A comparative study on the effect of mouthwash of licorice root extract with combination mouthwash on the incidence and severity of mucositis symptoms Caused by chemotherapy in colon cancer patients Admitted in the ICU
The application of anti-inflammatory effects of Licorice in the improvement of chemotherapy-induced mucositis symptoms
Design
Clinical trial with control and intervention group based on purpose, with parallel groups, blind and randomized trials
Settings and conduct
The study was available on a targeted basis and blinded by all patients with cancer in the ICU
Participants/Inclusion and exclusion criteria
Under periodic chemotherapy.
Mucositis
. People under colon cancer chemotherapy
(:)
Along with chemotherapy, they will also be radiotherapy
Transfer to another health facility
Intervention groups
Based on the criteria for entry, the patients were selected and randomly divided into control and intervention groups.
Main outcome variables
Mucositis
Severity of mucositis
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180109038281N1
Registration date:2018-04-12, 1397/01/23
Registration timing:registered_while_recruiting
Last update:2018-04-12, 1397/01/23
Update count:0
Registration date
2018-04-12, 1397/01/23
Registrant information
Name
amin sattari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3320 0627
Email address
criticalcare95@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-03-11, 1396/12/20
Expected recruitment end date
2018-06-10, 1397/03/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative study on the effect of mouthwash of licorice root extract with combination mouthwash on the incidence and severity of mucositis symptoms Caused by chemotherapy in colon cancer patients Admitted in the ICU
Public title
The effect of licorice in mucositis caused by chemotherapy
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Aged 18 years and older
Under periodic chemotherapy.
Mucositis
pationts undergoing full-fox cancer chemotherapy, which include (,Oxalipatin - Leucovorin , 5-fluorouracil) for at least one week in the hospital.
Not having asthma and other allergic diseases
Exclusion criteria:
Radiation therapy is also associated with chemotherapy.
Transfer to another health center.
Death during treatment.
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Data and Safety Monitoring Board
Sample size
Target sample size:
72
Randomization (investigator's opinion)
Randomized
Randomization description
Randomized block random block method with block size 6 (using a random permutation table).
Blinding (investigator's opinion)
Triple blinded
Blinding description
In this research, according to a randomized list, is assigned by a person outside the study according to the corresponding codes in the sealed envelopes, then assigned to any disease that is included in the study. Medications are identical in appearance, packaging, color, and so on. The nature of the drugs is revealed after the analysis of the results.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Ahvaz Jundishapur University of Medical Sciences
Street address
Building of Honey Plate 288, Street Tir-Dee and Bahman Blvd. Golestan
City
Ahvaz
Province
Khouzestan
Postal code
69816-41154
Approval date
2018-02-03, 1396/11/14
Ethics committee reference number
IR.AJUMS.REC.1396.942
Health conditions studied
1
Description of health condition studied
Mucositis
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Mucositis
Timepoint
At the beginning of the intervention, 3 and 7 days after the start of oral mucosal administration
Method of measurement
Oral Mucositis Assessment Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients receiving oral liquorice mouthwash at a concentration of 5%, 10 cc for one week and three times a day, are used as water soluble.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Baghaee Hospital 2- Intensive Care Unit
Full name of responsible person
Abdul Ali Shariati
Street address
Baghaee Hospital 2- Golestan Blvd.
City
Ahvaz
Province
Khouzestan
Postal code
6138933333
Phone
+98 61 3375 0425
Email
criticalcare95@gmail.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
aminsattari
Street address
Baghaee Hospital 2- Golestan Blvd.
City
Ahvaz
Province
Khouzestan
Postal code
6138933333
Phone
+98 61 3375 0425
Email
criticalcare95@gmail.com
Web page address
Grant name
Deputy of Research and Technology Development of Jundishapur University of Medical Sciences, Ahvaz
Grant code / Reference number
IR.AJUMS.REC.1396.942
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
aminsattari
Position
student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
No. 288- Honey Complex - Between Deh and Bahman - Golestan Avenue Blvd.
City
Ahvaz
Province
Khouzestan
Postal code
6136814158
Phone
+98 61 3320 0627
Email
criticalcare95@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
aminsattari
Position
student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery- Golestan Blvd.
City
Ahvaz
Province
Khouzestan
Postal code
6136814158
Phone
+98 61 3373 8070
Email
criticalcare95@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
amin sattari
Position
student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
No. 288- Honey Complex - Between Deh and Bahman - Golestan Avenue Blvd.
City
Ahvaz
Province
Khouzestan
Postal code
6136814158
Phone
+98 61 3320 0627
Email
criticalcare95@gmail.com
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