Protocol summary

Study aim
Determining the effect of Barhang ointment on atopic dermatitis in patients referred to the dermatology clinics of Javad Al-A'meh Clinic in 1401
Design
Clinical trial with control group with parallel groups, double-blind, randomized by quadruple block method, phase 3 on 48 patients
Settings and conduct
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 based on randomization of quadruple block and those receiving deciduous ointment and those receiving placebo, so that the number of patients with atopic dermatitis is the same in both groups. The intervention is performed for 2 months before and after the course. scorad are compared for response to treatment The two-way blind method is used to blind the participant, researcher, clinical caregiver, outcome assessor and data analyst.
Participants/Inclusion and exclusion criteria
Patients with atopic dermatitis Admission according to scorad criteria, mild to moderate dermatitis, poor response to routine treatment, absence of infection, written consent Failure to enter in case of receiving oral or injectable steroids, symptoms of intolerance, presence of disease that reduces drug absorption, lack of regular participation
Intervention groups
Barhang ointment receiving group Placebo group
Main outcome variables
Erythema, dryness, edema, discharge, thickening, itchy skin

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200304046695N1
Registration date: 2022-07-01, 1401/04/10
Registration timing: prospective

Last update: 2022-07-01, 1401/04/10
Update count: 0
Registration date
2022-07-01, 1401/04/10
Registrant information
Name
Zohreh Zandvakil
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3222 9776
Email address
zandvakilz@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-07-23, 1401/05/01
Expected recruitment end date
2023-01-21, 1401/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of plantago ointment on improving the symptoms of patients with atopic dermatitis
Public title
The effect of plantago ointment on atopic dermatitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
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
Exclusion criteria:
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
Age
From 18 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 48
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Double blinded
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.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Kerman University of Medical Sciences
Street address
Kerman University of Medical Sciences, Medical University Campus, Haft-Bagh Highway, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7616913555
Approval date
2020-02-17, 1398/11/28
Ethics committee reference number
IR.Kmu.REC.1398.639

Health conditions studied

1

Description of health condition studied
Dermatit Atopic
ICD-10 code
L20
ICD-10 code description
Atopic dermatitis

Primary outcomes

1

Description
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

2

Description
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

3

Description
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

4

Description
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

5

Description
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

6

Description
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

Secondary outcomes

empty

Intervention groups

1

Description
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.
Category
Treatment - Drugs

2

Description
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.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Javad Al-A'meh Specialized Medical Complex
Full name of responsible person
Zohreh Zandvakil
Street address
Kerman, Abuzarshamali St., Alley No. 25, Javadalaimeh Medical Complex
City
Kerman
Province
Kerman
Postal code
7617763811
Phone
+98 34 3251 2098
Email
zandvakilz@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Dr. Reza Malekpour Afshar
Street address
Ebn-e-Sina St., Jahad Blvd., Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3226 3855
Email
Zandvakilz@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Zohreh Zandvakil
Position
Intern
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Kerman University of Medical Sciences, Medical University Campus, Haft-Bagh Highway, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5700
Email
Zandvakilz@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Zohreh Zandvakil
Position
Intern
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Kerman University of Medical Sciences, Medical University Campus, Haft-Bagh Highway, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5700
Email
Zandvakilz@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Zohreh Zandvakil
Position
Intern
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Kerman University of Medical Sciences, Medical University Campus, Haft-Bagh Highway, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5700
Email
Zandvakilz@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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