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.

Determining the effectiveness of gel containing Henna and Aloe vera extract on the healing process of second degree burns.

This study is a clinical trial with a control group, with parallel groups, double_blind, randomized, phase3, which is performed on 48 patients, using RAND function of Excel software for randomization.

It is a double_blind randomized controlled clinical trial. Patients receive a uniform product so that neither the physician nor the patient is aware of the content of the dosage form. Patients who meet the inclusion criteria will be included in the study after obtaining written consent and their information including age, gender, weight, underlying diseases, and medications will be extracted from the file. Patients receive one of the products containing Henna and Aloe vera extract or silver sulfadiazine twice a day for 10 days without dressing on the burn site. Patients are instructed to use only the products mentioned in the study and the necessary warnings about using other products. During and after treatment, on days 1, 2, 4, 7, 10, 15 and 30 the skin condition is evaluated for the severity of redness, dryness, itching, burning, and pain (score 0 to 4).

Patients with second degree burns aged between 18 and 65 years.

Twice a day consumption of gel containing Henna extract and Aloe vera or Silver sulfadiazine.

The severity of erythema or redness, itching, burning or pain, dry skin

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.

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.