The goal of this clinical trial is the evaluation of effect of Morus nigra mouthwash on prevention and reduction of chemotherapy induced oral mucositis rate. This is a randomized double-blind and placebo-control study. 54 patients with Gastrointestinal cancer and under the chemotherapy regimen who are referred to Imam Khomeini hospital and Bagheban medical center in Sari are randomly placed in 2 groups of 27 people (intervention and control group). The first group of patients receive Morus nigra mouthwash three times a day each in the amount of 10 cc for two weeks.The second group receive placebo. All patients are visited at first and then at the end of the first week and the second by oral diseases speciallist and oral mucositis is recorded according to WHO indices.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017070234857N1
Registration date:2017-08-03, 1396/05/12
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-08-03, 1396/05/12
Registrant information
Name
Anahita Ghorbani
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 911 151 3085
Email address
aghorbani@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellar for research, Mazandaran University of Medical Sciences
Expected recruitment start date
2017-08-06, 1396/05/15
Expected recruitment end date
2017-09-21, 1396/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of Morus nigra mouthwash on chemotherapy induced oral mucositis
Public title
The effect of Morus nigra mouthwash on mucositis
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria :full awareness; oral mucosal health; non-autoimmune diseases; non-use of drugs; alcohol; cigarettes ; other oral mucus solutions during research and non-treatments such as radiation therapy.
exclusion criteria: Do not cooperate with the patient in using mouthwash
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
54
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Randomization of samples will take place through a random number table.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mazandaran University of Medical Sciences
Street address
Vice chancellor for research, the Shahid Motahari Square, Moalem Street
City
Sari
Postal code
-
Approval date
2017-07-09, 1396/04/18
Ethics committee reference number
IR.MAZUMS.REC.96.2979
Health conditions studied
1
Description of health condition studied
Chemotherapy-induced oral mucositis
ICD-10 code
K12.3
ICD-10 code description
Oral mucositis (ulcerative)
Primary outcomes
1
Description
severity of oral mucositis
Timepoint
Before the intervention, one week after the intervention, two weeks after the intervention
Method of measurement
WHO indices
Secondary outcomes
1
Description
-
Timepoint
-
Method of measurement
-
Intervention groups
1
Description
intervention gourp: administration of Morus nigra mouthwash, three times a day up two weeks, each time at 10 cc
Category
Treatment - Drugs
2
Description
Control group: receives placebo
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Zahra Ghasemzadeh
Street address
Amirmazandarani street, Sari
City
Sari
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Mazandaran University of Medical Sciences
Full name of responsible person
Ahmad Ali Enayati
Street address
Vice chancellor for research, the Shahid Motahari Square, Moalem Street
City
Sari
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Mazandaran University of Medical Sciences