Aim of this research is to study prophylactic effect of Achillea millefolium extract on oral mucositis in AML patients. This randomized study is performed in Shahid Ghazi hospital in Tabriz. Cases are chosen from AML male or female patients aged 16 to 85 who are candidate for chemotherapy. Pregnant patients and those who are not volunteer or have less than 3 weeks of hospitalization and patients with existence mucositis will be excluded. 18 patients will be chosen randomly and they will be divided to two groups by random allocation. Intervention group will received 10 to 15 ml of Achillea mouthwash twice daily in addition towards normal treatments(chlorhexidine mouthwash). The other group will receive routine regimen(control group). Clinical signs and quality of life of patients will be recorded a form. CBC will be measured. Patients' oral mucositis will be graded by WHO mucositis scale. Amount of analgesics consumed, duration and severity of mucositis will be register on day1 until day 21 of chemotherapy.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201309215704N2
Registration date:2014-04-12, 1393/01/23
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-04-12, 1393/01/23
Registrant information
Name
Simin Ozar Mashayekhi
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1337 2250
Email address
mashayekhis@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Hematology and Oncology Research Center, Tabriz University of Medical Sciences, Iran
Expected recruitment start date
2013-10-23, 1392/08/01
Expected recruitment end date
2014-06-05, 1393/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Affect of Achillea millefolium in Prophylaxis of oral mucositis induced by chemotherapy in AML patients.
Public title
Affect of Achillea millefolium in Prophylaxis of oral mucositis
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: AML patients including both male or female ones, aged between 16-85 who are candidate for chemotherapy;
Exclusion criteria: Pregnancy; Patients who are not volunteer; Patients with less than 3 weeks duration of hospitalization; Patients with mucositis
Age
From 16 years old to 85 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
18
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
ٍEthics Committee of Tabriz University of medical Sciences
Street address
Daneshgah St, 2nd main Building, Vice Chancellor for research, Tabriz University of Medical Science
City
Tabriz
Postal code
51664-14766
Approval date
2013-12-02, 1392/09/11
Ethics committee reference number
92144
Health conditions studied
1
Description of health condition studied
Oral mucositis
ICD-10 code
K12.3
ICD-10 code description
Oral mucositis (ulcerative)
Primary outcomes
1
Description
Duration of mucositis
Timepoint
From begining of chemotherapy until 21 days later
Method of measurement
Counting number of days
2
Description
Severity of mucositis
Timepoint
First day of chemotherapy until 21 days later
Method of measurement
WHO oral mucositis scale
Secondary outcomes
1
Description
Amount of analgesics requested for pain caused by mouth sores
Timepoint
First day of chemotherapy until 21 days later
Method of measurement
Type and dosage of analgesics recorded in patients records in 21 days duration
Intervention groups
1
Description
Intervention group will receive hospital's routine prophylactic therapy, which is cholorhexidine mouthwash, and Achillea's extract mouthwash. After preparation of Achillea's extraction, it is used for preparation of mouthwash formulation, which will be used 10 to 15 ml twice daily. Achillea and cholorhexidine mouthwash will be used in different times of day. Patients will be asked not to eat, drink or wash their mouth for 1.5 hours after using mouthwash. During 21 days, presence of mucositis, its duration, severity and type and dose of used analgesics will be recorded.
Category
Treatment - Drugs
2
Description
Control group will receive hospital's routine prophylactic therapy, which is cholorhexidine mouthwash. 5 ml Cholorhexidine mouthwash will be used once daily. Patients will be asked not to eat, drink or wash their mouth for 1.5 hours after using mouthwash. During 21 days, presence of mucositis, its duration, severity and type and dose of used analgesics will be recorded.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Ghazi hospital Tabriz
Full name of responsible person
Dr Simin Mashayekhi,PhD, Assistant professor
Street address
Faculty of Pharmacy, Daneshgah St,
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hematology and Oncology Research Center, Tabriz University of Medical Sciences, Iran
Full name of responsible person
Mohammadreza Rashidi
Street address
Vice Chancellor for research,Tabriz University of Medical Science, 2nd main Building, Daneshgah St.
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hematology and Oncology Research Center, Tabriz University of Medical Sciences, Iran
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
Tabriz University of Medical Sciences
Full name of responsible person
Simin Mashayekhi
Position
PhD, Assistant professor
Other areas of specialty/work
Street address
Faculty of Pharmacy, Daneshgah St
City
Tabriz
Postal code
Phone
+98 41 1339 2593
Fax
Email
mashayekhis@tbzmed.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Simin Mashayekhi
Position
PhD, Assistant professor
Other areas of specialty/work
Street address
Faculty of Pharmacy, Daneshgah St
City
Tabriz
Postal code
Phone
+98 41 1339 2593
Fax
Email
mashayekhis@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Simin Mashayekhi
Position
PhD, Assistant professor
Other areas of specialty/work
Street address
Faculty of Pharmacy, Daneshgah St
City
Tabriz
Postal code
Phone
+98 41 1339 2593
Fax
Email
mashayekhis@tbzmed.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)