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IRCT20250428065504N1 IRCT 2025-07-11 Gorgan University of Medical Sciences Evaluating the effectiveness of a topical herbal product (Myrtus communis L., Lawsonia inermis L., Ziziphus spina-christi) compared to a topical betamethasone ointment on hand eczema Evaluating the effectiveness of a topical herbal product (Myrtus communis L., Lawsonia inermis L., Ziziphus spina-christi) compared to a topical betamethasone ointment on the severity of clinical symptoms in patients with hand eczema: A randomized controlled clinical trial 2025-06-22 anticipated 88 Complete https://irct.ir/trial/83626 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: People who meet the entry criteria and do not meet the non-entry criteria and agree to participate in the study will be randomly assigned to one of two treatment groups based on block-of-four allocation. These blocks have 2 letters, A and B, and each letter has two repetitions. The number of blocks of 4 is equal to 22, whose sequence is produced by R software, Blinding description: Study ointments are similar to the extent that is technically possible, and the tubes of herbal ointment and cortisone are identical and have A or B labels. The participants are randomly placed in one of the two groups receiving medicine A or B. The researcher, the participant and the medical personnel who provide the medicine to the patient do not know the content of ointment A or B. Also, the data in two groups A and B will be collected and provided to the statistician for analysis. 3 Hand eczema. Intervention 1: Intervention group: Herbal topical product (Myrtus communis L., Lawsonia inermis L., Ziziphus spina-christi) with a concentration of 1.5%, once a night at the site of eczema. Made by Niak Pharmaceutical Company. Intervention 2: Control group: Topical betamethasone ointment 0.1%, once a night in the eczema site. Manufactured by Niak Pharmaceutical Company. 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 further information available.
public Faegheh Hasanzadeh
4th Floor ,Diamond Building 2, 103/2 Edalat Alley, Blvd.
Gorgan Iran (Islamic Republic of) 4917914914 +98 17 3255 6152 dr.hasanzadeh@goums.ac.ir Gorgan University of Medical Sciences scientific Faegheh Hasanzadeh
4th Floor,Diamond Building 2,103/2 Edalat Alley,Naharkhoran Blvd., Gorgan
Gorgan Iran (Islamic Republic of) 4917914914 +98 17 3255 6152 dr.hasanzadeh@goums.ac.ir Gorgan University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Patients aged 18-60 years Patients with hand eczema with mild involvement need treatment or moderate Patients with hand eczema who have not received any topical medication for 14 days prior to the study Patients who consent to participate in the study. 18 years 60 years Both Having another skin disease Presence of end-stage underlying liver or kidney disease Pregnant and lactating mothers Use of systemic corticosteroids or immunosuppressants within the last 8 weeks Local infection at the site of eczema L23.9 Allergic contact dermatitis, unspecified cause Treatment - Drugs Treatment - Drugs Intervention group: Herbal topical product (Myrtus communis L., Lawsonia inermis L., Ziziphus spina-christi) with a concentration of 1.5%, once a night at the site of eczema. Made by Niak Pharmaceutical Company. Control group: Topical betamethasone ointment 0.1%, once a night in the eczema site. Manufactured by Niak Pharmaceutical Company. Itching severity. Timepoint: At the beginning of the study and one month after the start of treatment. Method of measurement: Visual Analog Scale. Erythema. Timepoint: At the beginning of the study and one month after the start of treatment. Method of measurement: Hand Eczema Severity Index(HECSI). Irritation. Timepoint: At the beginning of the study and one month after the start of treatment. Method of measurement: Visual Analog Scale(VAS). Dryness, cracking, and peeling skin. Timepoint: At the beginning of the study and one month after the start of treatment. Method of measurement: Hand Eczema Severity Index. Papule. Timepoint: At the beginning of the study and one month after the start of treatment. Method of measurement: Hand Eczema Severity Index. Quality of life. Timepoint: At the beginning of the study and one month after the start of treatment. Method of measurement: Dermatology Life Quality Index. Gorgan University of Medical Sciences Approved 2025-03-09 Ethics committee of Golestan University of Medical Sciences No. 4, Diamond 2 Building,103/2 Edalat Alley,Naharkhoran Blvd Gorgan Golestan Iran (Islamic Republic of)