Evaluation of effect of Wharton's umbilical cord jelly on mother‘s melasma
Design
In this research, 50 mothers with melasma referring to Anadan and Khoramshahr hospital were chosen purposefully and were randomly divided into two groups of control and intervention.Group allocation was concealed by assigning a unique code to each participants.
Settings and conduct
Mothers with melasma referring to Abadan and Khoramshahr hospitals will be registered for this study. Patient and investigators evaluating melasma will be blinded to the type of therapy
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Mothers with melasma
Exclusion Criteria: Exposure to the direct sun light, Systemic steroid therapy, Suffering from another skin disease such as rash and acne, Suffering from systemic disease with dermatological signs such as Hepatitis C and Lupus Erythematosus
Intervention groups
Treatment group: Mother with melasma treated with Wharton's Jelly
Control group: Mother with melasma treated with the base of cream
Main outcome variables
Melasma
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180116038386N1
Registration date:2018-04-21, 1397/02/01
Registration timing:retrospective
Last update:2018-04-21, 1397/02/01
Update count:0
Registration date
2018-04-21, 1397/02/01
Registrant information
Name
Maryam Adelipour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 5326 7800
Email address
m.adelipour@abadanums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-02-20, 1396/12/01
Expected recruitment end date
2018-03-21, 1397/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of umbilical cord Wharton's jelly on mother‘s melasma
Public title
Effect of umbilical cord Wharton's jelly in treatment of melasma
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Pregnant mother with melasma
Exclusion criteria:
Another skin disease such as rash, acne, .....
Systemic disease with dermatological signs such as Hepatitis C Virus , Lupus Erythematosus, ....
Systemic steroid therapy
Exposure to direct sunlight
Age
From 18 years old to 40 years old
Gender
Female
Phase
0
Groups that have been masked
No information
Sample size
Target sample size:
25
Randomization (investigator's opinion)
Randomized
Randomization description
Method of randomization will be simple. Unit of randomization will be individual. Tools of randomization will be random number table. Person randomising the patient does not know what the next treatment allocation will be.
Blinding (investigator's opinion)
Double blinded
Blinding description
For elimination of the possibility of any probable bias due to the knowledge of patients and investigators about the type of treatment we will perform a double blind study. The patients and investigators were blinded to treatment type (Wharton's Jelly or base of cream). placebo (base of cream) will be similar to Wharton jelly in figure, color and volume. Wharton's Jelly or base of cream is used on face of patients topically by a educated person.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committees of Abadan University of Medical Science
Street address
Airport Blvd
City
Abadan
Province
Khouzestan
Postal code
6313833177
Approval date
2017-10-09, 1396/07/17
Ethics committee reference number
IR.ABADANUMS.REC.1396.245
Health conditions studied
1
Description of health condition studied
Melasma
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Melasma
Timepoint
Before intervention and 6 weeks after intervention
Method of measurement
Melasma area severity index (MASI)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: A part of umbilical cord (10 cm) will be cut immediately after parturition and will be washed in sterile plate using sterile normal saline. Warthon Jelly will be extracted using a razor blade. Extracted warthon jelly will be used on hyperpigmentation area of mothers face topically. This intervention will be single dose.
Category
Treatment - Other
2
Description
Control group: Base of cream. single dose
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti Hospital
Full name of responsible person
Hanan Sorkheh
Street address
Ahmad Abad
City
Abadan
Province
Khouzestan
Postal code
6316648371
Phone
+98 61 5332 9400
Email
M.Adelipour@Abadanums.ac.ir
2
Recruitment center
Name of recruitment center
Valiasr Hospital
Full name of responsible person
Horia Bahrami
Street address
Shohadaye Sazeman Ab Boulevard
City
Khoramshahr
Province
Khouzestan
Postal code
6418733891
Phone
+98 61 5354 4800
Email
M.Adelipour@Abadanums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Abadan University of Medical Sciences
Full name of responsible person
Dr. Nouri
Street address
Abadan Faculty of Medical Science, Ayatollah Jami Ariport, Airport sq, Abadan, Iran
City
Abadan
Province
Khouzestan
Postal code
6313833177
Phone
+98 61 5326 7800
Email
m.adelipour@abadanums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Abadan 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
Abadan University of Medical Sciences
Full name of responsible person
Maryam Adelipour
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Biochemistry
Street address
Abadan Faculty of Medical Science, Ayatollah Jami Ariport, Airport sq, Abadan, Iran
City
Abadan
Province
Khouzestan
Postal code
6313833177
Phone
+98 61 5326 7800
Fax
Email
M.Adelipour@Abadanums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Abadan University of Medical Sciences
Full name of responsible person
Maryam Adelipour
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Biochemistry
Street address
Abadan Faculty of Medical Science, Ayatollah Jami Ariport, Airport sq, Abadan, Iran
City
Abadan
Province
Khouzestan
Postal code
6313833177
Phone
+98 61 5326 7800
Fax
Email
M.Adelipour@Abadanums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Abadan University of Medical Sciences
Full name of responsible person
Maryam Adelipour
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Biochemistry
Street address
Abadan Faculty of Medical Science, Ayatollah Jami Ariport, Airport sq, Abadan, Iran
City
Abadan
Province
Khouzestan
Postal code
6313833177
Phone
+98 61 5326 7800
Fax
Email
M.Adelipour@Abadanums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All of data will be shared.
When the data will become available and for how long
One month after publishing data
To whom data/document is available
Researcher in each field
Under which criteria data/document could be used
Use in therapy
From where data/document is obtainable
Authors of article
What processes are involved for a request to access data/document