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IRCT20170404033202N11 IRCT 2022-07-29 Sabzevar University of Medical Sciences Evaluation of PlantagoĜŒMarigold and honey (traditional medicine product) with placebo on dermatitis caused by radiotherapy in cancer patients Evaluation of PlantagoĜŒMarigold and honey (traditional medicine product) with placebo on dermatitis caused by radiotherapy in cancer patients 2023-02-20 anticipated 84 Complete https://irct.ir/trial/64859 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: 84 cases were selected and were randomly divided into two groups each consisted of 42 subjects. (Simple, individual randomization is done by choosing a sealed envelope), Blinding description: In this way, the patient and the examiner do not know the type of drug used. The drug and the placebo are the same in terms of shape, color and appearance as an ointment. 3 radiation therapy-induced dermatitis. Intervention 1: Intervention group: Intervention group: The medicine of the intervention group is hydrogel, which includes marigold, marshmallow, and honey. This topical skin hydrogel will be made by a pharmacist under the supervision of the Mashhad Faculty of Pharmacy. On the days when patients come for treatment (radiotherapy), immediately after radiotherapy and 6 hours after radiotherapy A thin layer (one finger) of the traditional medicine product is applied to the dermatitis or radiation therapy site (skin folds including axillary, underbreast, groin). Intervention 2: Control group: The medicine of the control group, the ointment, contains hydrogel. This topical hydrogel will be made by a pharmacist under the supervision of the Mashhad Faculty of Pharmacy. The patients of the control group, on the days they come for treatment (radiotherapy), apply a thin layer (a thin layer) immediately after radiotherapy and 6 hours after radiotherapy. They apply the hydrogel to the place of dermatitis or radiation therapy (skin folds including axillary, underbreast, groin). Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is The Data is confidential
public Atefeh Asadi
Enghelab
Sabzevar Iran (Islamic Republic of) 9618655555 +98 51 4422 9081 a.asadi.mm.1384@gmail.com Sabzevar University of Medical Sciences scientific Atefah Asadi
Enghelab
Sabzevar Iran (Islamic Republic of) 9618655555 +98 51 4422 9081 a.asadi.mm.1384@gmail.com Sabzevar University of Medical Sciences Iran (Islamic Republic of) Consent to participate in the study Mental and intellectual health Radiotherapy candidate Staying in Bezvar and suburbs (all meetings should be held in Bezvar) Age range 45-70 years Absence of underlying chronic disease: dermatology, lupus, active scleroderma, underlying allergy, diabetes, and chronic kidney disease No smoking, drugs and alcohol 45 years 75 years Both People who have changed their place of residence since the middle of the study Do not agree to continue participating in the project from the middle of the study suffer severe complications from radiotherapy. Changing the patient's treatment method from the middle of the treatment process Failure to use plan drugs have allergies to study drugs L58.9 Radiodermatitis, unspecified Treatment - Other Placebo Intervention group: Intervention group: The medicine of the intervention group is hydrogel, which includes marigold, marshmallow, and honey. This topical skin hydrogel will be made by a pharmacist under the supervision of the Mashhad Faculty of Pharmacy. On the days when patients come for treatment (radiotherapy), immediately after radiotherapy and 6 hours after radiotherapy A thin layer (one finger) of the traditional medicine product is applied to the dermatitis or radiation therapy site (skin folds including axillary, underbreast, groin). Control group: The medicine of the control group, the ointment, contains hydrogel. This topical hydrogel will be made by a pharmacist under the supervision of the Mashhad Faculty of Pharmacy. The patients of the control group, on the days they come for treatment (radiotherapy), apply a thin layer (a thin layer) immediately after radiotherapy and 6 hours after radiotherapy. They apply the hydrogel to the place of dermatitis or radiation therapy (skin folds including axillary, underbreast, groin). Dermatitis. Timepoint: Day 0 (day of starting radiation therapy and start of intervention) and days 7-14-21 after the treatment and one month after the end of the treatment to check acute dermatitis and 3 months after the end of treatment to check sub-acute dermatitis. Method of measurement: CTCAE v5.0. Itching. Timepoint: (From start of intervention) to day 7-21-28 (from the start of radiotherapy once a week). Method of measurement: self expression. Erythema. Timepoint: (From start of intervention) to day 7-21-28 (from the start of radiotherapy once a week). Method of measurement: view. Sabzevar University of Medical Sciences Approved 2022-06-25 Ethics committee of Sabzevar University of Medical Sciences pardis of Sabzevar University of Medical Sciences Sabzevar Razavi Khorasan Iran (Islamic Republic of)