the effect of mouthwash containing Tabashir on oral ulcers in paraquat poisoning
Design
This is a clinical trial study that in a period of10 months after obtaining the irct code to the poisoning department of Afzalipour Medical Education Center in Kerman. after obtaining written consent from them, to three groups of 10 people with the method Randomization blocks are randomly divided and the study is open label
Settings and conduct
1) will be treated with triamcinolone paste: 3 times a day every 8h for one month, to the extent that the wound surface is covered
2) will be treated and examined with mouthwash made from the combination of aluminum hydroxide + lidocaine + diphenhydramine:10cc of it is given to each person for one month 3 times every 8h
3) will be treated with Tabashir containing mouthwash: 10cc of it is given to each person for a month in 3 occasions every 8h.
Participants/Inclusion and exclusion criteria
The criteria for inclusion the study include: occurrence of oral and pharyngeal ulcers in the victim, and the exclusion criteria are the presence of symptoms of esophageal perforation, frequent nausea and vomiting in the person, and chronic hypotension.
Intervention groups
1) Patients treated with triamcinolone paste
2) Patients treated with the combination of aluminum hydroxide + lidocaine + diphenhydramine
3) Patients treated with formulations containing Tabashir
Main outcome variables
Determining and comparing the duration of recovery of speech problems, discomfort while opening and moving one's mouth, problems in swallowing, eating normal foods, soft and hard foods, determining and comparing the process of reducing the number of areas involved in the mouth, the percentage of changes in the size of oral lesions (lips and oral mucosa), determining and comparing the healing time of oral ulcers in different groups
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180114038356N5
Registration date:2024-06-11, 1403/03/22
Registration timing:registered_while_recruiting
Last update:2024-06-11, 1403/03/22
Update count:0
Registration date
2024-06-11, 1403/03/22
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
2024-04-06, 1403/01/18
Expected recruitment end date
2024-12-21, 1403/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of mouthwash containing Tabashir (Saccharum Ravennae) extract on oral mucosal ulcers in case of paraquat poisoning
Public title
The effect of mouthwash containing Tabashir extract on oral ulcers in paraquat poisoning
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Occurrence of oral and pharyngeal wounds in the injured
Exclusion criteria:
Symptoms of esophageal perforation
Frequent nausea and vomiting in a person
Chronic hypotension
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
The eligible participants are allocated to 1 of 3 study groups in 1:1:1 ratio with a block size of 3. A person (not involved in the trial) generates an allocation sequence.
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
Ethics Committee of Kerman University of Medical Sciences
Street address
University of Medical Sciences campus, The beginning of Haft Bagh Alavi axis
City
Kerman
Province
Kerman
Postal code
7616913555
Approval date
2023-12-04, 1402/09/13
Ethics committee reference number
IR.KMU.REC.1402.318
Health conditions studied
1
Description of health condition studied
paraquat poisening
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Duration of recovery of oral ulcer, amount of pain, change in lesion size, duration of recovery of dysphagia, duration of recovery of difficulty in eating normal food, duration of recovery of difficulty in moving the mouth, duration of reduction of the affected areas in the mouth
Timepoint
Before intervention, 7, 14, 21, 28 days after intervention
Method of measurement
There is no valid scoring system that exclusively measures the severity of oral lesions and the extent of involvement, except for the Oral Disease Severity Score (ODSS), which also has problems and cannot easily express the degree of erosion or ulceration; As a result, the Pemphigus Oral Lesions Intensity Score (POLIS) scale can be used, it is worth mentioning that we have examined 7 of the 16 items in the POLIS scale: 1) the amount of change (decrease or increase) in the size of oral lesions during treatment 2) difficulty in eating normal food 3) examination of difficulty in eating food according to its consistency 4) difficulty in speaking 5) difficulty in swallowing 6) number of areas involved in the oral cavity 7) discomfort while opening and moving the mouth
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: triamcinolone paste : 3 times a day every 8 hours to the extent that the wound surface is covered
Category
Treatment - Drugs
2
Description
Intervention group: mouthwash made from the combination of aluminum hydroxide + lidocaine + diphenhydramine : Each person is given 10 cc of it in 3 times every 8 hours for a month
Category
Treatment - Drugs
3
Description
Intervention group: mouthwash containing Tabashir : This mouthwash is obtained by dissolving 15 grams of Tabashir per 10 cc of water and is given to each person for a period of one month. 10 cc of it is given 3 times a month every 8 hours
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Kerman university of medical science
Full name of responsible person
Somayyeh Karami-Mohajeri
Street address
University of Medical Sciences campus, The beginning of Haft Bagh Alavi axis
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5700
Email
f.zamani@gmail.com
Web page address
http://www.kmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Abedin Iranpour
Street address
Dept Health Services, Faculty of Health, Kerman University of Medical Sciences compus, at the beginning of Haft Bagh Blvd, Kerman
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5098
Fax
+98 34 3132 5605
Email
iranpourabedin89@gmail.com
Web page address
http://www.kmu.ac.ir
Grant name
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
Assistance prof.
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of Pharmacy, Kerman University of Medical Sciences, Haft Bagh-e-Alavi Highway, Kerman, 7616911319, Iran
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5001
Fax
+98 34 3132 5003
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
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Toxicology
Street address
Haft-Bagh Highway
City
kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5001
Email
somayyehkarami@gmail.com
Web page address
http://kmu.ac.ir/en
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Somayyeh Karami-Mohajeri
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Toxicology
Street address
Haft-Bagh Highway
City
kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5001
Email
somayyehkarami@gmail.com
Web page address
http://kmu.ac.ir/en
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