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IRCT20170930036486N2 IRCT 2018-05-17 Babol University of Medical Sciences Investigating the effect of Sambucus ebulus on hand eczema Comparison between the efficacy of topical product of Sambucus ebulus and Hydrocortisone on the clinical severity of patients with hand eczema 2018-05-22 anticipated 72 Complete https://irct.ir/trial/29168 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block randomization: At first, blocks containing 4 of two treatments (Sambucus ebulus or Hydrocortisone) are written with different possible combinations, each given a number, and then using the random number table, each of the 4 blocks, one Of these compounds is devoted, Blinding description: The form of the drug in the same tubes is provided by the pharmacologist. The smell of drugs is largely similar. The researcher does not know the content of the tubes and only the biostatistician knows about it. Patients are also unaware of the contents of the tubes.The conscientious consent will be given to patients and will be explained to them that there are two groups in this study : case and control and they will be in one of these groups by randomization. 3 Hand eczema. Intervention 1: Intervention group:Topical product of sambucus ebulus،one gram،twice a day،six weeks.After the forth weeks، we will give them 20 jujubes،every day for two weeks.They should boil them in the 4 glasses of water and after boiling ، 3 glasses of water will be remained.They will drink every 8 hours ، one glass of this water. Intervention 2: Control group:Hydrocortisone cream،one gram،twice a day،six weeks.After the forth weeks، we will give them 20 jujubes،every day for two weeks.They should boil them in the 4 glasses of water and after boiling ، 3 glasses of water will be remained.They will drink every 8 hours ، one glass of this water. 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 Akram moradi farahani
Gang Afrooz street
Babol Iran (Islamic Republic of) 47176-47745 +98 11 3219 4730 a.moradi@mubabol.ac.ir Babol University of Medical Sciences scientific Seyyed Ali Mozaffarpur
Gang Afrooz street
Babol Iran (Islamic Republic of) 47176-47745 +98 11 3219 4730 seyyedali1357@gmail.com Babol University of Medical Sciences Iran (Islamic Republic of) Age 18 to 60 years Patients with hands eczema who have not received any topical medication from the 14 days prior to study 18 years 60 years Both Pregnant mothers Nursing mothers The presence of underlying diseases of the kidney, liver, heart, diabetes, History of drug allergy Patients with obsessive-compulsive disorder or other mental illness that interferes with the study Use of Systemic Corticosteroids or Immunosupressives over the past 4 weeks Localized infection in the place of eczema L20-L30 Dermatitis and eczema Treatment - Drugs Treatment - Drugs Intervention group:Topical product of sambucus ebulus،one gram،twice a day،six weeks.After the forth weeks، we will give them 20 jujubes،every day for two weeks.They should boil them in the 4 glasses of water and after boiling ، 3 glasses of water will be remained.They will drink every 8 hours ، one glass of this water. Control group:Hydrocortisone cream،one gram،twice a day،six weeks.After the forth weeks، we will give them 20 jujubes،every day for two weeks.They should boil them in the 4 glasses of water and after boiling ، 3 glasses of water will be remained.They will drink every 8 hours ، one glass of this water. Severity of hand eczema. Timepoint: Before the intervention begins، 14، 28، 42th day after starting of treatment. Method of measurement: Hand eczema severity index. Dermatology Life Quality Index. Timepoint: Before the intervention begins، 14، 28، 42th day after starting of treatment. Method of measurement: Dermatology Life Quality Index questionnaire. Rate of healing. Timepoint: Before the intervention begins، 14، 28، 42th day after starting of treatment. Method of measurement: Hand eczema severity index. Babol University of Medical Sciences Approved 2017-11-18 Ethics committee ofBabol University of Medical Sciences Gang Afrooz street Babol Mazandaran Iran (Islamic Republic of)