Atopic dermatitis is a chronic and recurrent skin disorder which is associated with itchy rashes. Patients suffering with allergic reactions are more likely to be affected by this condition. The causes of this disease probably are genetic factors, immune system deficiency and presence of damaged skin barrier.
Atopic dermatitis is treated with the wide ranges of oral and topical medications; however, major side effects are associated with these current agents.
Based on several studies, Curcuma Longa can inhibit several inflammatory enzymes mainly involved in the inflammatory process of atopic dermatitis. Therefore, we have decided to target and use this well known herbal agent with fantastic safety as a novel topical formulation.
The clinical and therapeutic benefit of this novel topical formulation was carried out on 40 patients with mild to moderate atopic dermatitis in a double-blind, placebo-controlled clinical trial. patients were instructed to apply the 5 % tumeric extract in microemulgel twice a day. Patients in control group applied microemulgel without tumeric extract. Erythema, dryness, burning, itching and other side effects evaluated using the quality of Life questionnaire and SCORAD as well as photos before and after treatment.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201503163106N23
Registration date:2015-04-22, 1394/02/02
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-04-22, 1394/02/02
Registrant information
Name
Farshad Hashemian
Name of organization / entity
Pharmaceutical Sciences Branch, Islamic Azad University (IAU)
Country
Iran (Islamic Republic of)
Phone
+98 21 2260 0037
Email address
hashemian.f@iaups.ac.ir
Recruitment status
Recruitment complete
Funding source
1- Pharmaceutical Sciences branch of Islamic Azad University, 2- investigators financial sources
Expected recruitment start date
2013-10-22, 1392/07/30
Expected recruitment end date
2014-10-22, 1393/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of hydro- alcoholic total extract of turmeric rhizomes on eczema
Public title
The effect of extract turmeric on eczema
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age over 18 years old; both sexes; absence of infection or skin cancer; patients with mild & moderate plaque eczema which had been stable on systemic treatment for at least 2 month; wash out period for topical anti eczema agent at least 2 weeks before clinical trial.
Exclusion criteria: pregnancy; lactation; age under 18 years old; a history of sensitivity to the active ingredient or expedients; patient decision to leave the study.
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Pharmaceutical science branch of Islamic Azad
Street address
No.99, Yakhchal street, Dr. Shariati Avenue
City
Tehran
Postal code
00982161192655
Approval date
2013-09-01, 1392/06/10
Ethics committee reference number
6563
Health conditions studied
1
Description of health condition studied
Atopic dermatitis
ICD-10 code
L20.0
ICD-10 code description
Besnier's prurigo
Primary outcomes
1
Description
Erythema
Timepoint
at the baseline, every 3 weeks up to 12 weeks
Method of measurement
photography: before,during &after treatment and questionnair of life of quality and scorad
2
Description
dryness
Timepoint
at the baseline, every 3 weeks up to 12 weeks
Method of measurement
photography: before,during &after treatment and questionnair of life of quality and scorad
3
Description
burning
Timepoint
at the baseline, every 3 weeks up to 12 weeks
Method of measurement
questionnair
4
Description
itching
Timepoint
at the baseline, every 3 weeks up to 12 weeks
Method of measurement
questionnair
Secondary outcomes
1
Description
side effects
Timepoint
at the baseline, every 3 weeks up to 12 weeks
Method of measurement
Questionnaire
Intervention groups
1
Description
Intervention group: 5 % tumeric extract in microemulgel. patients were instructed to apply the Herbal microemulgel twice a day
Category
Treatment - Drugs
2
Description
Control group: microemulgel without tumeric extract. patients were instructed to apply twice a day.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam khomaini hospital
Full name of responsible person
Dr. Parvin Mansouri
Street address
Imam Khomeini Hospial complex, Keshavarz blvd.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic azad university of pharmaceutical sciense
Full name of responsible person
Dr. Sepideh Arbabi Bigdeli
Street address
No.99, Yakhchal street, Dr. Shariati Avenue Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic azad university of pharmaceutical sciense
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Person responsible for scientific inquiries
Contact
Name of organization / entity
Pharmaceutical science branch of Islamic Azad university
Full name of responsible person
Dr. Mehdi Rajabi
Position
Assistant professor / Head of Department
Other areas of specialty/work
Street address
No.99, Yakhchal street, Dr. Shariati Avenue
City
Tehran
Postal code
Phone
+98 21 2246 0056
Fax
Email
mehdirj@aol.co.uk
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)