]>
IRCT201309215704N2 IRCT 2014-04-12 Hematology and Oncology Research Center, Tabriz University of Medical Sciences, Iran Affect of Achillea millefolium in Prophylaxis of oral mucositis Affect of Achillea millefolium in Prophylaxis of oral mucositis induced by chemotherapy in AML patients. 2013-10-23 anticipated 18 Complete https://irct.ir/trial/6226 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention. N/A Oral mucositis. Intervention 1: 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. Intervention 2: 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.
public Simin Mashayekhi
Faculty of Pharmacy, Daneshgah St
Tabriz Iran (Islamic Republic of) +98 41 1339 2593 mashayekhis@tbzmed.ac.ir Tabriz University of Medical Sciences scientific Simin Mashayekhi
Faculty of Pharmacy, Daneshgah St
Tabriz Iran (Islamic Republic of) +98 41 1339 2593 mashayekhis@tbzmed.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) 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 16 years 85 years Both K12.3 Oral mucositis (ulcerative) Treatment - Drugs N/A 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. 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. Duration of mucositis. Timepoint: From begining of chemotherapy until 21 days later. Method of measurement: Counting number of days. Severity of mucositis. Timepoint: First day of chemotherapy until 21 days later. Method of measurement: WHO oral mucositis scale. 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. Hematology and Oncology Research Center, Tabriz University of Medical Sciences, Iran Approved 2013-12-02 ٍEthics Committee of Tabriz University of medical Sciences Daneshgah St, 2nd main Building, Vice Chancellor for research, Tabriz University of Medical Science Tabriz Iran (Islamic Republic of)