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IRCT20100127003210N24 IRCT 2021-11-11 Shahid Beheshti University of Medical Sciences Efficacy and safety of mouthwash and oral tablet of propolis on the mucositis in hematopoietic stem cell transplantation recipients Evaluation of efficacy of mouthwash and oral tablet of propolis on prevention and treatment of mucositis in hematopoietic stem cell transplantation recipients 2021-11-15 anticipated 84 Complete https://irct.ir/trial/54956 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, the randomization method is permuted block technique randomization and the randomization unit is cluster. The allocation and distribution of blocks is done with the help of random allocation software and each person is assigned a code created with the help of software. In fact, we have two groups of 42 patients, one receiving medication and one receiving placebo. Each group also has 6 blocks, which are transplant type blocks, including autologous and allogeneic transplants, and age blocks, including patients aged 20 to 40 years, 40 to 60 years, and over 60 years. Each block contains 7 people. The variables of blocks include the age of patients and their type of transplantation, so that patients are divided into two groups of 42 people based on age and type of transplantation, each group consists of 6 blocks of 7 people, Blinding description: In this study, participants, principle investigator initiated trials, data collectors, outcome assessors are unaware of the study groups. 2-3 Condition 1: Oral mucositis. Condition 2: Gastrointestinal mucositis. Intervention 1: Intervention group: receiving propolis, in amounts of 7.5 ml, from the mouthwash form, every 12 hours, for 15 days and one tablet, from the oral form, every 8 hours, for 10 days, along with receiving standard mucositis treatment, from the first day of chemotherapy until engraftment. Intervention 2: Control group: receiving placebo (including neutral and permitted additives with similar characteristics to mouthwash and oral propolis tablets), in amounts of 7.5 ml, from the mouthwash form, every 12 hours, for 15 days and one tablet, from the oral form, every 8 hours, for 10 days, along with receiving standard mucositis treatment, from the first day of chemotherapy until engraftment. Yes - There is a plan to make this available What will be shared: Primary outcome data after making unrecognizable will be released When: 6 months after publishing the results primary outcome data will be released To whom: Researchers after allowance of corresponding author could have the permission to have the data Conditions: Performing any analysis will be allowed only with the permission of corresponding author Where to obtain: Corresponding author How to obtain: After requesting to reach data, corresponding author will check the allowance, then the researcher will be informed about it Comments:
public Mahsa Khanzadeh
Faculty of Pharmacy, Shahid Beheshti University of Medical Science, Valiasr St., Hashemi Rafsanjani Highway intersection., Tehran, Iran.
Tehran Iran (Islamic Republic of) 1991953381 +98 21 8820 0118 Khnzd1996@gmail.com Shahid Beheshti University of Medical Sciences scientific Maria Tavakoli Ardakani
Faculty of Pharmacy, Shahid Beheshti University of Medical Science, Valiasr St., Hashemi Rafsanjani Highway intersection., Tehran, Iran.
Tehran Iran (Islamic Republic of) 1991953381 +98 21 8820 0085 Mariatavakoli@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) All patients hospitalized in bone marrow transplantation who received conditioning chemotherapy regimen Patient satisfaction and cooperation to participate in the study Ability to communicate and answering questions during the period of mucositis Patients from previous chemotherapy or radiotherapy should not have oral mucositis and should be included in the study from the beginning of treatment 18 years 70 years Both History of allergies to propolis or other components of mouthwash and oral tablet History of asthma, seasonal allergies and history of aspirin allergy Taking anticoagulant drugs such as warfarin Fasting blood sugar above 150 mg/dl K12.31 K92.81 Oral mucositis (ulcerative) due to antineoplastic therapy Gastrointestinal mucositis (ulcerative) Treatment - Drugs Placebo Intervention group: receiving propolis, in amounts of 7.5 ml, from the mouthwash form, every 12 hours, for 15 days and one tablet, from the oral form, every 8 hours, for 10 days, along with receiving standard mucositis treatment, from the first day of chemotherapy until engraftment Control group: receiving placebo (including neutral and permitted additives with similar characteristics to mouthwash and oral propolis tablets), in amounts of 7.5 ml, from the mouthwash form, every 12 hours, for 15 days and one tablet, from the oral form, every 8 hours, for 10 days, along with receiving standard mucositis treatment, from the first day of chemotherapy until engraftment Mucositis. Timepoint: First day of chemotherapy until engraftment day. Method of measurement: WHO scoring system. Fever grade. Timepoint: From the first day of chemotherapy until engraftment time. Method of measurement: Submit a fever above 38.3 °C for patients. The need for total parenteral nutrition (TPN). Timepoint: During the study period. Method of measurement: Sign the days of parenteral nutrition intake. The amount of narcotics analgesics needed. Timepoint: Daily. Method of measurement: Patient's medication list. The amount of antibiotics needed. Timepoint: Daily. Method of measurement: Patient's medication list. Shahid Beheshti University of Medical Sciences Approved 2021-03-13 Ethics committee of Faculty of Pharmacy - Shahid Beheshti University of Medical Sciences Faculty of Pharmacy, Shahid Beheshti University of Medical Science, Valiasr St., Hashemi Rafsanjani Highway intersection., Tehran, Iran. Tehran Tehran Iran (Islamic Republic of)