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IRCT20191106045356N21 IRCT 2024-09-18 Yazd University of Medical Sciences Formulation of a topical gel containing Lawsonia inermis extract and Aloe vera and evaluation its effects on the healing process of second degree burns. Formulation of a topical gel containing Lawsonia inermis extract and Aloe vera and evaluation its effects on the healing process of second degree burns: A randomized double_blinded placebo_controlled trial. 2024-10-21 anticipated 48 Complete https://irct.ir/trial/66365 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients who meet the inclusion criteria are placed in one of two treatment groups with products containing Henna and Aloe vera (group A) or Silver sulfadiazine (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 as the evaluator do not know the composition and content of each drug container. 3 Second degree burn. Intervention group: It includes 24 patients referred to the Shohadaye Mehrab Hospital who meet the inclusion criteria, whose order and type of intervention is random based on the ( RAND) function of Excel software. Patients in the intervention group use a topical gel containing Henna and Aloe vera extract prepared at the Faculty of Pharmacy of Shahid Sadoughi University of Medical Sciences in Yazd twice a day. After starting treatment, the condition of the lesion is evaluated for 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. Mohammad Reza Lotfaliani
Alem sq.
Yazd Iran (Islamic Republic of) 8915173149 +98 35 3820 3419 Lotf726@yahoo.com Yazd University of Medical Sciences scientific Dr. Mohsen Zabihi
Faculty of Pharmacy Shahid Sadoughi University of Medial sciences
Yazd Iran (Islamic Republic of) 8915173149 +98 35 3820 3410 mzabihi100@gmail.com Yazd University of Medical Sciences Iran (Islamic Republic of) Patients with second degree burns Patients aged 18 to 65 years 18 years 65 years Both Patients with skin diseases Pregnant women Allergy to henna or Aloe vera T30.0 Burn of unspecified body region, unspecified degree Treatment - Drugs Intervention group: It includes 24 patients referred to the Shohadaye Mehrab Hospital who meet the inclusion criteria, whose order and type of intervention is random based on the ( RAND) function of Excel software. Patients in the intervention group use a topical gel containing Henna and Aloe vera extract prepared at the Faculty of Pharmacy of Shahid Sadoughi University of Medical Sciences in Yazd twice a day. After starting treatment, the condition of the lesion is evaluated for redness, dryness, itching, burning and pain ( score 0 to 4). Severity of erythema or redness. Timepoint: During and after treetment, every two days, the skin condition is evaluated for the severity of redness, dryness, itching, burning and pain. Method of measurement: Scoring erythema or redness using a questionnaire. Yazd University of Medical Sciences Approved 2023-01-11 Ethics committee of the Faculty of Medicine, Shahid Sadougi University of Medical Sciences, Yazd Alem sq. Yazd Yazd Iran (Islamic Republic of)