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IRCT20230618058508N1 IRCT 2023-07-02 Tehran University of Medical Sciences Evaluation of the role of oral whey protein with Terminalia Chebula(an Iranian Medicine product) on mild to moderate skin lesion of psoriasis – A Triple-blind randomized controlled trial. Evaluation of the role of oral whey protein with Terminalia Chebula(an Iranian Medicine product) on mild to moderate skin lesion of psoriasis – A Triple-blind randomized controlled trial. 2023-07-23 anticipated 90 Complete https://irct.ir/trial/70768 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization will be done by using random allocation software and creating a table of permutation blocks, which will have 15 blocks of six according to the size of sample and groups, Blinding description: In this project, the pharmaceutical consultant prepares medicine (whey protein and yellow Halila) and placebo (whey protein and starch) in the form of powder in cans of the same shape, weight, and color with specific codes. First, the demographic information is recorded on the form, and then the pocket containing medicine and placebo would be opened and randomly given to people in two groups. It should be noted that all these processes will be carried out by a pharmaceutical consultant and research assistant. In this study, the doctor, the patient and the statistician do not know the contents of the cans. 3 Psoriasis. Intervention 1: Intervention group: They will receive the existing standard treatment of emollient ointment (20% glycerine based on Oserin) and tar shampoo + oral whey protein with terminalia chebula once a day. This group dissolves a full tablespoon (10 grams) of the drug in 1 glass of warm water and drinks it in the morning, about 30 minutes before breakfast. After drinking the medicine, the patient should walk 100 steps. Intervention 2: Control group: They will receive the existing standard treatment of emollient ointment (20% glycerine based on Oserin) and tar shampoo + oral whey protein with starch once a day. This group dissolves a full tablespoon (10 grams) of the placebo in 1 glass of warm water and drinks it in the morning about 30 minutes before breakfast. After drinking the medicine, the patient should walk 100 steps. 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 Undecided - It is not yet known if there will be a plan to make this available
public Nasrin Azhang
No. 27, north sarparast st., western taleghani st., felestin squ.
Tehran Iran (Islamic Republic of) 1111111111 +98 21 8897 4535 nasrinazhang@yahoo.com Tehran University of Medical Sciences scientific Mohammad Hossein Ayati
No. 27, north sarparast st., western taleghani st., felestin squ.
Tehran Iran (Islamic Republic of) ۱۱۱۱۱۱۱۱۱۱ +98 21 8897 4535 Ayatimd@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Age between 18 and 60 Less than 10% of skin involvement Suffering from controlled plaque psoriasis (Unchanged damages in terms of severity and extent in the last 2 months) Not using psoralen in the last 28 days and not receiving UVB in the last 30 days No kidney disease or kidney stones Not being during pregnancy and breastfeeding Not participating in any study in the last month Consent to participate in the study 18 years 60 years Both Suffering from other types of psoriasis, such as pustular, erythrodermic, palmoplantar, psoriatic arthritis Allergy to milk and other dairy product Suffering from kidney stones and kidney disease Using drugs aggravating psoriasis, such as beta-blockers, non-steroidal anti-inflammatory drugs, calcium channel blockers, interleukins, and lithium suffering from uncontrolled cardiovascular, respiratory, hematologic or urinary diseases L40.0 Psoriasis vulgaris Treatment - Drugs Treatment - Drugs Intervention group: They will receive the existing standard treatment of emollient ointment (20% glycerine based on Oserin) and tar shampoo + oral whey protein with terminalia chebula once a day. This group dissolves a full tablespoon (10 grams) of the drug in 1 glass of warm water and drinks it in the morning, about 30 minutes before breakfast. After drinking the medicine, the patient should walk 100 steps. Control group: They will receive the existing standard treatment of emollient ointment (20% glycerine based on Oserin) and tar shampoo + oral whey protein with starch once a day. This group dissolves a full tablespoon (10 grams) of the placebo in 1 glass of warm water and drinks it in the morning about 30 minutes before breakfast. After drinking the medicine, the patient should walk 100 steps. Assessment of disease severity. Timepoint: Before starting the treatment and at the end of weeks 6 and 12. Method of measurement: Using PASI score. Evaluation of the extent of the lesion. Timepoint: Before starting the treatment and at the end of weeks 6 and 12. Method of measurement: Using the BSA index. Assessment of quality of life. Timepoint: It is evaluated before the start of the treatment and at the end of the 12th week. Method of measurement: Using the DLQI index, which is taken from the patient in the form of a questionnaire. Assessment of itching severity. Timepoint: It is evaluated before the start of the treatment and at the end of weeks 6 and 12. Method of measurement: Using the VAS index. Investigation of possible gastrointestinal and skin complications. Timepoint: At the end of weeks 6 and 12. Method of measurement: Using the fifth version of Common Terminology for Adverse Event questionnaire (CTCAE). Tehran University of Medical Sciences Approved 2023-06-11 The Institute of Pharmaceutical Sciences - Tehran University of Medical Sciences 13th floor,A bloc, Simay iran St., between Falamak St. and Zarafshan St., Tehran Tehran Iran (Islamic Republic of)