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IRCT20160306026938N12 IRCT 2022-10-18 Tehran University of Medical Sciences Evaluation of efficacy of Peganum harmala extract on patients with head lice Evaluation of the efficacy of a formulation of Peganum harmala aqueous extract on patients with head lice 2022-12-12 anticipated 25 Complete https://irct.ir/trial/66124 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment. 2 Head lice. Intervention group: recipient of gel formulation containing aqueous extract of Peganum harmala plus carbomer and sodium hydroxide. In three consecutive days, once a day, the patient smears all the infected areas and the skin of his head and neck with gel and after ten minutes, he washes the stained areas with softening shampoo and water.. Yes - There is a plan to make this available What will be shared: En Demographic specification of patients, would be published, except their names and address. Primary outcome of the patients would be published, too. When: En Data would be available 6 months after publishing the results To whom: Data would be available for researchers in academic and scientific organisations Conditions: any type of usage of data is allowable, except using for manufacturing a product. Where to obtain: Sending an E. mail to mehdivazirian@gmail.com How to obtain: After receiving E. mail, data would be sent within a week Comments:
public Mahdi Vazirian
Room No. 1-206, Second Floor, Old buliding, Faculty of Pharmacy, 16th Azar Ave., Enqelab Ave.
Tehran Iran (Islamic Republic of) 1417614411 +98 21 6412 1223 Vazirian_m@tums.ac.ir Tehran University of Medical Sciences scientific Mahdi Vazirian
Room No. 1-206, Second Floor, Old buliding, Faculty of Pharmacy, 16th Azar Ave., Enqelab Ave.
Tehran Iran (Islamic Republic of) 1417614411 +98 21 6412 1223 Vazirian_m@tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Conformity with head lice diagnostic criteria Age range between 18 and 65 years Signing informed consent Being in healthy condition Not using local or systemic anti-lice products during the recent infection 18 years 65 years Both Local or systemic anti-lice treatment or use of hair dye during or before the study period Having serious diseases or extensive wounds, especially in the scalp area (such as impetigo or eczema), chronic scalp disorders (such as psoriasis, chronic dermatosis) and secondary scalp infection known allergy to any of the components of the product Treatment with antibiotics (cotrimoxazole, trimethoprim, tetracycline) or anthelmintics (such as ivermectin, levamisole, albendazole) in the last 1 month or other local or systemic drugs that may lead to errors in the test B85.0 Pediculosis due to Pediculus humanus capitis Treatment - Drugs Intervention group: recipient of gel formulation containing aqueous extract of Peganum harmala plus carbomer and sodium hydroxide. In three consecutive days, once a day, the patient smears all the infected areas and the skin of his head and neck with gel and after ten minutes, he washes the stained areas with softening shampoo and water. Lice levels. Timepoint: Before the initiation of intervention and the day after the last application of formulation. Method of measurement: Scoring the patients' symptoms based on a 0-10 Likert Scale with regard to improvements in symptoms (0=no improvement; 10= complete improvement). Quality of life. Timepoint: Before the start of the intervention and one day after the last use of the formulation. Method of measurement: Completion of a 30-question questionnaire on the quality of life of head lice patients by the patient. Tehran University of Medical Sciences Approved 2022-09-20 Research Ethichs Committees of The Institute of Pharmaceutical Sciences- Tehran University Of Medica 16 Azar Avenue, Tehran University of Medical Sciences, Faculty of Pharmacy, The Institute of Pharmaceutical Sciences, 2nd floor, Unit 1-219، tehran Tehran Iran (Islamic Republic of)