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IRCT20191106045356N7 IRCT 2021-08-01 Yazd University of Medical Sciences Formulation of a topical gel containing Lawsonia inermis and Aloe vera and evaluation its effects on radiation-induced dermatitis Formulation of a topical gel containing Lawsonia inermis and Aloe vera and evaluation its effects on radiation-induced dermatitis: A randomized double-blinded placebo-controlled trial 2021-08-21 anticipated 56 Complete https://irct.ir/trial/57643 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients who meet the inclusion criteria are placed in one of two treatment groups with products containing aloe vera and henna (group A) or base hydrogel (group B). Randomization is performed based on the RAND () function of Excel software, and based on this, a table of random numbers is prepared, and patients are placed in groups A or B, respectively, in the rows of this table, and receive the product related to their group, Blinding description: Different groups of drugs are placed in uniform and coded containers, and the prescribing physician and the evaluator do not know the composition and content of each drug container. 3 Dermatitis. Intervention 1: Intervention group: It includes 25 patients referred to the radiotherapy center who meet the inclusion criteria, whose order and type of intervention is random based on the RND () function of Excel software. Patients in the intervention group use a hydrogel containing henna and aloe vera extract prepared once a day for ten days in the Faculty of Pharmacy of Shahid Sadoughi University of Medical Sciences in Yazd. After starting treatment, the condition of the lesion is evaluated for loss of epidermis, redness, dryness, itching, burning, and pain (score 0 to 4). Intervention 2: Control group: It includes 25 patients referred to the radiotherapy center who meet the inclusion criteria, whose order and type of intervention is random based on the RAND() function of Excel software. Patients in the control group use a hydrogel base prepared in the Faculty of Pharmacy of Shahid Sadoughi University of Medical Sciences in Yazd, once a day for ten days. After starting treatment, the condition of the lesion is evaluated for loss of epidermis, redness, dryness, itching, burning, and pain (score 0 to 4). 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 There is no further information
public Dr. Mohsen Zabihi
Alem sq.
Yazd Iran (Islamic Republic of) 8915173149 +98 35 3820 3419 mzabihi100@gmail.com Yazd University of Medical Sciences scientific Dr. Mohsen Zabihi
Alem sq.
Yazd Iran (Islamic Republic of) 8915173149 +98 35 3820 3419 mzabihi100@gmail.com Yazd University of Medical Sciences Iran (Islamic Republic of) Patients starting radiotherapy Patients aged 18 to 65 years 18 years 65 years Both Patients with skin diseases Allergy to henna or aloe vera use the medicine for two consecutive days Severe systemic diseases such as uncontrolled diabetes, epilepsy, immune system defects, etc. Occurrence of local infection and swelling and redness at the site of dermatitis Incidence of dermatitis and the need for medical treatment of the patient L30.9 Dermatitis, unspecified Treatment - Drugs Placebo Intervention group: It includes 25 patients referred to the radiotherapy center who meet the inclusion criteria, whose order and type of intervention is random based on the RND () function of Excel software. Patients in the intervention group use a hydrogel containing henna and aloe vera extract prepared once a day for ten days in the Faculty of Pharmacy of Shahid Sadoughi University of Medical Sciences in Yazd. After starting treatment, the condition of the lesion is evaluated for loss of epidermis, redness, dryness, itching, burning, and pain (score 0 to 4). Control group: It includes 25 patients referred to the radiotherapy center who meet the inclusion criteria, whose order and type of intervention is random based on the RAND() function of Excel software. Patients in the control group use a hydrogel base prepared in the Faculty of Pharmacy of Shahid Sadoughi University of Medical Sciences in Yazd, once a day for ten days. After starting treatment, the condition of the lesion is evaluated for loss of epidermis, redness, dryness, itching, burning, and pain (score 0 to 4). Severity of erythema or redness. Timepoint: During and after treatment, every ten days, the skin condition undergoing radiotherapy is evaluated for the severity of redness, dryness, itching, burning and pain. Method of measurement: Scoring erythema or redness using a questionnaire. Severity of itching. Timepoint: During and after treatment, every ten days, the skin condition undergoing radiotherapy is evaluated for the severity of redness, dryness, itching, burning and pain. Method of measurement: Scoring itching using a questionnaire. Severity of pain. Timepoint: During and after treatment, every ten days, the skin condition undergoing radiotherapy is evaluated for the severity of redness, dryness, itching, burning and pain. Method of measurement: Scoring pain using a questionnaire. Skin dryness score. Timepoint: During and after treatment, every ten days, the skin condition undergoing radiotherapy is evaluated for the severity of redness, dryness, itching, burning and pain. Method of measurement: Scoring skin dryness using a questionnaire. Yazd University of Medical Sciences Approved 2021-05-19 Ethics committee of shahid sadoughi university medical Alem sq. Yazd Yazd Iran (Islamic Republic of)