulcers with at least 5 years old
Intervention groups
Description: Placebo group: 20 patients with oral aphthous, receiving placebo gel , three times a day, after breakfast and lunch and before sleeping at night, for 7 days
Category: Placebo
Description: Intervention group: 20 patients with oral aphthous, receiving medical gel ( Mucoadhesive Gel Containing Syzygium aromaticum, Glycyrrhiza glabra, Punica granatum L. Extract), three times a day, after breakfast and lunch and before sleeping at night, for 7days
Category: Treatment - Drugs
Main outcome variables
Primary outcomes
Description:The amount of oral aphthous resized in response to treatment with medical gel ( Mucoadhesive Gel Containing Syzygium aromaticum, Glycyrrhiza glabra, Punica granatum L. Extract)
Timepoint: In the first visit and after 2,4 and 7 days next
Method of measurement: With colis the largest diameter of the oral aphthous is measured and anatomical position is recorded
Secondary outcomes
Description:Pain score during the treatment
Timepoint: At the first session of treatment, 2 ,4 and7 days next
Method of measurement:A score 0 to 10 will be given by the patient
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220731055591N1
Registration date:2022-11-02, 1401/08/11
Registration timing:registered_while_recruiting
Last update:2022-11-02, 1401/08/11
Update count:0
Registration date
2022-11-02, 1401/08/11
Registrant information
Name
Alireza Yazdinezhad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 24 3344 8713
Email address
yazd1387@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-08-13, 1401/05/22
Expected recruitment end date
2023-11-13, 1402/08/22
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Preparation and clinical trial of Mucoadhesive Polymeric Gel Containing Syzygiumaromaticum, Glycyrrhizaglabra, Punicagranatum L. Extract for Treatment of Oral Aphthae
Public title
Preparation and clinical trial of Mucoadhesive Polymeric Gel Containing Syzygiumaromaticum, Glycyrrhizaglabra, Punicagranatum L. Extract for Treatment of Oral Aphthae
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
patients with aphthous ulcers with at least 5 years old
Exclusion criteria:
patients with immunodeficiency disorders
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Sample size
Target sample size:
20
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
The samples were given to the treating physician with a code (code A: Mucoadhesive Polymeric Gel Containing Syzygium aromaticum, Glycyrrhiza glabra, Punica granatum L. Extract and code B: Mucoadhesive Polymeric Gel without Syzygium aromaticum, Glycyrrhiza glabra, Punica granatum L. Extract) , and patients are not aware of the contents of the samples.
Placebo
Used
Assignment
Parallel
Other design features
no
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
ethics committee of Zanjan University of Medical Sciences
Street address
Gavazang Blvd.
City
Zanjan
Province
Zanjan
Postal code
4513983153
Approval date
2022-06-21, 1401/03/31
Ethics committee reference number
IR.ZUMS.REC.1401.139
Health conditions studied
1
Description of health condition studied
oral aphthae
ICD-10 code
K12.0
ICD-10 code description
Recurrent oral aphthae
Primary outcomes
1
Description
Recurrent oral aphthae with at lest 2 mm diameter
Timepoint
every 1 day
Method of measurement
diameter of oral aphthae (mm)
Secondary outcomes
empty
Intervention groups
1
Description
Placebo group: 20 patients with oral aphthous, receiving placebo gel , three times a day, after breakfast and lunch and before sleeping at night, for 7 days
Category
Treatment - Drugs
2
Description
Intervention group: 20 patients with oral aphthous, receiving medical gel ( Mucoadhesive Gel Containing Syzygium aromaticum, Glycyrrhiza glabra, Punica granatum L. Extract), three times a day, after breakfast and lunch and before sleeping at night, for 7days
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Zanjan Faculty of Dentistry
Full name of responsible person
Mahsa Alavi Namvar
Street address
Faculty of Dentistry, Zanjan University of Medical Sciences, Gavazang Blvd.
City
Zanjan
Province
Zanjan
Postal code
4513983153
Phone
+98 24 3301 8623
Fax
+98 24 3301 8624
Email
Mahsa.Alavinamvar@Gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Samad Nadri
Street address
Faculty of Pharmacy, Zanjan University of Medical Sciences, Gavazang Blvd.
City
Zanjan
Province
Zanjan
Postal code
4513983153
Phone
+98 24 3301 8624
Email
Nadri_s@zums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zanjan 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
Zanjan University of Medical Sciences
Full name of responsible person
Faramarz Dobakhti
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Pharmaceutics
Street address
Faculty of Pharmacy, Zanjan University of Medical Sciences, Gavazang Blvd.
City
Zanjan
Province
Zanjan
Postal code
4513983153
Phone
+98 24 3301 8624
Email
Fdobakhti@zums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Faramarz Dobakhti
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Pharmaciutics
Street address
Faculty of Pharmacy, Zanjan University of Medical Sciences, Gavazang Blvd.
City
Zanjan
Province
Zanjan
Postal code
4513983153
Phone
+98 24 3301 8624
Email
Fdobakhti@zums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Faramarz Dobakhti
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Pharmaceutics
Street address
Faculty of Pharmacy, Zanjan University of Medical Sciences, Gavazang Blvd.
City
Zanjan
Province
Zanjan
Postal code
4513983153
Phone
+98 24 3301 8624
Email
Fdobakhti@zums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available