Evaluating the effect of Tabashir mucoadhesive paste on management of oral ulcers in rheumatic patients
Design
Both drugs are given three times a day and every 8 hours to the extent that they cover the surface of the lesion and for 5 days to the patients of the desired groups and finally both groups in terms of amount and duration Recovery time is checked on days 0, 3 and 5. People's oral wounds are examined in the office with a flashlight, and they are photographed with a camera (16 megapixels) and examined in image j software.
Settings and conduct
This study is conducted in rheumatism patients referred to Javad Al-Aameh clinic with manifestations of oral ulcers and by obtaining written consent from them. Patients are divided into two groups of 25 people by random block randomization method. From these two groups:
1- The first group is treated by common medicine (triamcinolone paste).
2- The second group is treated with oral paste containing Tabashir.
Participants/Inclusion and exclusion criteria
Inclusion criteria: occurrence of oral ulcers in rheumatic patients (including canker sores, ulcers caused by lupus; Sjögren's, Behcet's and spondyloarthropathies) and exclusion criteria: patients with ulcers following chemotherapy; presence of oral candidiasis.
Intervention groups
Referrals are divided into two groups, and each group is treated and examined by one of the following:
1) Patients treated with triamcinolone paste (3 times a day); 2) Patients treated with formulations containing Tabashir (3 times a day).
Main outcome variables
The duration of recovery of mouth ulcers; the duration of recovery of a person's problems in speaking; the duration of recovery of a person's problems in eating normal foods and other foods based on hardness and softness.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180114038356N4
Registration date:2024-05-13, 1403/02/24
Registration timing:prospective
Last update:2024-05-13, 1403/02/24
Update count:0
Registration date
2024-05-13, 1403/02/24
Registrant information
Name
Somayyeh Karami-Mohajeri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3132 5001
Email address
somayyehkarami@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-07-13, 1403/04/23
Expected recruitment end date
2024-10-14, 1403/07/23
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effect of Tabashir mucoadhesive paste on management of oral ulcers in rheumatic patients
Public title
Evaluating the effect of Tabashir mucoadhesive paste on management of oral ulcers in rheumatic patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with lupus suffer from oral ulcers
Patients with Sjogren's suffer from oral ulcers
Patients with Behcet's disease suffer from oral ulcers
Patients with spondyloarthropathies suffer from oral ulcers
Exclusion criteria:
Patients with ulcers following chemotherapy
Presence of oral candidiasis
Age
From 18 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
50 patients are divided into 5 blocks of 10 using random block randomization. From each block, 5 people will be randomly treated with common medicine (triamcinolone paste) and 5 other people will be treated with oral paste containing Tabashir.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kerman University of Medical Sciences
Street address
Kerman University of Medical Sciences, Medical University Campus, Haft-Bagh Highway, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7616913555
Approval date
2023-10-23, 1402/08/01
Ethics committee reference number
IR.KMU.REC.1402.264
Health conditions studied
1
Description of health condition studied
Rheumatic patients with oral ulcers
ICD-10 code
M79.0
ICD-10 code description
Rheumatism, unspecified
Primary outcomes
1
Description
Investigating the effect of Tabashir adhesive mucus paste on the healing of oral ulcers
Timepoint
Before intervention and 3, 5 days after intervention
Method of measurement
Questionnaires
Secondary outcomes
1
Description
Intensity of pain
Timepoint
Before intervention and 3, 5 days after intervention
Method of measurement
Questionnaires: Numerical Pain Rating Scale(NPRS)
2
Description
Degree and area of mouth ulcer
Timepoint
Before intervention and 3, 5 days after intervention
Evaluation of difficulties in speaking, eating normal foods and other foods based on hardness and softness
Timepoint
Before intervention and 3, 5 days after intervention
Method of measurement
Questionnaires based on Likert scale
4
Description
Size of oral lesions in terms of redness and inflammation
Timepoint
Before intervention and 3, 5 days after intervention
Method of measurement
میزان تغییر(کاهش یا افزایش) در اندازه ضایعات دهانی در طی درمان(بر اساس عکس برداری از ضایعات و شکایات بیمار مانند درد، سوزش، دیس فاژی و...) که به عنوان درصد تغییر درنظر گرفته خواهد شد: هیچ: کاهش>40%، خفیف: 30-39%، متوسط: 20-29%، شدید: 10-19%، بسیار شدید: تغییری نکند یا کاهش کمتر از 9% باشد یا هرگونه افزایش سایز
Intervention groups
1
Description
Intervention group: 25 Rheumatoid patients with oral ulcers receive the desired drug (Tebashir mucoadhesive paste, three times a day for 5 days)
Category
Treatment - Drugs
2
Description
Control group: 25 rheumatic patients with oral ulcers receive the common drug (triamcinolone, three times a day for 5 days)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Kerman Javadalaimeh Clinic
Full name of responsible person
Somayyeh Karami-Mohajeri
Street address
Kerman University of Medical Sciences, Medical University Campus, Haft-Bagh Highway
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5001
Email
somayyehkarami@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Vice Chancellor for Research: Abedin Iran pour
Street address
Kerman University of Medical Sciences, Medical University Campus, Haft-Bagh Highway
City
Kerman
Province
Kerman
Postal code
7619813159
Phone
+98 34 3226 3719
Fax
+98 34 3226 3857
Email
KMU_RESEARCH@YAHOO.COM
Web page address
https://vresearch.kmu.ac.ir/fa
Grant name
Kerman University of Medical Sciences
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Somayyeh Karami-Mohajeri
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Toxicology
Street address
Kerman University of Medical Sciences, Medical University Campus, Haft-Bagh Highway
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5001
Email
somayyehkarami@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Somayyeh Karami-Mohajeri
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Toxicology
Street address
Kerman University of Medical Sciences, Medical University Campus, Haft-Bagh Highway
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5001
Email
somayyehkarami@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Somayyeh Karami-Mohajeri
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Toxicology
Street address
Kerman University of Medical Sciences, Medical University Campus, Haft-Bagh Highway
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5001
Email
somayyehkarami@gmail.com
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