The effect of Aloe vera mouthwashe on the intensity of stomatitis and related pain in all patients with leukemia and lymphoma who receiving chemotherapy refferd to hospitals affiliated to Shiraz University of Medical Science.
Study objective: The main objective of the project:The effect of Aloe vera mouthwashe on the intensity of stomatitis and related pain in patients with leukemia and lymphoma who receiving chemotherapy refferd to hospitals affiliated to Shiraz University of Medical Science- Design of study: randomized,single blind,controlled- study population: All patients with lymphoma and lukemia refferd to the hospitals affiliated to Shiraz University of Medical Science. main inclusion criteria: Willingness to participate in the study; Minimum age of 18 years; New diagnosed cancer with AML and ALL; Absence of underlying disease; No addiction to cigar,tobacco; The lack of context sensitivity on aloe vera. Main exclusion criteria: food allergy to the substances during the study; A ciritical condition during the study that causes patients exclusion. sample size: 64 people- study Intervention: patients will divided into two groups based on the list of random numbers. in the intervention group patients will use 5cc aleo vera 3 time daily. controls patiens will use only prescribed mouthwashes. To investigate the effects of drugs on the degree of mucositis, the table provided by the World Health Organization (WHO) will be used. Expected recruitment start date:23/8/2014- Expected recruitment end date: 23/10/2014- Study primary outcome: stomatitis grade and related pain.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014092819318N1
Registration date:2014-11-02, 1393/08/11
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-11-02, 1393/08/11
Registrant information
Name
Maryam Haghighi
Name of organization / entity
Shiraz University of Medical Science and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 32297527
Email address
haghighi_ma@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Science and Health Services
Expected recruitment start date
2014-08-23, 1393/06/01
Expected recruitment end date
2014-10-23, 1393/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Aloe vera mouthwashe on the intensity of stomatitis and related pain in all patients with leukemia and lymphoma who receiving chemotherapy refferd to hospitals affiliated to Shiraz University of Medical Science.
Public title
Effect of aloe vera on chemotherapy induced stomatitis
Purpose
Supportive
Inclusion/Exclusion criteria
Main inclusion criteria: Willingness to participate in the study; Minimum age of 18 years; New diagnosed cancer with AML and ALL; Absence of underlying disease; No addiction to cigar,tobacco; The lack of context sensitivity on aloe vera. Main exclusion criteria: food allergy to the substances during the study; A ciritical condition during the study that causes patients exclusion.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
shiraz university of medical science and health services
Street address
shiraz, zand blv, central building of shiraz university of medical science
City
shiraz
Postal code
71345-1978
Approval date
2014-08-04, 1393/05/13
Ethics committee reference number
CT-9374-7114
Health conditions studied
1
Description of health condition studied
AML
ICD-10 code
c92
ICD-10 code description
Acute Myeloblastic Leukaemia
2
Description of health condition studied
ALL
ICD-10 code
C91
ICD-10 code description
Acute Lymphoblastic Leukaemia
Primary outcomes
1
Description
intensity of stomatitis
Timepoint
5 visit in 2 weeks, in 1th, 3th,5th,7th,14th days
Method of measurement
stomatitis scale provided by WHO
2
Description
stomatitis related pain
Timepoint
2 weeks, 5 visit in 1th,3th,5th,7th,14th days
Method of measurement
VAS
Secondary outcomes
empty
Intervention groups
1
Description
interventional group: prescription of aloe vera mouthwashe. for 2 weeks and 3 time daily, using 5 cc of aloevera mouthwashe each time.
Category
Treatment - Drugs
2
Description
patient will used commonly prescribed mouthwashes in hemathology and oncology departments for 2 weeks and 3 times/ day 5 cc each times.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Namazi Hospital
Full name of responsible person
Dr Mani Ramzi, Oncologist
Street address
Namazi Hospital, Namazi square, shiraz
City
Shiraz
2
Recruitment center
Name of recruitment center
Shaheed Motahari Clinic
Full name of responsible person
Dr Mani Ramzi, Oncologist
Street address
Fourth floor, Shaheed Motahari Clinic, Shiraz
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Science and Health Services
Full name of responsible person
Dr Seyed Basir Hashemi
Street address
Research Deputy, Central building of Shiraz University of Medical Science, Blv Zand
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Science and Health Services
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
School of Nursing-Midwifery Fatemem
Full name of responsible person
MA Parisa Mansoori
Position
Master of Nursing/ Nursing Mentor
Other areas of specialty/work
Street address
School of Nursing-Midwifery Fatemem, Namazi Square.
City
Shiraz
Postal code
Phone
+98 71 3647 4254
Fax
Email
mansoorip@sums,ac,ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Science
Full name of responsible person
Dr Mani Ramzi
Position
Oncologist
Other areas of specialty/work
Street address
Department of bone marrow transplantation, Namazi hospital
City
Shiraz
Postal code
Phone
+98 71 3647 4301
Fax
Email
ramzim@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Science
Full name of responsible person
Maryam Haghighi
Position
Master of nursing student
Other areas of specialty/work
Street address
Shahab building, Khakshenasi 9
City
Shiraz
Postal code
Phone
00
Fax
Email
hgh_maryam@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)