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
To determine the effectiveness of a topical herbal product compared to topical betamethasone ointment on the severity of clinical symptoms in patients with hand eczema.
Design
Randomized, controlled, parallel, double-blind ,phase 3 clinical trial on 88 patients . Randomized block assignment of four by R software.
Settings and conduct
Patients of educational and therapeutic centers in Gorgan who have hand eczema;
Its severity is determined by dermatologist's clinical opinion and Hand Eczema Severity Index (HECSI) ;
First, a checklist including demographic information and past disease history and medical history;
Then matching the inclusion and exclusion criteria, and completing a written and informed consent;
Then a description of the current disease and clinical symptoms, a quality of life questionnaire, a Mizaj questionnaire;
Then random assignment to two groups؛
Then giving a pack of lifestyle recommendations, emollient cream, and glycerin soap to all participants; And ointment A or B
Follow-up of the patient's condition and possible complications during the implementation of the project;
Visits are one month and six weeks after the start
Participants/Inclusion and exclusion criteria
Inclusion: Patients aged 18-60 years, with moderate or mild hand eczema requiring treatment, who had not received any topical medication for 14 days prior to the study; Patients who consented to participate in the study.
Exclusion: Other skin disease؛ Pregnant and lactating mothers؛ End-stage renal or hepatic disease؛ Use of systemic corticosteroids or immunosuppressants within the last 8 weeks؛ Local infection at the site of 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
Public title
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
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
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.
Exclusion criteria:
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
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
88
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Double blinded
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.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Golestan University of Medical Sciences
At the beginning of the study and one month after the start of treatment
Method of measurement
Visual Analog Scale
2
Description
Erythema
Timepoint
At the beginning of the study and one month after the start of treatment
Method of measurement
Hand Eczema Severity Index(HECSI)
3
Description
Irritation
Timepoint
At the beginning of the study and one month after the start of treatment
Method of measurement
Visual Analog Scale(VAS)
4
Description
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
5
Description
Papule
Timepoint
At the beginning of the study and one month after the start of treatment
Method of measurement
Hand Eczema Severity Index
Secondary outcomes
1
Description
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
Intervention groups
1
Description
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.
Category
Treatment - Drugs
2
Description
Control group: Topical betamethasone ointment 0.1%, once a night in the eczema site. Manufactured by Niak Pharmaceutical Company.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Deziani Specialized and Subspecialty Clinic
Full name of responsible person
Ali Rezaee nejad
Street address
Deziani Specialized and Subspecialty Clinic, Opposite Behesht 17, Shahid Beheshti Street