Investigating the healing effects of topical spray containing effective herbal ingredients on ‎burn wounds of patients with grade 1 and 2 burn wound

Investigating the healing effects of topical spray containing effective herbal ingredients on ‎burn wounds of patients with grade 1 and 2 burn wound

A controlled, triple-blind, randomized, phase 3 clinical trial on 40 patients. To randomize the patients, the random block method with a block size of four is used

The study will be conducted on burn patients referred to Hamadan (Iran) hospitals. Placebo and herbal formulation will be prepared by researcher in two similar containers. The herbal formulation container will be labeled as X and the the placebo container will be labeled as Y and only the researcher is aware of the container's contents. Neither the participant nor the clinician nor the statistical analyst know about the contents of the labeled containers.

Inclusion criteria: Patients (men and women) from the age of 10 to 70 years with 2nd and 3rd degree burns involving least 1 cm 2‎ of their body surface area. Exclusion criteria: hypersensitivity to herbal formulations; have a history of asthma or chronic obstructive pulmonary diseases; patients with diabetic ulcers; patients with skin lesions.

The first group, test 1: in this group, the burn wounds will be treated with silver sulfadiazine cream in the morning and 12 hours later the wounds will be treated with herbal spray, the second group, test 2: the burn wounds will be treated with herbal spray every 12 hours, the third group, the positive control group: the burn wounds will be treated with silver sulfadiazine every 12 hours and the fourth group, the placebo control group: the wounds will be treated with SSD every morning and12 hours later with placebo. ​

Faster and more effective healing of burn wound by herbal formulation compared to placebo

To randomize the patients, the random block method with a block size of four is used. For this purpose, four sheets of paper are prepared. The letter T (test) is written on two sheets and the letter C (control) is written on the other two sheets. The sheets are mixed together and placed in a box. With each eligible patient's visit, one of the sheets is randomly drawn and based on whether the drawn sheet is T or C, it is assigned to one of the two test or control groups. It should be noted that the drawn cards are not returned to the box until all four cards have been drawn. After all four sheets are randomly drawn, all sheets are returned to the corresponding box and the above operation is continued for the next four patients until the desired sample size is reached. The method of blinding herbal formulation and placebo is prepared by the researcher and prepared in a spray container and provided to the doctor and shift nurse. The container containing the solution of active herbal ingredients are marked as X and the bottles containing the placebo are marked as Y, and only the researcher is aware of the contents of the spray bottles, the examining doctor and nurse, the patient himself and The statistical analyst does not know any of the content inside the labeled container ​