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IRCT20181005041243N4 IRCT 2024-07-08 Iranian academic center for education culture and research Therapeutic effect of ointment containing extract of Arbenia Euchromia plant and amniotic membrane in burn wound Assessing therapeutic effects of a topical ointment containing the extract of Arnebia euchroma and amniotic membrane in patients with burn; a randomized controlled trial 2024-09-01 anticipated 60 Complete https://irct.ir/trial/77665 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Allocation of individuals to groups is done in the form of random allocation in blocks of four. In this way, first the volume of each block is specified (block of four), then the list of blocks is specified with the help of www.randomizer.org and numbers are assigned to them (numbers 1 to 15 for 60 people) and each of the numbers with the list of treatment specific to you is placed in an envelope. Then, the people included in the research randomly select envelopes containing numbers between 1 and 15, and the allocation of people to two groups 1 and 2 is determined based on the list of four blocks of each number, Blinding description: A label is placed on the can containing the drug and 1% silver sulfadiazine. The number 1 or 2 is written on the sticker of the can containing medicine (extract) and the number 1 or 2 is written on the label of the can containing 1% silver sulfadiazine. Other specifications included on the said labels are completely the same. The patient and other people are unaware of the nature and meaning of the numbers 1 and 2 on the label. The place of blinding is in the research institute. 2-3 Burn wound. Intervention group: Ointment name: Arnebia euchroma, chemical composition and its concentration: extracts are prepared by soaking plant materials in (67%-EtOH) under ultrasound at room temperature. The extracts will be filtered through Whatman No. 1 filter paper, and then the filtrates were successively combined and concentrated under vacuum by a rotary evaporator. Then, in a special mill, the dry extract will be mixed with the oily base composition and it will be kept for 73 hours in a special tank in the dark at a temperature of 37 degrees Celsius. The final product is sterilized by gamma radiation (23 kg). Dosage: In both groups, after washing the burn wound with 0.9% sterile saline solution, the wound is placed in the vicinity of the open air for 5 minutes until its surface is completely dry, then using a sterile water hose to complete the measurements. The surface of the burn wound should be covered with a thickness of 3 mm, ointment number 1 or 2 is applied to the wound, and a layer of sterile gauze is placed on the wound. Wound dressings are changed daily for up to 14 days.. Yes - There is a plan to make this available What will be shared: Part of the data, such as the information related to the main outcome, can be shared. All information will be published in the form of a work report and finally a scientific article. If you need all the data, it is possible for the person in charge of the plan to provide the information without patients being identifiable. When: The access period starts immediately after the results are printed To whom: Only researchers working in academic and scientific institutions Conditions: The data will only be given to researchers who are researching the same topic. Where to obtain: Responsible for the project: Dr. Maryam Nasimi Address: Razi Hospital, Vahdat Eslami St. Number: 09128435986 Email: nsm.maryam@gmail.com How to obtain: After sending a reasonable request to the person in charge of the project by email, if the conditions are met, the information will be shared with them. Comments:
public Dr. Maryam Nasimi
Razi Hospital, Vahdate eslami St.
Tehran Iran (Islamic Republic of) 11996 63911 +98 21 5563 0553 nsm.maryam@gmail.com Tehran University of Medical Sciences scientific Dr. Maryam Nasimi
Razi Hospital, Vahdate eslami St.
Tehran Iran (Islamic Republic of) 11996 63911 +98 21 5563 0553 nsm.maryam@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) age between 18-60 Burns due to contact with hot liquids or heat sources, patients with second degree burns according to the criteria determined according to the reference sources as follows: 1. The surface of the burn is red or pink in color. 2- It has a moist surface with liquid oozing or accompanied by blisters. 3- Having extreme sensitivity when touching The extent of the burn wound is between 1 and 10%, which is determined based on the criteria of Lund and Browder Less than 6 hours should pass from the occurrence of the burn to the time the patient goes to the treatment center The patient's wound was free of infection and trauma The wound of the patient should be only on the limbs and trunk and not in the head, face and genital area. 18 years 60 years Both Suffering from diseases such as anemia, diabetes, malignancies and immune system defects due to the impact on the wound healing process. Taking drugs that weaken the immune system and are effective on wound healing, such as steroid drugs - substance abuse The patient's unwillingness to continue participating in the research or not returning to the treatment center Damage to the burn wound during the intervention, chemotherapy or radiation therapy during the research and showing signs of sensitivity to 1% silver sulfadiazine or the study drug during the intervention pregnancy Treatment - Drugs Intervention group: Ointment name: Arnebia euchroma, chemical composition and its concentration: extracts are prepared by soaking plant materials in (67%-EtOH) under ultrasound at room temperature. The extracts will be filtered through Whatman No. 1 filter paper, and then the filtrates were successively combined and concentrated under vacuum by a rotary evaporator. Then, in a special mill, the dry extract will be mixed with the oily base composition and it will be kept for 73 hours in a special tank in the dark at a temperature of 37 degrees Celsius. The final product is sterilized by gamma radiation (23 kg). Dosage: In both groups, after washing the burn wound with 0.9% sterile saline solution, the wound is placed in the vicinity of the open air for 5 minutes until its surface is completely dry, then using a sterile water hose to complete the measurements. The surface of the burn wound should be covered with a thickness of 3 mm, ointment number 1 or 2 is applied to the wound, and a layer of sterile gauze is placed on the wound. Wound dressings are changed daily for up to 14 days. Determining the extent of the wound and the time required to heal the wound. Timepoint: At the beginning of the study (before the start of the intervention) and 14 days after starting to use ointments. Method of measurement: The size of the wound is determined by a ruler and the time required to heal the wound is determined by a doctor's visit. Edema; hematoma; itching; pain; infection. Timepoint: At the beginning of the study (before the start of the intervention) and 14 days after starting to use ointments. Method of measurement: doctor's opinion. Iranian academic center for education culture and research Approved 2024-06-26 Ethics committee of Tehran University of Medical Sciences Ghods St., Keshavarz Blvd, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)