The effects of chamomile and chlorine gel on oral mucositis caused by chemotherapy in children with cancer are compared.
Design
This study is an open label clinical trial, which is study phase 3, and block randomization method was used for randomization.
Settings and conduct
This study is an open label clinical trial. in which the participants were divided into two identical medicinal groups of Chamomile Tea and Clair Gel by means of block randomization. In each group, the corresponding treatment is performed. Finally, two groups are evaluated and compared in terms of severity of mucositis.
Participants/Inclusion and exclusion criteria
Conditions for inclusion in the study: children with cancer between 2 and 15 years of age who were admitted to the oncology department of Amirkabir Arak Hospital within 3 months؛ consent to participate in the study.
Conditions for not entering the study: history of drug allergy؛ presence of chronic mucocutaneous disease
Intervention groups
Chamomile tea group: Patients receive chamomile tea 6 times a day (every 4 hours) for 2 weeks.
Clair gel group: they receive Clear gel 4 times a day for 2 weeks.
Main outcome variables
The severity of mucositis
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191104045328N12
Registration date:2022-08-10, 1401/05/19
Registration timing:prospective
Last update:2022-08-10, 1401/05/19
Update count:0
Registration date
2022-08-10, 1401/05/19
Registrant information
Name
Amin Haji seyyed hoseini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3366 7583
Email address
amin.medstu@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-08-16, 1401/05/25
Expected recruitment end date
2022-12-16, 1401/09/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of chamomile and gelclair on chemotherapy-induced oral mucositis in children with cancer
Public title
Comparison of the effect of chamomile and gelclair on chemotherapy-induced oral mucositis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Children with cancer between the ages of 2 and 15 who were referred to the oncology department of Amirkabir Arak Hospital within 3 months
Consent to participate in the study
Exclusion criteria:
History of drugs allergy
Presence of chronic mucous skin disease
Age
From 2 years old to 15 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Participants are assigned to two intervention and control groups, respectively, based on the randomization sequence that will be generated beforehand. This sequence is unpredictable and its arrangement is completely random. Block randomization method with 8 blocks will be used to allocate samples. Thus, using block numerical random number generation software, a randomization sequence proportional to the sample size required for the two groups will be generated. Initially, all cases in which the two letters A and B can be arranged in blocks of 8 are produced. A block is then randomly selected from the blocks and the layout pattern in that block will be used to assign participants. This block will then be placed in the main container and another block will be selected again. All this will be done with software called Sealed Envelope. With this method, concealment will also be observed. The concept of concealment is to unpredictably assign individuals to groups. In fact, the researcher will not be able to predict which group the next person will be in.
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 Qom University of Medical Sciences
Street address
Qom, 15 Khordad Blvd., near Social Security Insurance, Islamic Azad University of Qom, Faculty of Medicine, Research Assistant
City
Arak
Province
Markazi
Postal code
3714668669
Approval date
2022-04-19, 1401/01/30
Ethics committee reference number
IR.IAU.QUM.REC.1401.026
Health conditions studied
1
Description of health condition studied
Oral mucositis
ICD-10 code
K12.3
ICD-10 code description
Oral mucositis (ulcerative)
Primary outcomes
1
Description
The severity of mucositis
Timepoint
1st, 7th and 14th day of treatment
Method of measurement
Physical examination
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients receive chamomile tea 6 times a day (every 4 hours) for 2 weeks.
Category
Treatment - Drugs
2
Description
Intervention group: they receive Clear gel 4 times a day for 2 weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Arak Amir Kabir Hospital
Full name of responsible person
Dr. Vahid Falahati
Street address
Vice Chancellor for Education, Amir Kabir Hospital, Arak, Iran
City
Arak
Province
Markazi
Postal code
3819691187
Phone
+98 86 3222 2003
Fax
+98 86 3222 2003
Email
vahidfalahati@arakmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr. Gholamreza Najafi
Street address
Qom, 15 Khordad Blvd., near Social Security Insurance, Islamic Azad University of Qom, Faculty of Medicine, Research Assistant
City
Arak
Province
Markazi
Postal code
3714668669
Phone
+98 25 3778 0001
Fax
+98 25 3778 0001
Email
qom@cms.iau.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
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
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Elham Ramezani
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Qom, 15 Khordad Blvd., near Social Security Insurance, Islamic Azad University of Qom, Faculty of Medicine, Research Assistant
City
Qum
Province
Ghoum
Postal code
3714668669
Phone
+98 25 3778 0001
Fax
+98 25 3778 0001
Email
Elham96261@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr. Vahid Falahati
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Hematology
Street address
Vice Chancellor for Education, Amir Kabir Hospital, Arak, Iran
City
Arak
Province
Markazi
Postal code
3819691187
Phone
+98 86 3222 2003
Fax
+98 86 3222 2003
Email
vahidfalahati@arakmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Sepideh Armanfar
Position
University student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
No. 7555, Taraj building, Zamangir alley 2, Ahmed Abadi alley, Jomhuri street, Mustafa Khomeini town, Arak
City
Arak
Province
Markazi
Postal code
3818137555
Phone
+98 86 3369 1282
Email
Armanfar.sepide@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
After conducting this study and analytical studies on it, only a part of the data such as information about the main outcome and patient demographic information will be published to the researchers who do the necessary correspondence with the person in charge of this study.
When the data will become available and for how long
Access will be from 2023/4/20 to 2026/4/20 for 3 years.
To whom data/document is available
University researchers
Under which criteria data/document could be used
Academic researchers or university professors or students who intend to use the data of this study, after obtaining permission from the relevant people mentioned, can use the information of this study in the field of metallurgical studies or other relevant review studies. In addition, if requested, they can use the information of this study for the prerequisites of their future studies and the existence of questions and ambiguities. Using the information of this study is subject to mentioning the names and logos of the responsible persons in this study.
From where data/document is obtainable
University researchers and university professors, after contacting the relevant professor by text message or e-mail, can request the use of data from Dr. Ramezani and then Dr. falahati, respectively. Dr. Elham Ramezani: Address: Qom, 15 Khordad Blvd., near Social Security Insurance, Islamic Azad University of Qom, Faculty of Medicine, Research Assistant. Postal Code: 3714668669 Phone: 09123519544 Email: Elham96261@gmail.com Dr. Vahid Falahati Address: Hospital Education Vice-Chancellor, Amirkabir Hospital, Arak Postal Code: 3814957558 Phone: 09133065573Email: vahidfalahati@arakmu.ac.ir
What processes are involved for a request to access data/document
Letter writing should be done with professors and universities.