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IRCT20180712040449N1 IRCT 2018-09-25 Tehran University of Medical Sciences Effect of Nigella sativa on acne vulgaris Formulation and standardization of topical product of Nigella sativa L. and study on its effects in acne vulgaris, a randomized double-blind clinical study 2018-10-21 anticipated 56 Complete https://irct.ir/trial/32524 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: To randomly assign patients to two groups of treatment and placebo by a third person and using a computer program with simple randomization method, the random sample number is generated and each patient will be assigned a number. Even numbers will be allocated to treatment with a semi-solid product, from Nigella sativa and odd numbers to placebo, Blinding description: Even numbers will be allocated to treatment with a semi-solid product from Nigella sativa and odd numbers to placebo. Letter "A" is assigned to the even number and the test drug, and letter "B" is assigned to the odd number and placebo. Patients and the person who provides the drug to patients will be blinded to the drug content. 3 Acne Vulgaris. Intervention 1: Intervention group: 28 patients receive semi-solid preparations of Nigella sativa, twice daily for 60 days. Intervention 2: Control group: 28 patients receive semi-solid preparations of placebo, twice daily for 60 days. Yes - There is a plan to make this available What will be shared: The documentation including the primary and secondary outcomes of patients that will be available When: From the start of the clinical study to one year after the completion of the clinical study To whom: If another researcher wants to perform a clinical study in this field and needs our information to do the study, the information will be provided with confidentiality. - If patients have side effects, and their doctors need the treatment information. -If a health authority's health policy requires our study information, then the information is provided with confidentiality. Conditions: If the applicant is authenticated, his request will be discussed with other researchers involved in the study, and the result will be informed to him. Where to obtain: Samaneh Soleymani S_soleymani@razi.tums.ac.ir 0098 21 66976527 How to obtain: At first, the applicants must send their request to the correspond author of the study, whose email address is on the IRCT site, and after verifying the applicant's identity, including one of the upon items, the correspond author requests information of the researchers who are present in the study and is sent to applicants. This period, after the applicant's authentication, will take about two weeks. Comments:
public Samaneh Soleymani
No. 27, Sarparast Ave, Taleghani Ave, Tehran, School of Persian medicine
Tehran Iran (Islamic Republic of) 1419814171 +98 21 8899 3656 s.soleymani84@gmail.com Tehran University of Medical Sciences scientific Samaneh Soleymani
No. 27, Sarparast Ave, Taleghani Ave, Tehran, School of Persian medicine
Tehran Iran (Islamic Republic of) 1419814171 +98 21 8899 3656 s.soleymani84@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Patients between 14–35 years old from both genders Patients with mild to moderate acne as defined by the Investigator’s Global Assessment (IGA) scale Enrolled female participants should have a negative pregnancy test 14 years 35 years Both Any aesthetic facial procedure including laser therapy and tissue/dermal injectables within the last 6 months Patients having wound and infection on face Patients with any skin disorders that might interfere with the diagnosis or evaluation of acne Very severe acne vulgaris Pregnancy or breastfeeding Patients with any uncontrolled systemic disease Using oral isotretinoin in the last 6 months History of hypersensitivity to blackseed L70.0 Acne vulgaris Treatment - Drugs Placebo Intervention group: 28 patients receive semi-solid preparations of Nigella sativa, twice daily for 60 days. Control group: 28 patients receive semi-solid preparations of placebo, twice daily for 60 days. People with mild to moderate acne vulgaris. Timepoint: Acne lesions counting at baseline, days 14, 30, and 60. Method of measurement: Investigator’s global assessment grading for acne vulgaris. Tehran University of Medical Sciences Approved 2018-07-04 Vice-Chancellor in Research Affairs of Tehran University of Medical Sciences Vice-Chancellor in Research Affairs of Tehran University of Medical Sciences, Ghods Ave, Keshavarz Blvd, Tehran Tehran Tehran Iran (Islamic Republic of)