The evaluation of efficacy of topical formulation of Henna (Lawsonia inermis) in prevention of contact dermatitis in patients using prosthesis
Design
In this study, 72 patients with lower limbs amputation who prosthesis are prescribed for them and are eligible for entering the project, and are referred to the Shiraz Red Crescent Center for Comprehensive Rehabilitation are included in the study. The patients will randomly assigned to two parallel intervention and control groups and one code is allocated to hide the group of each participant.
Settings and conduct
In this study, patients ،researcher and statistic analyzer will be blinded .
Participants/Inclusion and exclusion criteria
Inclusion criteria: lower limb amputees; prosthesis; no systemic diseases; no skin disorders. Exclusion criteria: sensitivity and allergy to henna or hair dye.
Intervention groups
Intervention group: Henna extract cream 1%, 3 times/day for 3 months
Control group: placebo cream , 3 times/day for 3 months
Main outcome variables
Moisture, erythema, elasticity, itching and pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171229038126N1
Registration date:2018-04-29, 1397/02/09
Registration timing:prospective
Last update:2018-04-29, 1397/02/09
Update count:0
Registration date
2018-04-29, 1397/02/09
Registrant information
Name
Mehdi Niazi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3228 6057
Email address
m.niazi@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-05-20, 1397/02/30
Expected recruitment end date
2019-01-20, 1397/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The evaluation of efficacy of topical formulation of Henna (Lawsonia inermis) in prevention of contact dermatitis in patients using prosthesis
Public title
The evaluation of efficacy of topical formulation of Henna (Lawsonia inermis) in prevention of contact dermatitis in patients using prosthesis
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Lower extremity amputation
Lower extremity prothesis
Age of 12-70 years old
Exclusion criteria:
Any diagnosed dermatological disorder
Any diagnosed systemic disorder (i.e Diabetes)
Pregnancy or lactation
Allergy to Henna or hair coloring agents
Age
From 12 years old to 70 years old
Gender
Both
Phase
1-2
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
72
Randomization (investigator's opinion)
Randomized
Randomization description
The patients will be divided in two equal parallel groups with block randomization method
Blinding (investigator's opinion)
Triple blinded
Blinding description
The patients will be blinded by using similar drug tubes
The clinical investigator will not deliver the drugs
The statistician will receive the data in two groups labeled as A and B without identification
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
The road of Haft Bagh Kerman University of Medical Sciences Kerman
City
Kerman
Province
Kerman
Postal code
76169-13555
Approval date
2018-04-16, 1397/01/27
Ethics committee reference number
IR.KMU.REC.1397.021
Health conditions studied
1
Description of health condition studied
Contact Dermatitis
ICD-10 code
L24
ICD-10 code description
Irritant contact dermatitis
Primary outcomes
1
Description
Pruritus
Timepoint
0, 1, 2, 3 months
Method of measurement
VAS (Visual Analogue Scale)
Secondary outcomes
1
Description
Skin Moisture
Timepoint
Month :0-1-2-3
Method of measurement
KC Technology
2
Description
Skin erythema
Timepoint
Month:0-1-2-3
Method of measurement
KC Technology instrument
3
Description
Skin elasticity
Timepoint
Month:0-1-2-3
Method of measurement
KC Technology instrument
4
Description
Pain
Timepoint
Month;0-1-2-3
Method of measurement
visual Analogue Scale (VAS)
5
Description
Quality of life
Timepoint
Month:0-1-2-3
Method of measurement
questionnaire
Intervention groups
1
Description
Henna extract cream 1%, 3 times/day for 3 months
Category
Prevention
2
Description
Control group: placebo cream , 3 times/day for 3 months
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Red Crescent ,Rehabilitation Center Shiraz
Full name of responsible person
Mehdi Niazi
Street address
Sibouyeh Boulevard, Red Crescent Rehabilitation Center Shiraz
City
Shiraz
Province
Fars
Postal code
87548-25897
Phone
+98 71 3233 4444
Email
mehdineazi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Dr. Mehrzad Mehrabani
Street address
Road of Haft Bagh Kerman University of Medical Sciences
City
Kerman
Province
Kerman
Postal code
76169-13555
Phone
+98 34 3312 2023
Fax
Email
mzmehrabani@yahoo.com
Web page address
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
Dr.Mehrzad Mehrabani
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
The road of Haft Bagh Kerman University of Medical Sciences