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IRCT20180416039318N3 IRCT 2018-06-02 Mashhad University of Medical Sciences Assessing the effect of nanomisel curcumin on prevention and treatment of nanomisel curcumin Evaluation of the efficacy of nanomisel curcumin in preventing and treating oral candidiasis of patients undergoing head and neck radiation therapy 2018-05-22 anticipated 40 Complete https://irct.ir/trial/31079 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, 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, the prepared medicine packs are the same for the two groups. Packages are coded from 1 to 40 by an individual outside the study. Packages are randomly delivered to patients. The participants and care providers and assessing outcomes and statistician are blinded to type of drug. 2-3 Oral Candidiasis. Intervention 1: Intervention group: nanocurcumin soft gel (containing 80 mg curcumin) are administrated orally once daily. Intervention 2: Control group: The control group: placebo tablets are administrated orally once daily. 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.Sedigheh Modarres Mousavy, ModarresMS921@mums.ac.ir How to obtain: Sending email to authors. the authors will send data via email during 4 weeks Comments:
public Sedigheh Modarres Mousavy
Mashhad Dental School, Azadi Square, Vakilabad Blvd
Mashhad Iran (Islamic Republic of) 9177948959 +98 51 3882 9501 ModarresMS921@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) the minimum age of 18 years, presence of head and neck cancer, radiation dose of 50-70 Gy, at least 50% of patient’s oral cavity in the field of radiation and patient satisfaction. 18 years no limit Both previous history of radiation therapy, patient dissatisfaction, history of allergy to turmeric, , in case of any oral lesions or complication resulting from radiation therapy other than candidiasis and mucositis, use of systemic or topical antifungal drugs for any reason, pregnancy or breastfeeding periods in women under treatment, presence of local and systemic conditions predisposing for candidiasis, such as the application of inhaled and topical steroids, presence of hyperkeratosis, use of immunosuppressive drugs, history of systemic antibiotic usage over the previous 2 weeks, the presence of CFU above 400/ml in the first culture or clinical evidence based on the presence of oral candidiasis. B 37.0 Candidal stomatitis/Oral thrush Treatment - Drugs Placebo Intervention group: nanocurcumin soft gel (containing 80 mg curcumin) are administrated orally once daily. Control group: The control group: placebo tablets are administrated orally once daily. Ccurrence of oral candidiasis. Timepoint: The first day of radiotherapy before radiation, every week until the end of the study. Method of measurement: Clinical examinations of oral lesion. Candidate colony count in ml (colony forming unit = CFU). Timepoint: before the study, in the third week and the final week of radiotherapy. Method of measurement: Cultivation of oral lesions. Type of oral Candidiasis. Timepoint: before the study, in the third week and the final week of radiotherapy. Method of measurement: germ tube test and cultivation of oral lesions. Mashhad University of Medical Sciences Approved 2015-09-09 Ethics committee of Mashhad University of Medical Sciences Mashhad Dental School, Azadi Square, Vakilabad Blvd Mashhad Razavi Khorasan Iran (Islamic Republic of)