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IRCT20140212016557N8 IRCT 2021-10-03 Shiraz University of Medical Sciences Effect of oral probiotic in the treatment of psoriasis Comparison of the effect of oral administration of probiotic strains with placebo on the clinical severity of psoriasis vulgaris 2021-10-23 anticipated 60 Complete https://irct.ir/trial/59050 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The participants were randomized using permuted block randomization (size of each block: 4), in individual units, using random allocation software. The output of software is a table that determines the patient receives probiotic or placebo, Blinding description: Probiotic and placebo are packed in the similar packages and are numbered according the patients' codes. Investigator and care provider are aware of the types pf drugs. But, data collectors and outcome assessors are not aware of the medication of each patient. 3 psoriasis. Intervention 1: Intervention group: Daily consumption of Lactocare probiotic capsules (Zist takhmir company, Tehran, Iran), the once daily application of mometasone ointment on skin lesions and mometasone lotion on the scalp lesions for 3 months. Intervention 2: Control group: Daily consumption of placebo capsules containing starch, once daily application of mometasone ointment on skin lesions and mometasone lotion on the scalp lesions for 3 months. 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 Possibility of loss of confidentiality
public Amir Nasiri
Shiraz University of Medical Sciences, Zand St., Shiraz, Iran
Shiraz Iran (Islamic Republic of) 7134844119 +98 71 3212 5239 amir_nasiri68@yahoo.com Shiraz University of Medical Sciences scientific Mozhdeh Sepaskhah
Shiraz University of Medical Sciences, Zand St., Shiraz, Iran
Shiraz Iran (Islamic Republic of) 7134844119 +98 71 3212 5239 sepaskhah@sums.ac.ir Shiraz University of Medical Sciences Iran (Islamic Republic of) Plaque type psoriasis 18 years of age or older Involvement of 20% or less of body surface area 18 years no limit Both Severe scalp psoriasis Worsening of signs and symptoms of psoriasis during treatment Pregnancy Lactation Consumption of any systemic treatment affecting psoriasis within the last three months before recruiting in the study Antibiotic administration within the recent two weeks Any signs and symptoms of bacterial infections Concomitant skin diseases Presence of significant liver diseases Presence of significant chronic kidney diseases Consumption of probiotic-containing products (including probiotic-containing foods) L40.0 psoriasis vulgaris Treatment - Drugs Treatment - Drugs Intervention group: Daily consumption of Lactocare probiotic capsules (Zist takhmir company, Tehran, Iran), the once daily application of mometasone ointment on skin lesions and mometasone lotion on the scalp lesions for 3 months Control group: Daily consumption of placebo capsules containing starch, once daily application of mometasone ointment on skin lesions and mometasone lotion on the scalp lesions for 3 months Quantitative score of the clinical severity of psoriasis. Timepoint: At the beginning of treatment, months 1, 2, and 3 after treatment. Method of measurement: Psoriasis Area Severity Index (PASI) score. Qualitative clinical severity of psoriasis. Timepoint: Months 1, 2, and 3 after treatment. Method of measurement: Physician global assessment score. Quality of life. Timepoint: At the beginning and end of treatment. Method of measurement: Dermatology quality of life index questionnaire. Percentage of acceptable improvement. Timepoint: Months 1, 2, and 3 after treatment. Method of measurement: Percentage of people who achieve equal to or more than ۷۵% reduction in Psoriasis Area Severity Score. Rate of improvement. Timepoint: Months 1, 2, and 3 after treatment. Method of measurement: Time of achievement of equal to or more than ۷۵% reduction in Psoriasis Area Severity Score. Shiraz University of Medical Sciences Approved 2021-09-08 Ethics committee of Shiraz University of Medical Sciences Shiraz University of Medical Sciences, Zand St., Shiraz. Iran Shiraz Fars Iran (Islamic Republic of)