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IRCT20190202042587N1 IRCT 2019-03-03 Shiraz University of Medical Sciences Evaluation of efficacy of whey protein in contact dermatitis Evaluation of efficacy of whey protein in improving the symptoms of patients with contact dermatitis: A randomized double blind placebo, control clinical trial 2019-03-06 anticipated 60 Complete https://irct.ir/trial/37271 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The study will be blind for patient, outcome assessor and statistical analyzer. Drug and placebo bottles before filling in according to the randomized block table are divided into two equal groups of 30 digits and then, based on the results, bottles are filled with drugs or placebo. The only researcher based on the primary form of the stored results can decode the content of each bottle. None of the responsible person will be aware of the encoding. Results of control and intervention groups under the heading of group A and B delivered to the statistical analyst, Blinding description: Patient, outcome assessor and statistical analyzer. N/A Contact dermatitis. Intervention 1: Intervention group: Patients will receive 30 grams of powder per day, orally, from reputable pharmaceutical companies(half the dose in children) divided into two equal doses. Intervention 2: Control group: Patients will receive 30 grams of placebo per day (half the dose in children), divided into two equal doses, orally.The placebo is made up of 6-1-1 from corn starch, corn flour and lactose which is very similar to Whey in smell and taste and lacks harmful effects. 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 Seyyed Mohammad Hashemi
Namazi Hp.
Shiraz Iran (Islamic Republic of) 7193711351 +98 71 3612 5401 smhashemi5@gmail.com Shiraz University of Medical Sciences scientific Seyyed Mohammad Hashemi
Namazi Hp.
Shiraz Iran (Islamic Republic of) 7193711351 +98 71 3612 5401 smhashemi5@gmail.com Shiraz University of Medical Sciences Iran (Islamic Republic of) Age over 5 years Contact dermatitis(clinical or with patch test) 5 years no limit Both Cows milk allergy Pregnancy or severe disease as malignancy Patients who had a new treatment or an increase in the dose within 4 weeks prior to the intervention Patients treated with immunosuppressive drugs L25 Unspecified contact dermatitis Treatment - Drugs Placebo Intervention group: Patients will receive 30 grams of powder per day, orally, from reputable pharmaceutical companies(half the dose in children) divided into two equal doses. Control group: Patients will receive 30 grams of placebo per day (half the dose in children), divided into two equal doses, orally.The placebo is made up of 6-1-1 from corn starch, corn flour and lactose which is very similar to Whey in smell and taste and lacks harmful effects. Reduced scores in questionnaire and during periodic examination, which indicate better control of the disease and reduced symptoms. Timepoint: At the beginning of the study, 14 and 28 days after starting the drug. Method of measurement: Questionnaire including EASI (eczema area and severity index) and VAS (visual analog scale) and DLQ index (dermatology life quality index). Shiraz University of Medical Sciences Approved 2018-12-19 Ethics committee of Shiraz University of Medical Sciences Zand Blvd.,Shiraz University of Medical Sciences Shiraz Fars Iran (Islamic Republic of)