IRCT20220607055099N1 IRCT 2023-07-19 Shahid Beheshti University of Medical Sciences Evaluaton of prophylactic effect of alpha lipoic acid on oral mucositis اثر پیشگیری کننده ALA روی RIOM Evaluaton of prophylactic effect of alpha lipoic acid on oral mucositis in patients undergoing head and neck radiotherapy 2023-07-21 anticipated 30 Complete https://irct.ir/trial/64029 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Other, Purpose: Supportive, Other design features: The main drug (alphalipoic acid) was given to the intervention group in this study. Placebo was assigned to the control group, Randomization description: Assignment of patients to two groups of 15 intervention (alpha-lipoic acid) and control group (methylcellulose) is based on six random blocks using Excel software. To obtain the number of samples according to SD1 = 0.13 and SD2 = 0.2 in the study of Kakoie et al. and with α = 0.05, B = 0.1 and power = 80% in order to detect a 0.2 difference between the two groups with a number of 15 samples in each We need a group. n=(Zα/2+Zβ)2×(SD1 +SD2)2/d2 The assignment of patients to the intervention and control groups is done by randomization, which was explained, so that the patients are not aware of the contents of the given capsule. Due to the similarity between the weight, color, and shape of the drugs, the possibility of informing the patients is minimized. The drugs are divided into two groups A and B by the supervisor, and the person who is in charge of the examination and delivery of the drugs and the follow-up of the patients at the same time (resident of oral, jaw and facial diseases) is unaware of the contents of A and B, Blinding description: This study is done in a double blind way. The assignment of patients to the intervention and control groups is done by randomization so that the patients are not aware of the contents of the given capsule. Due to the similarities between the weight, color, and shape of the drugs, the possibility of informing the patients is minimized. The drugs are divided into two groups A and B by the supervisor, and the person who is in charge of the examination and delivery of the drugs and the follow-up of the patients at the same time (resident of oral, jaw and facial diseases) is unaware of the contents of A and B. 3 Oral mucositis. Intervention group: alpha lipoic acid capsules 300 mg twice a day, 2 capsules each time during radiotherapy sessions to be consumed by the patients for two weeks afterwards. Alphalipoic acid (Raha Pharmaceutical Company): is one of the vitamin-like chemical substances that has an antioxidant function, in the sense that it destroys the toxic radicals created in the body.. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information.