Patients in three groups receiving curcumin 0.1% mouthwash or curcumin capsule 40 mg or placebo mouthwash will be randomly divided into reciprocating blocks (each group of 20 people) and each patient will use mouthwashes belonging to their group 3 times a day or 40 mg capsule daily for 3 weeks. Patients will not use other therapies during this time. This is a prospective single blind randomized controlled clinical trial and will be performed on 30 patients who accidentally enter three groups of 20 people to control or interventions.
Settings and conduct
Patients admitted to the study will be selected from the patients of the Shahid Ramezanzadeh Radiation Therapy Center in Yazd will enter the study randomly.
Participants/Inclusion and exclusion criteria
Patients aged 18 to 65 years old with mucositis caused by receiving at least a dose of 50 gray of radiation during total radiotherapy and involvement of at least two parts of the mouth.
Intervention groups
Intervention group1: patients will be received 0.1% curcumin mouthwash 3 times a day for 3 weeks
Intervention group 2: patients will be received curcumin capsule 40 mg per day for 3
Control group: patients will be received placebo mouthwash 3 times a day for 3 weeks
Main outcome variables
Wounds - redness - pain and burning - severity and frequency
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190810044500N17
Registration date:2021-08-13, 1400/05/22
Registration timing:prospective
Last update:2021-08-13, 1400/05/22
Update count:0
Registration date
2021-08-13, 1400/05/22
Registrant information
Name
Fatemeh Saghafi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3820 3419
Email address
f.saghafi@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-08-23, 1400/06/01
Expected recruitment end date
2021-12-22, 1400/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of curcumin on radiation induced mucositis
Public title
Effect of curcumin on radiation induced mucositis
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with mucositis caused by radiotherapy and chemotherapy
Get at least a dose of 50 gray of radiation during the study
At least two parts of the mouth are involved
Exclusion criteria:
Patients with certain diseases
Unwillingness to continue participating in the study
smoking
Serious dental problems, bruising teeth and the presence of sharp fillings
Presence of artificial teeth importing trauma
Severe systemic disease such as uncontrolled diabetes
With the start of radiation therapy, the patient should be treated by a physician other than for the usual treatment for mucositis.
Simultaneous treatment with Target therapy drugs
Infection
Age
From 18 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
45
Randomization (investigator's opinion)
Randomized
Randomization description
Patients were randomly assigned to three groups of 20 curcumin mouthwash, curcumin tablets, and placebo by the permuted block method. Treatment assignments within blocks are determined so that they are random in order but that the desired allocation proportions are achieved exactly within each block.
12 blocks of 5 are considered. Generation of random codes using Permuted Block Randomization method will be done with the help of Random allocation software (version 1). The first person who is eligible to enter the study is given number one and likewise, the last eligible person is given number 60. By using the software-generated table, patients receive each intervention (A or B or C). In order to consider blinding in random allocation, the list is given to another person outside the study and using short message service (SMS) before assigning the type of treatment according to the number of eligible people is asked and thus people enter the study.
Blinding (investigator's opinion)
Single blinded
Blinding description
The steps will be covered by the assessor. The first presenter identifies the sequence of assignments of patients according to the order of entry of the patients into the study and identifies them with A or B or C codes. The student then delivers the drugs to each individual patient
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Insitutional research Ethics Committee School of Medicine, Shahid Sadoughi University of Medical Sci
Street address
Shahid Sadoughi University of Medical Sciences, Shohaday Gomnam blvd.
City
Yazd
Province
Yazd
Postal code
8915173143
Approval date
2020-09-13, 1399/06/23
Ethics committee reference number
IR.SSU.MEDICINE.REC.1399.112
Health conditions studied
1
Description of health condition studied
Mucositis
ICD-10 code
K12. 30
ICD-10 code description
Diseases of the digestive system
Primary outcomes
1
Description
Oral wound size
Timepoint
Before the intervention, after completion of the intervention
Method of measurement
Clinical examination
Secondary outcomes
1
Description
Pain or burning sensation in the mouth
Timepoint
Before intervention, after intervention
Method of measurement
Clinical examination and patient based on VAS criteria
2
Description
Redness
Timepoint
Before intervention, after intervention
Method of measurement
Clinical examination and patient based on VAS criteria
Intervention groups
1
Description
Intervention group1: patients will be received 0.1% curcumin mouthwash 3 times a day for 3 weeks
Category
Treatment - Drugs
2
Description
Intervention group 2: patients will be received curcumin capsule 40 mg per day for 3 weeks
Category
Treatment - Drugs
3
Description
Control group: patients will be received placebo mouthwash 3 times a day for 3 weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Ramazanzadeh Radiation Therapy Center in Yazd
Full name of responsible person
Shiva Ghadirian
Street address
Shahid Motahari Street
City
yazd
Province
Yazd
Postal code
8917885976
Phone
+98 35 3822 9801
Email
shiva_gh_73@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Masoud Mirzaei
Street address
Shahid Sadoughi University of Medical Sciences, Bahonar Ave.
City
Yazd
Province
Yazd
Postal code
9856783459
Phone
+98 35 3146 2056
Email
mmirzaei@ssu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd University of Medical Sciences
Proportion provided by this source
20
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
Yazd University of Medical Sciences
Full name of responsible person
shiva ghadirian abarghoyi
Position
University student
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
Shahid Sadoughi Medical Sciences Campus, Professor Hesabi Blvd.
City
yazd
Province
Yazd
Postal code
8917885976
Phone
+98 35 3822 9801
Email
shiva_gh_73@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Fateme Saghafi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Shahid Sadoughi University of Medical Sciences, Shohaday Gomnam blvd.
City
Yazd
Province
Yazd
Postal code
8915173143
Phone
+98 35 3820 3419
Email
Saghfi.Fa@gmail.comhs
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Shiva Ghadirian
Position
University student
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
Shahid Sadoughi Medical Sciences Campus, Professor Hesabi Blvd.
City
Yazd
Province
Yazd
Postal code
8914885976
Phone
+98 35 3822 9801
Email
shiva_gh_73@yahoo.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