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IRCT20191211045692N1 IRCT 2020-04-01 Iran University of Medical Sciences Efficacy of flax seed oil in treating mild to moderate psoriasis vulgaris comparing with topical Bethamethasonel Efficacy of flax seed oil in treating mild to moderate psoriasis vulgaris comparing with topical Bethamethasone: A randomized, double-blind, clinical trial 2020-02-09 anticipated 50 Complete https://irct.ir/trial/44113 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: A random number is allotted the patients, through the table of random numbers; a sealed envelope is delivered to him, and a random code is allocated to his medicine box. Data analysis is performed by the statistical software, Blinding description: - The participants will receive a code, based on the table of random numbers; then, according to the code, they will receive one of the containers containing the product or Betamethasone. Both medicines are in the same containers with a uniform shape and color, and the patient will receive a treatment container and medicine, merely based on the code, inserted on the treatment box. This code will be repeated by the end of the study, neither the clinical observer nor the patient will be aware of the received medicine type, and only the container code will be given to them. N/A PSORIASIS VULGARIS PLAQUE TYPE. Intervention 1: - Intervention group: in this group, the certified flax seed oil, produced by Barij Essence Co., will be applied in the form of an ointment, delivered to the patient in the containers with a uniform appearance, applied on the lesions twice a day, and given a massage. The patient will apply the ointment from the beginning of the study, be reevaluated by a physician, and the related questionnaires will be filled out at the end of the first month. To avoid any disruption in the observation and evaluation processes to fill the questionnaires, the primary and final patient’s evaluations will be performed by the same personnaires will be completed. Intervention 2: - Control group: in this group, Betamethasone ointment will be applied in the same container; the patients will be examined at the beginning of the study and the end of the first month by a physician, based on the questionnaires. Betamethasone ointment will be given to the patients in the same and uniform containers; it must be applied on lesions twice a day, and given massages. n the lesions and massaged. 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 No more information
public Farshad Mohammadian Rasanan
No .42, Dadman blv, Shahrake Gharb, Tehran, Iran
Tehran Iran (Islamic Republic of) 1467764513 +98 21 8837 6260 fmr4077@yahoo.com Iran University of Medical Sciences scientific Farshad Mohammadian Rasanan
No.42, Dadman Blv, Shahrake Garb
Tehran Iran (Islamic Republic of) 1467764513 +98 21 8837 6260 mohammadian.fa@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) Type of psoriasis vulgaris disease with mild to moderate plaque type - Not to suffer underlying diseases disrupting the therapy, such as obesity, pregnancy, dialysis, AIDS, psychotic disorder, thyroid and parathyroid T d iseases Not to use medicines affecting psoriasis disease, such as Beta-blocker, lithium, anti-malaria, corticosteroids and systemic steroids, calcium channel blockers, interleukin Confirmation of clinical diagnosis by a dermatologist 18 years 60 years Both - Suffering each of the abovementioned diseases or confirming the diagnosis of any disease, interfering with the treatment, and mentioned in the inclusion criteria, in any moment of the treatment cycle - Patient dissatisfaction with going on the treatment Any physical and chemical trauma and surgery, which inevitably makes the patient involved, and leads to the disease exacerbation L40.0 Psoriasis vulgaris Treatment - Drugs Treatment - Drugs - Intervention group: in this group, the certified flax seed oil, produced by Barij Essence Co., will be applied in the form of an ointment, delivered to the patient in the containers with a uniform appearance, applied on the lesions twice a day, and given a massage. The patient will apply the ointment from the beginning of the study, be reevaluated by a physician, and the related questionnaires will be filled out at the end of the first month. To avoid any disruption in the observation and evaluation processes to fill the questionnaires, the primary and final patient’s evaluations will be performed by the same personnaires will be completed. - Control group: in this group, Betamethasone ointment will be applied in the same container; the patients will be examined at the beginning of the study and the end of the first month by a physician, based on the questionnaires. Betamethasone ointment will be given to the patients in the same and uniform containers; it must be applied on lesions twice a day, and given massages. n the lesions and massaged. Erythem. Timepoint: At First and End of One Month. Method of measurement: PASI QUESTIONARE. Scaling. Timepoint: At First and End of One Month. Method of measurement: PASI QUESTIONARE. Induration. Timepoint: At First and End of One Month. Method of measurement: PASI QUESTIONARE. Area. Timepoint: At First and End of One Month. Method of measurement: PASI QUESTIONARE. PASI Score. Timepoint: At First and End of One Month. Method of measurement: PASI QUESTIONARE. QUALITY OF LIFE. Timepoint: FIRST AND ONE MONTH LATER. Method of measurement: DLQ QUESTIONNARE. SATICFACTION. Timepoint: FIRST AND ONE MONTH LATER. Method of measurement: SATISFACTION QUESTION. Iran University of Medical Sciences Approved 2018-08-11 Research Ethics Commitees of Iran University f Medical Sciences Iran University of Medical Science , Hemmat BLV تهران Tehran Iran (Islamic Republic of)