1- Determining the severity of symptoms in patients with eczema after consuming lavender essential oil in doses of 1.4 and 8%
2- Determining the severity of symptoms in patients with psoriasis after consuming lavender essential oil in doses of 1.4 and 8%
3- Determining the severity of symptoms in patients with psoriasis after consuming peppermint essential oil in doses of 1.4 and 8%
4- Determining the severity of symptoms in patients with eczema after consuming peppermint essential oil in doses of 1.4 and 8%
Design
Clinical trial with control group, with parallel groups, three-way blind, randomized, phase 2 on 120 patients. Sealed envelopes were used for randomization.
Settings and conduct
Diagnosis will be made by a specialist. Lavender and peppermint essential oils are prepared in doses of 1.4, 8% and are given to the patient for topical use (twice a day) in the amount of 30 grams with Osrin base. Two weeks later, the reduction in symptoms is checked, and then the observations are recorded on the questionnaire. Patients, physicians, questioners, and data analysts associated with the study outcome are unaware of the codes associated with each formulation. The researcher is not involved in this process. The drugs were placed in envelopes and given to the doctor.
Participants/Inclusion and exclusion criteria
Exclusion criteria: Patients who have had a corticosteroid injection or have taken other oral or topical medications will be excluded.
Intervention groups
The receiving intervention group has developed a drug that includes placebo.
Main outcome variables
Improving the severity of symptoms is assessed in patients.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20100420003760N4
Registration date:2020-07-29, 1399/05/08
Registration timing:registered_while_recruiting
Last update:2020-07-29, 1399/05/08
Update count:0
Registration date
2020-07-29, 1399/05/08
Registrant information
Name
Marzieh Rashidipour
Name of organization / entity
Lorestan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 916 667 4776
Email address
m.rashidipour@lums.ac.ir
Recruitment status
Recruitment complete
Funding source
Lorestan University of Medical Sciences
Expected recruitment start date
2017-01-19, 1395/10/30
Expected recruitment end date
2022-02-20, 1400/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Compare the effectiveness of betamethasone and lavender and peppermint in reducing the severity of symptoms in patients with eczema and psoriasis
Public title
Compare the effectiveness of betamethasone and lavender and peppermint in reducing the severity of symptoms in patients with eczema and psoriasis
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Inclusion criteria: The study population of men and women over the age of 10 with eczema or psoriasis who have been referred to the nomadic hospital since the beginning of the fall of 2016 for one year.
Exclusion criteria:
Patients who have had a corticosteroid injection or have taken other oral or topical medications will be excluded.
Age
From 10 years old to 90 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Patients, physicians, questioners, and data analysts associated with the study outcome are unaware of the codes associated with each formulation. The researcher is not involved in this process. The drugs were placed in envelopes and given to the doctor.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Lorestan University of Medical Sciences Ethics Committee
Street address
Lorestan university medical of sciences
City
Khorramabad
Province
Lorestan
Postal code
6814989468
Approval date
2016-12-26, 1395/10/06
Ethics committee reference number
LUMS.REC.1395.169
Health conditions studied
1
Description of health condition studied
eczema and psoriasis
ICD-10 code
L40.9, L85
ICD-10 code description
Dry skin dermatitis, Psoriasis, unspecified
2
Description of health condition studied
Psoriasis
ICD-10 code
L40.9, L85
ICD-10 code description
Dry skin dermatitis, Psoriasis, unspecified
Primary outcomes
1
Description
scaly
Timepoint
0,7,14
Method of measurement
Questionnaire
2
Description
painful
Timepoint
0,7,14
Method of measurement
Questionnaire
3
Description
Itching
Timepoint
0,7,14
Method of measurement
Questionnaire
4
Description
skin lesions
Timepoint
0,7,14
Method of measurement
Questionnaire
5
Description
swelling
Timepoint
0,7,14
Method of measurement
Questionnaire
6
Description
redness of the skin
Timepoint
0,7,14
Method of measurement
Questionnaire
Secondary outcomes
1
Description
Skin irritation
Timepoint
Days 1,7,14
Method of measurement
Questionnaire
Intervention groups
1
Description
Intervention group: receive the essential oil of Lavendula ooficinalis 3 % b.i.d Up to two weeks
Category
Treatment - Drugs
2
Description
Intervention group: receive the essential oil of Lavendula ooficinalis 5 % b.i.d Up to two weeks
Category
Treatment - Drugs
3
Description
Intervention group: receive the essential oil of Lavendula ooficinalis 7 % b.i.d Up to two weeks
Category
Treatment - Drugs
4
Description
Control group: receive Eucerin b.i.d Up to two weeks
Category
Placebo
5
Description
Control group: receive Betamethasone b.i.d Up to two weeks
Category
Treatment - Drugs
6
Description
Intervention group: receive the essential oil of Menthe piperita 5% b.i.d Up to two weeks
Category
Treatment - Drugs
7
Description
Intervention group: receive the essential oil of Menthe piperita 7 % b.i.d Up to two weeks
Category
Treatment - Drugs
8
Description
Intervention group: receive the essential oil of Menthe piperita 3% b.i.d Up to two weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shohadaye Ashayer Hospital
Full name of responsible person
ِMarzieh Rashidipour
Street address
Lorestan University of Medical Sciences, Anooshirvan Rezaei Square, Khorramabad, Lorestan, Iran.
City
Khorramabad
Province
Lorestan
Postal code
6813833946
Phone
+98 66 3312 0172
Fax
+98 66 3312 0173
Email
m_rashidi80@yahoo.com
Web page address
http://en.lums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Dr.Ebrahim falahi
Street address
Lorestan University of Medical Sciences, Anooshirvan Rezaei Square, Khorramabad,