Evaluation of efficacy of mouthwash and oral tablet of propolis on prevention and treatment of mucositis in hematopoietic stem cell transplantation recipients

The main purpose is to evaluate the effect of mouthwash and oral tablet of propolis in preventing mucositis, assessing the time and duration of mucositis, reducing the severity of mucositis and reducing infection (according to the results of microbial culture)

A randomized triple blind clinical trial with a parallel group design of 84 patients, who underwent autologous bone marrow transplantation

This study perform in the bone marrow transplant department of Ayatollah Taleghani Educational Hospital in a randomized, triple blind (patient, statistical analyzer and researcher) in two groups of drug and placebo

All patients hospitalized in bone marrow transplantation and patients undergoing chemotherapy. 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

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, 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

Incidence of mucositis; Duration of mucositis; Intensity of mucositis; The amount of narcotics analgesics needed; The amount of antibiotics needed

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.

In this study, participants, principle investigator initiated trials, data collectors, outcome assessors are unaware of the study groups.

Primary outcome data after making unrecognizable will be released

6 months after publishing the results primary outcome data will be released

Researchers after allowance of corresponding author could have the permission to have the data

Performing any analysis will be allowed only with the permission of corresponding author

Corresponding author

After requesting to reach data, corresponding author will check the allowance, then the researcher will be informed about it