Purpose of study: Evaluating the effect of herbal mouthwash on preventing and treatment of oral mucositis in patients undergoing hematopoietic stem cell transplantation. Study design: triple blind, randomized, placebo controlled trial with a single recruitment center. Main inclusion criteria: All patients in Bone Marrow Transplant Center undergoing conditioning therapy. Main exclusion criteria: The patients who don’t want to continue the study or allergic reactions like hives, swollen lips and inflammation of the oral mucosa caused by plants used to make the herbal mouthwash. Sample size: 60 patients. Intervention: Using herbal or placebo mouthwash 3 times daily. Intervention time: From stem cell collection day till WBC Engraftment time. Outcomes: Pain, erythema, swallowing ability and ulcer using European Bone Marrow Transplantion qustionnaire, WBC Engraftment time and Platelet Engraftment time based on patient's analysis result.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201105183210N3
Registration date:2011-10-16, 1390/07/24
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-10-16, 1390/07/24
Registrant information
Name
Maria Tavakoli Ardakani
Name of organization / entity
Faculty of pharmacy, Shaid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8887 3704
Email address
mariatavakoli@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research of Faculty of Pharmacy of Shahid Beheshti University
Expected recruitment start date
2011-10-08, 1390/07/16
Expected recruitment end date
2012-10-07, 1391/07/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effect of herbal mouthwash on preventing and treatment of oral mucositis in patients undergoing hematopoietic stem cell transplantation
Public title
Evaluating the effect of herbal mouthwash on preventing and treatment of oral mucositis in patients undergoing hematopoietic stem cell transplantation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: All patients in Bone Marrow Transplant Center undergoing conditioning therapy. Exclusion criteria: The patients who don’t want to continue the study, Allergic reactions like hives, swollen lips and inflammation of the oral mucosa caused by plants used to prepare the herbal mouthwash.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
Shahid Beheshti University of Medical Sciences, Velenjak street
City
Tehran
Postal code
Approval date
2011-10-02, 1390/07/10
Ethics committee reference number
106
Health conditions studied
1
Description of health condition studied
oral mucositis
ICD-10 code
K12
ICD-10 code description
Stomatitis and related lesions
Primary outcomes
1
Description
Pain
Timepoint
After intervention, daily
Method of measurement
Visual pain scale
2
Description
Ulcer
Timepoint
After intevention, daily
Method of measurement
EBMT qustionnaire
3
Description
Erythema
Timepoint
after intervention, daily
Method of measurement
EBMT questionnaire
4
Description
Swallowing ability
Timepoint
after intervention, daily
Method of measurement
EBMT questionnaire
5
Description
WBC Engraftment Time
Timepoint
At the end of the intervention
Method of measurement
Blood test
6
Description
Platelet Engraftment Time
Timepoint
At the end of the intervention
Method of measurement
Blood test
Secondary outcomes
1
Description
Allergic reactions
Timepoint
After intervention, daily
Method of measurement
Outbreak of hives, swollen lips and inflammation of the oral mucosa
Intervention groups
1
Description
Intervention group: treatment patients receive herbal mouthwash. patients should gargle it 3 times daily, every time diluting 1 milliliter of mouthwash in 50 milliliters water, during the time of their hospitalization (about 20 days)
Category
Treatment - Drugs
2
Description
Control group: placebo patients receive placebo mouthwash. patients should gargle it 3 times daily, every time diluting 1 milliliter of mouthwash in 50 milliliters water, during the time of their hospitalization (about 20 days)
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Taleghani hospital
Full name of responsible person
Dr. Maria Tavakoli Ardakani
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research of Faculty of Pharmacy of Shahid Beheshti University of Medical Science
Full name of responsible person
Dr. Afshin Zarghi
Street address
Faculty of Pharmacy, Valiasr street, Nyayesh Junction
City
Tehran
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 of Faculty of Pharmacy of Shahid Beheshti University of Medical Science
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Faculty of Pharmacy, Shahid Beheshti University Of Medical Sciences
Full name of responsible person
Sara Ghasemi
Position
Student of Pharm.D
Other areas of specialty/work
Street address
Faculty of Pharmacy, Valiasr street, Nyayesh Junction
City
Tehran
Postal code
14155-6153
Phone
+98 21 2270 8987
Fax
Email
sara_ghasemi64@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Faculty of Pharmacy, Shahid Behesti University of Medical Sciences
Full name of responsible person
Dr Maria Tavakoli Ardakani
Position
clinical pharmacy specialist
Other areas of specialty/work
Street address
Faculty of Pharmacy, Valiasr street, Nyayesh Junction
City
Tehran
Postal code
Phone
+98 2188200118256
Fax
Email
mariatavakoli@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Faculty Of Pharmacy, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Sara Ghasemi
Position
Student of Pharm.D
Other areas of specialty/work
Street address
Faculty of Pharmacy, Valiasr street, Nyayesh Junction
City
Tehran
Postal code
Phone
+98 21 2270 8987
Fax
Email
sara_ghasemi64@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)