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IRCT20221028056322N1 IRCT 2022-11-28 Shahre-kord University of Medical Sciences The effect of mouthwash of hydroalcoholic extract of Iranian oak jaft MDCHR The effect of mouthwash of hydroalcoholic extract of 15% of Iranian oak jaft (Quercus brantii) on prevention, pain intensity and extent of oral mucosa in cancer patients undergoing chemotherapy and radiotherapy, a randomized trial study 2021-06-21 anticipated 80 Complete https://irct.ir/trial/66593 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Other design features: In this study, random allocation of drugs was done. If in parallel studies, random allocation of patients to two control and intervention groups was done, Randomization description: In the present study, a sampling method was used based on the census of all cancer patients referred, hospitalized or outpatients to the chemotherapy and radiotherapy departments of Shahrekord Parsian Hospital and clinics that met the conditions for inclusion in the study. Then by randomly allocating drug and placebo to all patients who meet the conditions for entering the study, the subjects were studied, Blinding description: The target population consisted of 80 people in the present study, who were selected from among cancer patients referred, hospitalized or outpatients in the chemotherapy and radiotherapy departments of Parsian Shahrekord Hospital and clinics, using the census-based sampling method. Then, the patients were studied by simple random assignment of drug and placebo to all patients who meet the conditions for entering the study. Identical containers containing drug and placebo were coded by the Medicinal Plants Study Center of Shahrekord University of Medical Sciences under the supervision of respected professors of medicinal plants and kept in the refrigerator until delivery to the patients. The method of coding has been such that the researcher of the contents and the included codes. 3 Oral mucositis caused by chemotherapy and radiotherapy. Intervention group: In both intervention and control groups, drug or placebo was randomly assigned.. No - There is not a plan to make this available Justification or reason for not sharing IPD is busy work
public Mohammad Reza Kiani
Shariati Street, Koche 22, Mehr Complex
SHahre kord Iran (Islamic Republic of) 8816758915 +98 38 3333 5277 mohammadrezakianisalmi57@gmail.com Shahre-kord University of Medical Sciences scientific Jafar Moghdisi
Shahrekord, Kashani Blvd., University Headquarters, Building No. 2
SHahre kord Iran (Islamic Republic of) ۸۸۱۵۷۱۳۴۷۱ +98 38 3333 2907 moghadasi@skums.ac.ir Shahre-kord University of Medical Sciences Iran (Islamic Republic of) does not have any underlying immune system defects. Be free of any mucositis at the time of entering the study. Having informed and written consent from the patient or the patient's guardian to participate in the study. Age above 15 years under chemotherapy or radiotherapy, but patients have not undergone radiotherapy or chemotherapy in the last three months. 15 years no limit Both Age below 15 years Prevention Intervention group: In both intervention and control groups, drug or placebo was randomly assigned. Incidence rate, severity of pain and severity of oral mucositis. Timepoint: Before, one or two weeks after the intervention. Method of measurement: World Health Organization Mucositis Severity Measurement Tool and Pain Visual Analogue. Patient comfort level. Timepoint: Before, one or two weeks after the intervention. Method of measurement: Visual analogue of pain. Shahre-kord University of Medical Sciences Approved 2021-05-06 Ethics committee of shahre kord university of Medical Sciences Address: Shahrekord, Kashani Boulevard, University Headquarters, Building No. 2 Postal Code: 8815713471 Phone: 038-33342414 vcrt@skums.ac.ir SHahrekord Chahar-Mahal-va-Bakhtiari Iran (Islamic Republic of)