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IRCT20161024030475N4 IRCT 2019-07-21 Tehran University of Medical Sciences effect of propolis on oral mucositis resulting from radiotherapy Evaluating and comparing the effect of systemic and local use of Propolis in oral mucositis resulting from radiotherapy 2015-08-23 anticipated 72 Complete https://irct.ir/trial/38070 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization method: Simple randomization, Randomization Unit: individual, Randomization tool: random number table. There is not allocation concealment, Blinding description: the producing company were asked to produce the propolis pills and placebo pill with the same apperance. Propolis and placebo mouthwash were also produced with the same color and in the same bottels. the drugs were divided into 3 seperate groups. one contianing placebo pills and propolis mouthwash, one contianing placebo mouthwash and propolis pills and the other one containing placebo pills and mouthwash. on each bottel nomber 1, 2 or 3 were written. in a sealed letter the content of each group were revealed. patients , researcher and statistic expert were blinded. 3 Oral mucositis (ulcerative) due to radiation. Intervention 1: Intervention group: local propolis and systemic placebo. Intervention 2: Intervention group: systemic propolis and local placebo. Intervention 3: Control group: local and systemic placebo. Yes - There is a plan to make this available What will be shared: data will be shared When: 2019 To whom: everybody Conditions: no condition Where to obtain: send an email: maleki.arayeh@gmail.com How to obtain: Through an email explain your request and the reason for needing the data. in 2 weeks the data will be send. Comments:
public Arayeh maleki
TUMS complex
tehran Iran (Islamic Republic of) 1212232334 +98 21 8898 7667 maleki.arayeh@gmail.com Tehran University of Medical Sciences scientific arayeh maleki
tehran TUMS complex
tehran Iran (Islamic Republic of) 1212232334 +98 21 8898 7667 maleki.arayeh@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) head and neck cancer requiring radiotherapy mucositis no limit no limit Both weak patients' cooperation allergic reaction to propolis K12.33 Oral mucositis (ulcerative) due to radiation Treatment - Drugs Treatment - Drugs Placebo Intervention group: local propolis and systemic placebo Intervention group: systemic propolis and local placebo Control group: local and systemic placebo Mucositis severity and percentage. Timepoint: baseline / 2 weeks after completing radiotherapy. Method of measurement: based on WHO. Incidence of mucositis. Timepoint: baseline. Method of measurement: starts 1-2 weeks after radiotherapy and is determined by clinical assessment. TNF in saliva. Timepoint: baseline/ 2 weeks after completing radiotherapy. Method of measurement: ELISA Kis. Tehran University of Medical Sciences Approved 2015-07-23 Ethics committee of Tehranrsity of Medical Sciences tehran TUMS complex tehran Tehran Iran (Islamic Republic of)