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IRCT20100119003106N42 IRCT 2022-07-05 Islamic Azad University Evaluation of therapeutic effect of topical semi-solid product containing sucralfate, zinc oxide, aloe Vera gel and peppermint essential oil and zinc oxide ointment in natural base containing Ghee oil and comparison with standard treatment containing zinc oxide in normal base in the process of healing and treatment of diaper rash Evaluation of therapeutic effect of topical semi-solid product containing sucralfate, zinc oxide, aloe Vera gel and peppermint essential oil and zinc oxide ointment in natural base containing Ghee oil and comparison with standard treatment containing zinc oxide in normal base in the process of healing and treatment of diaper rash: a pilot study And parallel 2022-08-06 anticipated 60 Complete https://irct.ir/trial/62492 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Zu diesem Zweck werden 60 Umschläge (20 mit der ersten Arzneimittelkarte und 20 mit der zweiten Arzneimittelkarte und 20 mit der Placebokarte) vorbereitet. Umschläge sind mit Nummern von 1 bis 40 gekennzeichnet. Die Patienten werden nach dem Öffnen des versiegelten Umschlags einer von zwei Medikamenten- bzw. Placebogruppen, Nummer 1 bis 40, zugeordnet, Blinding description: The patients, physicians, researcher and data collector (student) don’t know about who was receiving the placebo and who receiving a placebo. The informed consent was obtained from patients and they were informed that they could leave the trial at any time. The coding of the medicine boxes was done by a third party who was not involved in the study and at the end of the study, decryption took place. All tubes of the drug are the same in terms of design and color, while the cover of the prescribed tubes is coded. 2-3 Diaper rash. Intervention 1: Intervention group: The first intervention group of patients receiving medicine containing zinc oxide and sucralfate and aloe vera gel and peppermint essential oil (made by Pharm.D. students in pharmaceuticals lab in Azad university) for 7 days after each diaper change. Intervention 2: Intervention group: the second intervention group received animal oil made by researchers of the Faculty of Pharmacy of Tehran Azad University of Medical Sciences for 7 days after each diaper change. Intervention 3: Control group: Patients take placebo medicine made by researchers of the Faculty of Pharmacy of Tehran Azad University of Medical Sciences, which contains zinc oxide and the usual base for 7 days after each diaper change. Yes - There is a plan to make this available What will be shared: All the data potentially can be shared after being unidentifiable. When: Just after the articles publication. To whom: For all investigators. Conditions: The person requesting the data should be a relevant expert in this field - All statistical analyzes performed can be provided - Information can be used by mentioning the name of the research and referencing the site to the research - Requirements: Mentioning the name of the research and codes Relevant research and all the required information as well as the name of the researcher and communication channels in case of receiving the required information. Where to obtain: Application can refer to the Department of Clinical Pharmacy, Faculty of pharmacy, Tehran Medical Science, Islamic Azad University, Dr. Hashemian or contact the researcher by sending email to shabanelahe@gmail.com or calling 09210907926. How to obtain: Application can apply for research information by visiting the department or by contacting the e-mail address and telephone number as well as providing information on academic studies and the purpose of requesting the information. Applicant must commit themselves to mention the source. If the request is sent six months after the publication of research information the researcher will send the data to the requesting party by email within a week. Comments:
public Elaheh Shaban
No 99, Yasman Alley, Yakhchal street, Gholhak, Dr. Shariati street
Tehran Iran (Islamic Republic of) 193956466 +98 21 2264 0051 shabanelahe@gmail.com Islamic Azad University scientific Dr. Farshad Hashemian
No 99, Yasman Alley, Yakhchal street, Gholhak, Dr. Shariati street
Tehran Iran (Islamic Republic of) 193956466 +98 21 2264 0599 hashemian.f@iaups.ac.ir Islamic Azad University Iran (Islamic Republic of) Doctor's diagnosis of having diaper rash Age between one day to 24 months Parental consent to cooperate and use medication 1 day 2 years Both Existence of deep ulcers, infection or fungal lesions, need for treatment with other drugs such as corticosteroids and antibiotics. Bloody stools Fever Underlying diseases History of allergies to topical products containing zinc, aloe Vera or products contains essential oil of mint, and cow's milk protein L22 Diaper dermatitis Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group: The first intervention group of patients receiving medicine containing zinc oxide and sucralfate and aloe vera gel and peppermint essential oil (made by Pharm.D. students in pharmaceuticals lab in Azad university) for 7 days after each diaper change. Intervention group: the second intervention group received animal oil made by researchers of the Faculty of Pharmacy of Tehran Azad University of Medical Sciences for 7 days after each diaper change Control group: Patients take placebo medicine made by researchers of the Faculty of Pharmacy of Tehran Azad University of Medical Sciences, which contains zinc oxide and the usual base for 7 days after each diaper change. Diaper Dermatitis Grading Scale. Timepoint: The beginning of the study (before the intervention) and the second, fourth, sixth days and after the intervention. Method of measurement: Diaper Dermatitis Grading Scale. Islamic Azad University Approved 2022-02-21 Ethics committee of Islamic Azad University, Pharmaceutical Sciences Branch Islamic Azad University, Pharmaceutical Sciences Branch, Dr. Shariati Ave., Qolhak., Yakhchal St., Yasaman Ave., Tehran Town Tehran Tehran Iran (Islamic Republic of)