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IRCT20200304046695N1 IRCT 2022-07-01 Kerman University of Medical Sciences The effect of plantago ointment on atopic dermatitis The effect of plantago ointment on improving the symptoms of patients with atopic dermatitis 2022-07-23 anticipated 48 Complete https://irct.ir/trial/48408 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: This study is a double-blind clinical trial that is conducted on patients with eczema in patients referred to Javad Al-A'meh Clinic in Kerman in 1401. Patients are randomly divided into two groups of drugs and placebo. Randomization is designed using the method of block size four by a statistician with the Allocation Random software as (BAAB), (ABBA), (AABB), (BBAB), (ABAB)…. 48 envelopes (24 envelopes containing paper A for drug group) and (24 envelopes containing paper B for placebo group) are prepared and given to a trained person outside the research team (nurse) who is responsible for randomly assigning patients based on the method of block size four. The random allocation will be done consecutively until the sampling is completed, Blinding description: Patients with atopic dermatitis referred to dermatology clinics in Kerman are diagnosed based on scorad criteria and are included in the study based on the criteria for entering and obtaining informed consent. Patients are divided into two groups receiving barhang ointment and receiving medication based on the randomization method of quadruple block, so that the number of patients with atopic dermatitis is the same in both groups.And this is done by someone other than the researcher, who does not know what group the person belongs to The drug and the placebo are made by the pharmacist and are similar in shape, color and smell and are coded and the patient and the researcher do not know the type of drug. 3 Dermatit Atopic. Intervention 1: Intervention group:First, the flowering plant is collected from Kerman Baft farms and after approval by a botanist, a herbarium sample is prepared. The collected plant is then dried in the shade. Then it is ground and passed through a mesh sieve 40. 100 g of the plant is boiled and filtered with 500 ml of water for 10 minutes and the extract is boiled until it is concentrated and dried in an oven at 50 ° C. To prepare the ointment, 5% of the leaf extract is added, 5 g of the extract dried by a thoroughly mortar mortar, 10 ml of glycerin and 85 g of osrine. Intervention 2: Control group:The placebo is prepared using 10 ml of glycerin and 85 g of oserin without adding turmeric extract. Oral brown dye is used to color the placebo with the main drug. 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 Don't find
public Zohreh Zandvakil
Kerman University of Medical Sciences, Medical University Campus, Haft-Bagh Highway, Kerman, Iran
Kerman Iran (Islamic Republic of) 7616913555 +98 34 3132 5700 Zandvakilz@gmail.com Kerman University of Medical Sciences scientific Zohreh Zandvakil
Kerman University of Medical Sciences, Medical University Campus, Haft-Bagh Highway, Kerman, Iran
Kerman Iran (Islamic Republic of) 7616913555 +98 34 3132 5700 Zandvakilz@gmail.com Kerman University of Medical Sciences Iran (Islamic Republic of) Approval of Hanifin and Rajka criteria for atopic dermatitis Mild to moderate atopic dermatitis (SCORAD <50) Poor response to conventional therapies (topical steroids and antihistamines) Absence of exudate or infection Concomitant presence of systemic disease or dermatitis except atopic dermatitis Written and informed consent of the patient 18 years 70 years Both Taking oral or injectable steroids, antibiotics, phototherapy, and other immunosuppressive treatments (such as cyclosporine and azathioprine) but the corticosteroid position is not contraindicated. Day Symptoms of drug intolerance such as severe heartburn and bloating Existence of diseases that interfere with drug absorption, such as inflammatory bowel disease Inability to participate regularly in follow-up L20 Atopic dermatitis Treatment - Drugs Placebo Intervention group:First, the flowering plant is collected from Kerman Baft farms and after approval by a botanist, a herbarium sample is prepared. The collected plant is then dried in the shade. Then it is ground and passed through a mesh sieve 40. 100 g of the plant is boiled and filtered with 500 ml of water for 10 minutes and the extract is boiled until it is concentrated and dried in an oven at 50 ° C. To prepare the ointment, 5% of the leaf extract is added, 5 g of the extract dried by a thoroughly mortar mortar, 10 ml of glycerin and 85 g of osrine. Control group:The placebo is prepared using 10 ml of glycerin and 85 g of oserin without adding turmeric extract. Oral brown dye is used to color the placebo with the main drug. Skin erythema. Timepoint: Before the intervention, 2 months after taking the drug, 15 days after the end of the course. Method of measurement: Based on scorad criteria. Skin dryness. Timepoint: Before the intervention, 2 months after taking the drug, 15 days after the end of the course. Method of measurement: Based on scorad criteria. Skin edema. Timepoint: Before the intervention, 2 months after taking the drug, 15 days after the end of the course. Method of measurement: Based on scorad criteria. Skin itching. Timepoint: Before the intervention, 2 months after taking the drug, 15 days after the end of the course. Method of measurement: Based on scorad criteria. Skin discharge. Timepoint: Before the intervention, 2 months after taking the drug, 15 days after the end of the course. Method of measurement: Based on scorad criteria. Thickening of the skin. Timepoint: Before the intervention, 2 months after taking the drug, 15 days after the end of the course. Method of measurement: Based on scorad criteria. Kerman University of Medical Sciences Approved 2020-02-17 Ethics committee of Kerman University of Medical Sciences Kerman University of Medical Sciences, Medical University Campus, Haft-Bagh Highway, Kerman, Iran Kerman Kerman Iran (Islamic Republic of)