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IRCT20181022041418N1 IRCT 2019-06-03 Tabriz University of Medical Sciences Evaluation of grape seed extract effect on oral mucositis in patients with a history of head and neck radiotherapy G.S.E Evaluation of adjunctive effect grape seed extract(GSE) on oral mucositis in patients with a history of head and neck radiotherapy 2019-04-11 anticipated 50 Complete https://irct.ir/trial/34872 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: At first 50 patients that have investigation standards are identified.Two types of mouthwash are prepared; type 1 is grape seed extract mouthwash(25 bottles) and type 2 is placebo(25 bottles).Both patient and researcher doesn,t aware that use which type of mouthwash; only the producer of mouthwash can recognize the type of mouthwash with special codes. In the first day of radiotherapy each patient randomizely receive a bottle of mouthwash to use for two weeks. finally in the group study we have 50 patients that 25 of them have received grape seed extract mouth wash(intervention group) and 25 patients have received placebo(control group), Blinding description: Two types of mouthwashes are being prepared; type 1 is grape seed extract mouthwash and type 2 is placebo.Both patient and researcher don;t aware about the type of mouthwash; only the producer can recognize the type of mouthwash by special codes. 3 Post Radiation Mucositis. Intervention 1: Intervention group:25 patients whom will be treated under head and neck radiotherapy are being recognized and they receive 2% grape seed extract mouth wash which has been produced by Tabriz Drug Applied Center, patients use mouthwash everyday 3 times and each time for 3 minutes during 2 weeks.Patients are being examined in first-5th-10th-14th days and we record the observations. Intervention 2: Control group:25 patients whom will be treated under head and neck radiotherapy are being recognized and they receive placebo which has been produced by Tabriz Drug Applied Center. Patients use placebo everyday during radiotherapy 3 times and each time for 3 minutes.Patients use placebo for 2 weeks and be examined in first-5th-10th-14th days and observations be recorded. Yes - There is a plan to make this available What will be shared: We share only the mucositis changes after using mouthwash. When: Data will be accessible one year after printing of the results. To whom: Both researchers and mouthwash producer companies can access the documents. Conditions: In similar studies in patients with history of head and neck radiotherapy by changing the concentration of mouthwash and longer follow up it is possible.Also it is possible for evaluation the other effects of grape seed extract. Where to obtain: 1-Dr.Hosein Babaei Drug Applied Research Center Golgasht Ave,Tabriz Tel:04133363311 Email:babaei42@yahoo.com 2-Dr.Javad Ahmadi Dentistry faculty Golgasht Ave, Tabriz Tel:09144476091 Email:ahmadiadeh90@gmail.com How to obtain: At first the applicant send her/his requisition to one of respondents and after surveying and confirmation of identity and ask about the intentions, the documents are available for him. Comments:
public Dr.Hossein Eslami
Dental facualty,Golgasht Ave,Azadi Blvd
Tariz Iran (Islamic Republic of) 5166616471 +98 41333559659 eslamihosein56@yahoo.com Tabriz University of Medical Sciences scientific Dr.Hossein Eslami
Dentistry Faculty, Golgasht Ave
Tabriz Iran (Islamic Republic of) 5166616471 +98 41333559659 eslamihosein56@yahoo.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Complete consciousness Ability of reading and writing Oral mucus healthy Total radiation more than 60gray in radiotherapy duration and 2gray radiation everyday no limit no limit Both Respiratory system diseases and asthma Diabetes Autoimmune diseases Fever and Neutropenia Continuous usage of analgesics Narcotic drug usage Antibiotics usage Using another mouthwash during investigation Chemotherapy during investigation K12.33 Oral mucositis (ulcerative) due to radiation Treatment - Drugs Placebo Intervention group:25 patients whom will be treated under head and neck radiotherapy are being recognized and they receive 2% grape seed extract mouth wash which has been produced by Tabriz Drug Applied Center, patients use mouthwash everyday 3 times and each time for 3 minutes during 2 weeks.Patients are being examined in first-5th-10th-14th days and we record the observations. Control group:25 patients whom will be treated under head and neck radiotherapy are being recognized and they receive placebo which has been produced by Tabriz Drug Applied Center. Patients use placebo everyday during radiotherapy 3 times and each time for 3 minutes.Patients use placebo for 2 weeks and be examined in first-5th-10th-14th days and observations be recorded. Mucositis intensity. Timepoint: First-5th-10th-14th days after mouthwash using. Method of measurement: Mucositis grading 0-4. Tabriz University of Medical Sciences Approved 2018-09-22 Ethics committee of Tabriz Univercity of Medical Sciences Research-vice third floor,No 2 medical sciences Building Golgasht Ave Tabriz East Azarbaijan Iran (Islamic Republic of)