Determining the effects of mouthwash from areal parts Alhagi sp. aerial parts extract on paraquat-induced oral ulcers in poisoned patients
Design
This clinical trial does not have a control group that will be performed on 45 patients. Patients will be randomly divided into three groups of 15 based on a random number table and will be treated without blinding.
Settings and conduct
This study is an interventional and clinical trial that will be performed on 45 poisoned people referred to the poisoning ward of Afzalipour Hospital in Kerman. Given that three groups of 15 people receive standard treatment.
Participants/Inclusion and exclusion criteria
Inclusion conditions include definitive use of paraquat herbicide with toxic dose and patients 'consent to participate in the study and non-entry conditions include poisoning with other herbicides other than paraquat, non-toxic dose of paraquat, patients' lack of cooperation due to oral ulcers, patient dissatisfaction To participate in the study.
Intervention groups
There are three intervention groups: one group with triamcinolone paste (given 3 times a day every 8 hours for a month) and the second group with mouthwash obtained from the combination of aluminum hydroxide + lidocaine + diphenhydramine and the third group with mouthwash containing 0.1 extract. Percentage of Alhagi plant (10 cc of it is given to each person in 3 times every 8 hours for one month) will be treated and examined in order to heal oral ulcers caused by paraquat poisoning.
Main outcome variables
Seven variables are examined during the treatment process: 1. Oral lesions 2. Difficulty in eating food due to its consistency 3. Difficulty in speaking 4. Discomfort while moving the mouth 5. Difficulty in swallowing 6. The number of areas involved in the oral cavity 7. intensity of pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220515054856N1
Registration date:2022-07-23, 1401/05/01
Registration timing:registered_while_recruiting
Last update:2022-07-23, 1401/05/01
Update count:0
Registration date
2022-07-23, 1401/05/01
Registrant information
Name
Faranak Nasiri Majd
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3281 8945
Email address
nasirimajdfaranak@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-06-22, 1401/04/01
Expected recruitment end date
2023-06-22, 1402/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Determining the effects of mouthwash from areal parts Alhagi sp. aerial parts extract on paraquat-induced oral ulcers in poisoned patients
Public title
Determining the effects of mouthwash from areal parts Alhagi sp. aerial parts extract on paraquat-induced oral ulcers in poisoned patients
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
Definitive use of paraquat herbicide with toxic dose (based on history, clinical examination, endoscopic findings)
Patient consent to participate in the study
Exclusion criteria:
Poisoning with other herbicides other than paraquat (based on history, clinical examination, endoscopic findings)
Non-toxic dose of paraquat (endoscopy and normal tests)
Patient dissatisfaction to participate in the study
Patients do not cooperate to take medicine due to mouth ulcers
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
45
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization of the unit is done by block method with a block size of 4. For each of the 6 possible states for the quadruple block, the numbers are assigned as follows: ABBA (3), ABAB (2), AABB (1), BAAB (6), BABA (5), BBAA (4) using the table Random numbers, numbers between 1 and 6 are selected and the treatment allocation list is specified according to each number. To execute the generated random sequence, the method of hiding encoded boxes or cans is used. In this method, the cans are numbered according to a random sequence and inside the boxes, the desired intervention (drug) or a sheet on which the random allocation is written, is provided to the executor with the condition that the boxes are completely sealed and The researcher assigns patients to the standard intervention and treatment group based on the order of patients' admission. Tools: Creating a random sequence of 4 hiding random blocks to execute a random sequence on study participants. How to build: Randomly select the block and read the letters from right to left. The cans are the same weight and shape and will be prepared by an independent researcher.
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
The beginning of Haft Bagh Alavi axis, campus of University of Medical Sciences
City
kerman
Province
Kerman
Postal code
7616913555
Approval date
2022-06-12, 1401/03/22
Ethics committee reference number
IR.KMU.REC.1401.090
Health conditions studied
1
Description of health condition studied
Paraquat herbicide poisoning
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The rate of change (decrease or increase) in the size of oral lesions
Timepoint
3, 7 and 30 days after patient visit and discharge time
From the beginning until the recovery every 4 days
Method of measurement
follow up(Examining the patient and asking the patient)
Secondary outcomes
empty
Intervention groups
1
Description
The first intervention group: Triamcinolone paste (made in Iran, manufacturer: Emad Darman Pars Chemical formula: C21H27FO6) which is given to the patient 3 times a day (every 8 hours) every day for a month to cover the wound surface.
Category
Treatment - Drugs
2
Description
The second intervention group : Aluminum hydroxide mouthwash + lidocaine + diphenhydramine (made in Iran, manufacturer: Iran Hormone), each person is given 10 cc 3 times a day for one month (once every 8 hours).
Category
Treatment - Drugs
3
Description
The third intervention group: Alhagi mouthwash (containing 0.1% of Kharshtar plant extract, made in the laboratory of the Faculty of Pharmacy of Kerman University of Medical Sciences) which is given to each person 3 times a day(once every 8 hours) for one month,amount of 10 CC is given from it.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Afzalipour Hospital, Kerman
Full name of responsible person
Faranak Nasiri Majd
Street address
Imam Khomeini Highway, next to Shahid Bahonar University, Afzalipour Educational and Medical Center
City
Kerman
Province
Kerman
Postal code
7616913355
Phone
+98 34 3132 8000
Fax
+98 34 3132 8000
Email
nasirimajdfaranak@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Reza Malekpour Afshar
Street address
Kerman, the beginning of Haft Bagh Alavi axis, campus of University of Medical Sciences
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5700
Fax
+98 34 3132 5700
Email
r_malekpoor@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
Kerman University of Medical Sciences
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Toxicology
Street address
Kerman, the beginning of Haft Bagh Alavi axis, campus of University of Medical Sciences
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5700
Fax
+98 34 3132 5700
Email
nairimajdfaranak@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Faranak Nasiri Majd
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Toxicology
Street address
Kerman, the beginning of Haft Bagh Alavi axis, campus of University of Medical Sciences
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5700
Fax
+98 34 3132 5700
Email
nasirimajdfaranak@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Faranak Nasiri Majd
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Toxicology
Street address
Kerman, the beginning of Haft Bagh Alavi axis, campus of University of Medical Sciences
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5700
Fax
+98 34 3132 5700
Email
nasirimajdfaranak@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is 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
Yes - There is a plan to make this available
Title and more details about the data/document
Total data
When the data will become available and for how long
Starting from 6 months after the publication of the article
To whom data/document is available
Researchers, students and doctors
Under which criteria data/document could be used
To conduct a clinical trial
From where data/document is obtainable
General or scientific responsible person
What processes are involved for a request to access data/document
Send the proposal to the email of the person in charge