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IRCT20240501061615N1 IRCT 2024-08-26 Mashhad University of Medical Sciences Investigating the effect of an oil product containing essential oils of two plants and oregano on treatment-resistant head lice Evaluation of the Effect of Topical Herbal Product Based on Olive Oil and Dietary Recommendations Based on Persian Medical Resources in Patients with Resistant Head Lice Treatment 2024-09-22 anticipated 90 Complete https://irct.ir/trial/77598 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Eligible people are randomly assigned to the groups under study (the herbal product consuming group, the herbal product consuming group with dietary recommendations, and the control group) in a simple random manner and in a ratio of 1:1:1. The randomization process will be done using the online computerized random allocation sequence and through the dedicated website of the randomization process. Allocation of individuals/patients (Randomization) to the groups under study will be hidden for the patient, physician/interventionist, and outcome assessor (allocation concealment). In this way, the belonging of the people to the groups under study is marked on the paper/card and placed inside the opaque envelopes so that its contents cannot be seen from the outside. During the visit of the eligible patient for the study, the attending physician takes one of the envelopes and then opens it, and based on the contents of the envelope, the patient is placed in the intervention 1, intervention 2 or comparison/control group and treatment services are provided, Blinding description: Evaluators and analysts will be unaware of the intervention and control groups. 3 Pediculus humanus capitis. Intervention 1: Intervention group1:An oily herbal product containing the essential oils of two plants, Myrtus and oregano, will be taken topically three times at intervals of seven days. The hair is completely impregnated with the product and massaged for ten minutes, then covered with a hair cap for 2 hours, and then washed and dried with shampoo, and at the end of each treatment, an examination is done in terms of contamination and its severity. Intervention 2: Intervention group2: In addition to the oily herbal product prescribed in the first group, dietary recommendations based on traditional medicine sources were received in writing, according to the recommendations of Traditional Iranian Medicine, dietary recommendations provided to patients include avoiding the consumption of fast food, sausages, pasta, salads, high-fat foods, figs and berries, salads and yogurt with meals, consumption of liquids with and after meals, eating and Eating beef and veal during the treatment period and the examinations are the same as the first group. Intervention 3: Control group: The control group or the group that is considered as the standard group in this study is the people who will take Dimethicone 4% lotion twice with an interval of seven days. Apply dimethicone lotion to dry hair, from root to tip, then allow it to dry naturally, the lotion should be left on the head for at least 8 hours or overnight, then rinsed thoroughly with water and shampoo. 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 more information.
public Mirshahi Afsaneh
Iranian and Complementary Medicine Clinic, Amlam Reza Research and Therapeutic Hospital, Ibn Sina St
Mashhad Iran (Islamic Republic of) 9137913316 +98 51 3854 3031 mirshahia5@mums.ac.ir Mashhad University of Medical Sciences scientific Salari Roshanak
Shahid Dr. Kharazmi Educational Complex, University Campus,East Gate of Ferdowsi University of Mashhad ،Azadi Square,
Mashhad Iran (Islamic Republic of) 9177899191 +98 51 3884 8930 SalariR@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Female children with head lice who have not improved with two consecutive courses of treatment Parents' willingness to cooperate in the plan Insensitivity to plant essential oils Accessibility during research Age 6 to 12 years old No history of asthma, allergies and skin allergies according to the parents' report Absence of chronic skin disease 6 years 12 years Female Allergy history Reluctance to cooperate Allergy to oregano and myrtle B85.0 Pediculosis due to Pediculus humanus capitis Head-louse infestation Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group1:An oily herbal product containing the essential oils of two plants, Myrtus and oregano, will be taken topically three times at intervals of seven days. The hair is completely impregnated with the product and massaged for ten minutes, then covered with a hair cap for 2 hours, and then washed and dried with shampoo, and at the end of each treatment, an examination is done in terms of contamination and its severity. Intervention group2: In addition to the oily herbal product prescribed in the first group, dietary recommendations based on traditional medicine sources were received in writing, according to the recommendations of Traditional Iranian Medicine, dietary recommendations provided to patients include avoiding the consumption of fast food, sausages, pasta, salads, high-fat foods, figs and berries, salads and yogurt with meals, consumption of liquids with and after meals, eating and Eating beef and veal during the treatment period and the examinations are the same as the first group. Control group: The control group or the group that is considered as the standard group in this study is the people who will take Dimethicone 4% lotion twice with an interval of seven days. Apply dimethicone lotion to dry hair, from root to tip, then allow it to dry naturally, the lotion should be left on the head for at least 8 hours or overnight, then rinsed thoroughly with water and shampoo. The rate of complete recovery based on examination, visual visit, observation of the intention or adult lice and a questionnaire to determine the severity of the infestation. Timepoint: Examinations are generally performed 4 times upon arrival and on days 7, 14 and 21. Method of measurement: The rate of complete recovery based on examination, visual visit, observation of the intention or adult lice and a questionnaire to determine the severity of the infestation. Checking the severity of itching. Timepoint: Examinations are generally performed 4 times on arrival and on days 7, 14 and 21. Method of measurement: By completing the questionnaire. Examination of dryness in order to check complications. Timepoint: Examinations are generally performed 4 times on arrival and on days 7, 14 and 21. Method of measurement: By completing the questionnaire. Check for redness to check for complications. Timepoint: Examinations are generally performed 4 times on arrival and on days 7, 14 and 21. Method of measurement: By completing the questionnaire. Examination of skin irritation in order to investigate complications. Timepoint: Examinations are generally performed 4 times on arrival and on days 7, 14 and 21. Method of measurement: By completing the questionnaire. Mashhad University of Medical Sciences Approved 2024-04-13 Ethics committee of Mashhad University of Medical Sciences Second floor, Research and Technology Vice-Chancellor, Building number one of Mashhad University of Medical Sciences (Qureshi), in front of Daneshgah 18, Daneshgah St. Mashhad Razavi Khorasan Iran (Islamic Republic of)