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IRCT20180804040694N1 IRCT 2018-12-31 Tehran University of Medical Sciences "Effect of Boswellia in psoriasis" Effect of a topical Boswellia-based cream (Persian Medicine product) on skin manifestations and quality of life in mild to moderate plaque psoriasis 2018-12-22 anticipated 108 Complete https://irct.ir/trial/35435 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, randomly permuted blocks of size 6 are used to assign participants into two groups (treatment and placebo groups). There are 108 participants in this study and as a result, 18 blocks of size 6 is considered. With blocks of size six, for example the order in which the integers 1,2,3,4, 5, 6 appear in a random permutation determines which patients receive the treatment (those whose numbers appear first, second and third) and which receive the placebo (those whose numbers appear fourth, fifth and sixth). For example, if numbers appear in the order of 4, 1, 6, 3, 2 and 5, the assignment of participants to the study groups will be as follows: Placebo, Treatment, Placebo, Treatment, Treatment, and Placebo. This procedure will be performed to obtain all 18 blocks of size six (1). Fleiss JL. Design and analysis of clinical experiments: John Wiley & Sons; 2011, Blinding description: Participant, physician, clinical care, researcher and outcomes evaluation are blind in this study .According to the drug and placebo are similar in appearance, color, weight, smell, and manner of use. 3 Plaque Psoriasis. Intervention 1: Intervention group: The patients use 1gr of topical Frankincense based cream on the skin lesion twice a day for a period of four weeks (28 days). Measure of topical medication is Finger Tip Unit (FTU). Intervention 2: Control group: The patients consumed 1 gr of the same cream in consistency, odor, and color without combining Frankincense on the skin lesion twice a day for a four-week period (28 days). Yes - There is a plan to make this available What will be shared: Skin lesions and quality of life database will be share in patients with mild to moderate psoriasis. When: " The results will be available 6 months after printing" To whom: Researchers working in academic and scientific institutions and those involved in the pharmaceutical industry. Conditions: They make the low risk drug. Where to obtain: Fateme Fadaei , The University of Tehran, Ahmadiyyeh Persian Medicine Clinic. f-fadaei@razi.tums.ac.ir How to obtain: First, they will send an application to Mrs. Dr. Shirbeigi, then they will have access to the documentations after review for 6 months, if agreed necessary. l.shirbeigi@yahoo.com Comments:
public Fateme Fadaei
No. 20, 4h Laleh St., Shaghayegh Blvd., Saadat Abad
Tehran Iran (Islamic Republic of) 19818443631 +98 21 2234 6099 f-fadaei@razi.tums.ac.ir Tehran University of Medical Sciences scientific Fateme Fadaei
No. 20, 4th Laleh St., Shaghayegh Blvd., Saadat Abad
Tehran Iran (Islamic Republic of) 1981843631 +98 21 2234 6099 f-fadaei@razi.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Diagnosed with clinical of mild to moderate Plaque Psoriasis Age between 18-70 years old PASI score <12 Involvement of body surface area <10% Written informed consent 18 years 70 years Both Gguttate, erythrodernic, psoriatic arthritis or pustular psoriasis at the time of screening; psoriasis vulgaris patients with face involvement only; Known allergic or hypersensitive reactions to cream components; Using medications that could trigger psoriasis like beta blockers, antimalarials, terbinafine, calcium channel blockers, interleukins and lithium; Previous treatment with systemic corticosteroids, biologic and immunosuppression drugs or psoralen ultraviolet A therapy within the previous four weeks; Previous treatment with local corticosteroids within the previous two weeks; Presence of skin infections or malignancy in the treatment area; Severe psoriasis; Patients who require systemically acting medications for the treatment of psoriasis; Pregnant or breast-feeding females; L40.0 Plaque psoriasis Treatment - Drugs Placebo Intervention group: The patients use 1gr of topical Frankincense based cream on the skin lesion twice a day for a period of four weeks (28 days). Measure of topical medication is Finger Tip Unit (FTU) Control group: The patients consumed 1 gr of the same cream in consistency, odor, and color without combining Frankincense on the skin lesion twice a day for a four-week period (28 days). The Psoriasis Area Severity Index (PASI);. Timepoint: PASI score is evaluated at baseline, day 14 and day 28;. Method of measurement: Fotofinder device;. Physician Global Assessment (PGA score);. Timepoint: Outcoms are evaluated at baseline, day 14 and day 28;. Method of measurement: Physician's observation;. The body surface area (BSA);. Timepoint: Outcoms are evaluated at baseline, day 14 and day 28;. Method of measurement: Palm method (patient's handprint);. Assess pruritus intensity;. Timepoint: Outcoms are evaluated at baseline, day 14 and day 28;. Method of measurement: The VAS (visual analoge scale) is used. It is a criterion 10 grades are used and the patient shows the quality in quantitative form with the number;. The DLQI (dermatology life and quality index) of the psoriasis patients;. Timepoint: Outcoms are evaluated at baseline, day 14 and day 28;. Method of measurement: Questionnaire;. Photo of Plaque Psoriasis. Timepoint: Outcoms are evaluated at baseline, day 14 and day 28;. Method of measurement: Camera;. Patient's satisfaction;. Timepoint: Outcoms are evaluated at day 14 and day 28;. Method of measurement: The VAS (visual analoge scale) is used. It is a criterion 10 grades are used and the patient shows the quality in quantitative form with the number;. Adverse events of the drug;. Timepoint: Outcoms are evaluated at day 14 and day 28;. Method of measurement: Questionnaire;. Tehran University of Medical Sciences Approved 2018-10-29 Ethics committee of Tehran University of Medical Science 13th Floor, Block A, Headquarters of Ministry of Health and Medical Education, Sima-ye Iran St.,Farahzadi Blvd., Qods Town Tehran Tehran Iran (Islamic Republic of)