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IRCT20180416039318N2 IRCT 2018-05-23 Mashhad University of Medical Sciences Assessing the preventing and therapeutic effect of curcumin mucositis Assessing the preventing and therapeutic effect of curcumin in radiotherapy-induced mucositis of head and neck cancers 2018-04-27 anticipated 40 Complete https://irct.ir/trial/30795 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients are randomly divided into two groups, namely the Study and Control groups. Randomization is performed using a computer-generated random number table, Blinding description: In this study, since the apparent appearance of the drugs is not the same, curcumin and placebo are prepared and coded by the clinical pharmacologist in the same pharmaceutical package and code decoding takes place during statistical analysis.The prepared medicine packs are the same for the two group. Packages are randomly delivered to patients. The participants and care providers and assessing outcomes and the statistician are blinded to type of drug. 3 oral mucositis. Intervention 1: Intervention group:80 mg/d oral curcumin (1 capsule of SinaCurcumin® 80 per day), during radiotherapy (6 weeks). Each soft gel of SinaCurcumin® contains 80 mg of curcumin in the form of nano-micelle. Intervention 2: Control group: placebo tablets (containing lactose) once daily during radiotheraoy. prepared by a pharmacologist colleague. Yes - There is a plan to make this available What will be shared: Some data including demographic properties, signs and symptoms When: Two months after article publication. To whom: Academic researchers Conditions: It is permitted to use the data in other studies with reference. Where to obtain: Dr Ala Ghazi e-mail: ghazial@mums.ac.ir How to obtain: Sending email to authors. the authors will send data via email during 4 weeks Comments:
public Ala Ghazi
Mashhad Dental School, Azadi Square, Vakilabad Blvd
Mashhad Iran (Islamic Republic of) 9177948959 +98 51 3882 9501 ghazial@mums.ac.ir Mashhad University of Medical Sciences scientific Zahra Delavarian
Mashhad Dental School, Azadi Square, Vakilabad Blvd
Mashhad Iran (Islamic Republic of) 9177948959 +98 51 3882 9501 delavarianz@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria were the following: minimum age of 18 years, presence of head and neck cancer, radiationtherapy of 50 Gy or greater, at least 50% of patient’s oral cavity in the field of radiation, and willing to be a part of the study and sign the informed consent.. 18 years no limit Both Exclusion criteria were the following: the history of previous radiation therapy or chemotherapy, chemotherapy protocol in addition to radiotherapy, any allergy to condiments, especially “Turmeric root”, having a pre-existing oral disease such as an active oral infection or an oral ulceration. k12 Stomatitis and related lesions Treatment - Drugs Placebo Intervention group:80 mg/d oral curcumin (1 capsule of SinaCurcumin® 80 per day), during radiotherapy (6 weeks). Each soft gel of SinaCurcumin® contains 80 mg of curcumin in the form of nano-micelle. Control group: placebo tablets (containing lactose) once daily during radiotheraoy. prepared by a pharmacologist colleague The effect of curcumin on severity of mucositis. Timepoint: Before the initiation of radiotherapy and then on days 7, 14, 21, 28, 35 and 42 of the radiotherapy course. Method of measurement: the National Cancer Institute Common Toxicity Criteria version 2 scale (NCI CTC v.2). The effect of curcumin on the onset of mucositis. Timepoint: Before the initiation of radiotherapy and then on days 7, 14, 21, 28, 35 and 42 of the radiotherapy course. Method of measurement: the National Cancer Institute Common Toxicity Criteria version 2 scale (NCI CTC v.2). Mashhad University of Medical Sciences Approved 2014-07-12 دانشگاه علوم پزشکی مشهد- کمیته دانشکده ای اخلاق در پژوهشهای انسانی Mashhad Dental School, Azadi Square, Vakilabad Blvd Mashhad Razavi Khorasan Iran (Islamic Republic of)