Protocol summary

Summary
The aim of this double blind, randomized clinical trail is to evaluate the therapeutic effect of honey, olive oil and citrus lemon juice combination (ratio1,1,0.5) vs. Eucerin on cracked foot. Boxes of creams are similar. Personnel and patients are unaware of the contents of the boxes. Inclusion criteria are:1-Consent for the participation in the study, 2-Ability to read and write, 3- Age ranging 15-55 years, 4-Both feet have similar cracks. Exclusion criteria are: 1- Determent of the continuation of the study, 2- Suffering from other skin disease. Thirty patients enter the study and each of their feet enter in one group. One group receive combination cream and another group receive Eucerin daily for 1 month. Cracks are assessed at the beginning and two weeks and one month later.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT138806162428N1
Registration date: 2009-09-23, 1388/07/01
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2009-09-23, 1388/07/01
Registrant information
Name
Maryam Rasty
Name of organization / entity
Shahrekord Univercity of Medicsal Sciences
Country
Iran (Islamic Republic of)
Phone
+98 38 1334 9509
Email address
rasti@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Institute of Islamic medicine and complementary medical history of Iran University of Medical Sciences
Expected recruitment start date
2009-09-23, 1388/07/01
Expected recruitment end date
2010-08-21, 1389/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of combination of Honey, Olive oil and Citrus Limon juice on cracked heel
Public title
Treatment of cracked heel with herbal Cream
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria are: 1-Consent for the participation in the study; 2-Ability to read and write; 3- Age range 15-55 years; 4-Both feet have similar cracks. Exclusion criteria are: 1- Determent of the continuation of the study; 2- Suffering from other skin disease.
Age
From 15 years old to 55 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Institute of Islamic medicine and complementary medical history, Iran University of Medical Sciences
Street address
No. 423 / 1, North lalezar, Lalhzar Alley
City
Tehran
Postal code
88155-137
Approval date
2009-08-15, 1388/05/24
Ethics committee reference number
107 Code .Letter No. 520/ط/م/26پ

Health conditions studied

1

Description of health condition studied
feet cracked
ICD-10 code
L98
ICD-10 code description
Other disorders of skin and subcutaneous tissue, not elsewhere classified

Primary outcomes

1

Description
No. of cracks
Timepoint
Beginning of the study, two weeks and one month after the study
Method of measurement
observation and Questionnaire of GRADING SCALE DESCRIPTIONS

Secondary outcomes

1

Description
Satisfaction of patients
Timepoint
end of 4th week
Method of measurement
questionnaire

2

Description
Side effects including redness, dryness, bleeding, itching , ...
Timepoint
throughout the study
Method of measurement
questionnaire

Intervention groups

1

Description
combination of Honey, Olive oil and Citrus Limon juice on cracked heel
Category
Treatment - Drugs

2

Description
Euserin on cracked heel
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Skin Clinic
Full name of responsible person
Dr Hossein Shabanzadeh
Street address
Fasihi crossroad
City
Shahrekord

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Institute of Islamic medicine and complementary medical history, Iran University of Medical Sciences
Full name of responsible person
Dr Dabaghiyan
Street address
Lalehzar Street, Jomhoorei Islamei street
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Institute of Islamic medicine and complementary medical history, Iran University of Medical Sciences
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
Name of organization / entity
Shahrekord University Of Medical Sciences
Full name of responsible person
Maryam Rasty
Position
Nurse
Other areas of specialty/work
Street address
Shahrekord University Of Medical Sciences
City
Shahrekord
Postal code
88155-137
Phone
+98 38 1334 9509
Fax
Email
rasty-44@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahrekord University Of Medical Sciences
Full name of responsible person
Dr Hosain Shabanzadeh
Position
PhD
Other areas of specialty/work
Street address
Shahrekord University Of Medical Sciences
City
Shahrekord
Postal code
88155-137
Phone
+98 38 1334 9509
Fax
+98 38 1334 9509
Email
dehkordi766@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shahrekord university of medical sciences
Full name of responsible person
Maryam Rasti
Position
Nurse
Other areas of specialty/work
Street address
Shahrekord university of medical sciences, Vice chancellery for Research, Kashani St.
City
Shahrekord
Postal code
0381-3349509
Phone
+98 913 380 2527
Fax
Email
rasty_44@yahoo.comrasti@skums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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