]>
IRCT20180103038199N6 IRCT 2021-06-10 Mashhad University of Medical Sciences The effect of saffron on mucositis Evaluation of the effectiveness of mucoadhesive mouthwash containing saffron petal extract on prevention and improvement of clinical symptoms of radiotherapy-induced oral mucositis 2024-11-21 anticipated 40 Recruiting https://irct.ir/trial/56281 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization takes place in three stages: 1- Creating a random sequence: in this stage of block randomization: quadruple blocks; Possible scenarios for two groups of experiment: Six quadruple modes including: 1- AABB, 2- ABAB, 3-BBAA, 4-BABA, 5-BAAB and 6- ABBA Possible scenarios for two groups of 20 equal to 10 = 4/40 Randomly write 10 blocks (using a table of random numbers) Write the final equivalent block Coding and allocating patients to receive medicine or placebo after opening the envelopes from number 1 to number 40, respectively. 2- Hide random allocation, which is done in the form of coded boxes with the random sequence with the help of random numbers table. In this method, a number of boxes of the same shape and size are numbered in random order and contain a medicine or placebo that have exactly the same regarding the appearance. 3- Execution of random allocation process: -The person who creates the random sequence: statistics consultant - The person who evaluates and registers the participants in terms of inclusion and exclusion criteria: Student of the project - The person who assigns the participants to the groups: Oncologist, Blinding description: Due to the use of placebo similar to the intervention treatment, the physician associated with the participants and participants will not be informed of the assigned treatment. Also, the analyst will be unaware of the treatment assigned to the two groups. Finally, after analyzing the data, the researcher who prepared the packages reveals codes A and B. The placebo will be very similar in treatment in terms of shape, consistency, packaging, and smell. 2-3 Radiotherapy-induced oral mucositis. Intervention 1: Control group: Receiving routine treatment (Acetaminophen 500 mg three times a day, Made by Jalinous company) + placebo mouthwash containing distilled water and glycerin twice a day made by Mashhad University of Medical Sciences. Intervention 2: Intervention group: Receiving routine treatment (Acetaminophen 500 mg three times a day, Made by Jalinous company) + Mouthwash containing 1% extract of saffron petals and distilled water and glycerin twice day made by Mashhad University of Medical Sciences. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no more information
public Dr Vahid Reza Askari
Faculty of Medicine, Azadi sq, Mashhad
Mashhad Iran (Islamic Republic of) 9177948564 +98 915 371 9688 askariv@mums.ac.ir Mashhad University of Medical Sciences scientific Dr Vahid Reza Askari
Faculty of Medicine, Azadi Sq, Mashhad
Mashhad Iran (Islamic Republic of) 9177948564 +98 915 371 9688 askariv@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Patients treated for head and neck cancer with chemo-radiotherapy Age between 18 and 70 years Absence of serious dental problems Absence of impacted teeth No cusp or sharp filling Total radiation is between 50 and 70 Gy during treatment Exposure of at least half of the oral cavity to radiation Patients should take one of the drugs cisplatin or 5-fluorouracil in their chemotherapy regimen. 18 years 70 years Both Severe infections that require antibiotics. Patients who have been allergic to any of the herbal extracts or previous radiotherapy Inability of the patient to implement the treatment protocol Renal failure (eGFR <50 ml / min) Liver failure (serum level 2 to 3 times higher than normal) K12.33 Oral mucositis (ulcerative) due to radiation Placebo Treatment - Drugs Control group: Receiving routine treatment (Acetaminophen 500 mg three times a day, Made by Jalinous company) + placebo mouthwash containing distilled water and glycerin twice a day made by Mashhad University of Medical Sciences Intervention group: Receiving routine treatment (Acetaminophen 500 mg three times a day, Made by Jalinous company) + Mouthwash containing 1% extract of saffron petals and distilled water and glycerin twice day made by Mashhad University of Medical Sciences Change in mucositis score based on World Health Organization scoring. Timepoint: Every week from the beginning of the drug (week zero) to the end of the study (week seven). Method of measurement: World Health Organization mucositis scoring questionnaire. Mashhad University of Medical Sciences Approved 2020-09-22 Ethics committee of Mashhad University of Medical Sciences Deputy of Research and Technology of the University, Qurashi Building, Next to Hoveyzeh Cinema, University Street Mashhad Razavi Khorasan Iran (Islamic Republic of)