Properties of patented topical formula containing extract of Malva Sylvesteris according to pharmacognostic formulated standards will be compared with Oserin demulcent in improvement of signs of erythema, edema, excoriation and lichenification in mild to moderate atopic dermatitis
Design
A double blind randomized clinical trial will be performed
Settings and conduct
This clinical trial will be performed with two 22 persons groups after explanation the procedure for patients and filling out consent forms by them and then intervention group will use a finger tip of patented herbal topical formulation of Malva Sylvesteris for one hand of affected body surface twice daily and in return investigation group use Oserin ointment in the same way
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients with mild to moderate atopic dermatitis lesions in aged between six months to 12 years old
Exclusion criteria: Psoriasis; patients with allergic reactions to Malva Sylvesteris; history of oral corticosteroid or antihistamine consumption in the last week or topical steroid in the last 3 weeks
Intervention groups
22 persons who take Malva Sylvesteris ointments
Main outcome variables
Improvement of sings and symptoms of mild to moderate atopic dermatitis lesions
General information
Reason for update
Acronym
Not
IRCT registration information
IRCT registration number:IRCT20170107031814N2
Registration date:2018-05-11, 1397/02/21
Registration timing:prospective
Last update:2018-05-11, 1397/02/21
Update count:0
Registration date
2018-05-11, 1397/02/21
Registrant information
Name
Mahshid Meyssami
Name of organization / entity
Shahid Sadoughei Univercity Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 35 3724 0171
Email address
m.meyssami@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research,Shahid Sadoughei University of Medical Saciences
Expected recruitment start date
2018-05-22, 1397/03/01
Expected recruitment end date
2018-08-23, 1397/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effectiveness of Malva Sylvesteris ointment with Oserin demulcent in treatment of atopic dermatitis in 6 months to 12 years old groups
Public title
Eٍٍffect of Malva Sylvesteris oitment in treatment of atopic eczema
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
َAll patients with mild to moderate atopic dermatitis lesions
All patient with mild to moderate atopic dermatitis lesions aged between 6 months to 12 years old
Exclusion criteria:
Psoriasis
Patients with Allergic Reactions to Malva Sylvesteris
History of corticosteroid or antihistamine consumption in the last week or use of topical steroid in the last three weeks in all patients
Age
From 6 months old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
44
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
By dividing patients in two groups A and B
Group A received Malva Sylvesteris ointment in a tube without label and group B received placebo in a similar color as group A
Placebo
Used
Assignment
Parallel
Other design features
Not
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Yazd University of Medical Sciences
Street address
Centeral Departement of Shahid Sadoughi Medical University, Shahid Bahonar square
City
Yazd
Province
Yazd
Postal code
8916978477
Approval date
2016-12-26, 1395/10/06
Ethics committee reference number
IR.SSU.REC.1395.196
Health conditions studied
1
Description of health condition studied
Atopic dermatitis
ICD-10 code
L20-L20.0-
ICD-10 code description
Atopic dermatitis; Besnier prurigo; other atopic dermatitis; atopic dermatitis unspecified
Primary outcomes
1
Description
Time for improvement of signs of atopic dermatitis lesions
Timepoint
In first physical examination then after one week then every other week until six weeks
Method of measurement
By taking pictures and filling out the forms
Secondary outcomes
1
Description
Allergy to applied treatment or Infection
Timepoint
During treatment
Method of measurement
Visit by expert physician
Intervention groups
1
Description
Intervention group: Use of a fingertip of patented herbal topical formulation of MalvaSylvesteris extract for one hand of affected body surface with atopic dermatitis lesions twice daily and following the improvement of signs of dermatitis lesions after one week and then every other week until six weeks
Category
Treatment - Drugs
2
Description
Control group: Use of a fingertip of Oserin ointment for one hand of affected body surface with atopic dermatitis lesions twice daily and following the improvement of signs of dermatitis lesions after one week and then every other week until six weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Comprehensive Health Centers in Yazd, Yazd Health Network, Khatamolanbia Clinic
Full name of responsible person
Mahshid Meyssami
Street address
Central Department of Shahid Sadoughi, Medical University, Shahid Bahonar square
City
Yazd
Province
Yazd
Postal code
8916978477
Phone
+98 35 3724 0171
Email
m.meyssami@ssu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr. A.H. Mehrparvar
Street address
Centeral Building of Shahid Sadoughi Medical University ,Shahid Bahonar Square
City
Yazd
Province
Yazd
Postal code
8916978477
Phone
+98 35 3724 0171
Email
m.meyssami@ssu.ac.ir
Grant name
---
Grant code / Reference number
----
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd 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
Yazd University of Medical Sciences
Full name of responsible person
Mahshid Meyssami
Position
PHD candidate
Latest degree
Medical doctor
Other areas of specialty/work
Street address
Ardakan Imam Khomeini Avenue
City
Ardakan
Province
Yazd
Postal code
8916978477
Phone
+98 32238915
Fax
Email
m.meyssami@ssu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr. Majid Emtiazy
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Traditional Medicine
Street address
Traditional Medicine faculty/ Imam Khomeini aveniue
City
Ardakan
Province
Yazd
Postal code
8916978477
Phone
+98 32238915
Fax
Email
Dr.emtiazy@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Meyssami Mahshid
Position
Phd Canditate
Latest degree
Medical doctor
Other areas of specialty/work
Street address
Imam Khomeini aveniue/ Traditional Medicine faculty of Ardakan
City
Ardakan
Province
Yazd
Postal code
8916978477
Phone
+98 32238915
Fax
Email
m.meyssami@ssu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD