Comparative evaluation of PRP (Platelet-Rich Plasma) with nutritional supplements in improvement of hair loss (telogen effluvium) in patients recovered from COVID-19 in Bam Pasteur hospital in 2022
Comparative evaluation of PRP (Platelet-Rich Plasma) with nutritional supplements in improvement of hair loss (telogen effluvium) in patients recovered from COVID-19 in Bam Pasteur hospital in 2022
Design
The clinical trial consists of two groups without blinding, in which individuals are randomly divided into two groups of 30 people.
Settings and conduct
Patients are treated with PRP at the Pasteur Hospital Dermatology Clinic.
Participants/Inclusion and exclusion criteria
Age 20 to 50 years
Covid 19 disease (positive by PCR test) 2 to 4 months before enrollment
Occurrence of persistent and significant hair loss after Covid 19 disease, which according to the diagnosis of a dermatologist has a pattern similar to telogen effluvium
Intervention groups
Therapeutic intervention in the first group includes nutritional supplements (folic acid, vitamin D, zinc plus and capsule hair vit) which are prescribed to the person daily for three months based on daily needs and BMI.
Therapeutic intervention in the second group includes PRP injection once every three weeks for four sessions.
At the end of three months, the patients will be visited again by a primary dermatologist.
Main outcome variables
Considering the effects of PRP on hair loss in other studies and since so far there are very limited studies on the effect of using PRP on hair loss in patients who have recovered from Covid-19 and comparing it with nutritional supplements.The present study was conducted with the aim of investigating the effect of PRP and nutritional supplements on post-Covid hair loss.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220603055066N1
Registration date:2022-09-28, 1401/07/06
Registration timing:prospective
Last update:2022-09-28, 1401/07/06
Update count:0
Registration date
2022-09-28, 1401/07/06
Registrant information
Name
faeze bahadornia
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 4431 1925
Email address
faezebahadornia@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-10-02, 1401/07/10
Expected recruitment end date
2022-12-31, 1401/10/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative evaluation of PRP (Platelet-Rich Plasma) with nutritional supplements in improvement of hair loss (telogen effluvium) in patients recovered from COVID-19 in Bam Pasteur hospital in 2022
Public title
Comparative evaluation of PRP with nutritional supplements in improvement of hair loss in patients recovered from COVID-19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 20 to 50 years
Covid 19 disease (positive by PCR test) 2 to 4 months before enrollment
Occurrence of persistent and significant hair loss after Covid 19 disease, which according to the diagnosis of a dermatologist has a pattern similar to telogen effluvium
Exclusion criteria:
People who are diagnosed as the other types of alopecia (except telogen effluvium)
Pregnant or lactating women
Patients who are being treated with drugs such as finasteride, spironolactone, minoxidil or OCP or who have recently stopped taking these drugs
Patients who have an underlying disease affecting hair loss
Lack of informed consent to enter the study
Age
From 20 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
ethics committee of Bam university of medical sciences
Street address
No.27, Alley 3, Saiyid ush shohada Blvd
City
Bam
Province
Kerman
Postal code
7661777997
Approval date
2022-05-20, 1401/02/30
Ethics committee reference number
IR.MUBAM.REC.1401.023
Health conditions studied
1
Description of health condition studied
telogen effluvium
ICD-10 code
L65.0
ICD-10 code description
Telogen effluvium
Primary outcomes
1
Description
The amount of hair loss
Timepoint
The beginning of the study , 21 , 42 , 63
Method of measurement
Hair pull test
2
Description
The level of satisfaction of the state of hair loss, increased hair growth and hair quality
Timepoint
The beginning of the study , 21 , 42 , 63
Method of measurement
The satisfaction questionnaire is based on the examination of hair loss before and after the intervention, as well as the satisfaction level regarding the state of hair loss, increased hair growth and hair quality based on a five-point scale from very dissatisfied, which means a score of 0, to very satisfied, which means a score of 5. .
Secondary outcomes
empty
Intervention groups
1
Description
Therapeutic intervention in the first group includes nutritional supplements (folic acid, vitamin D, zincplus and hair vit.) which are prescribed to the person daily for three months based on daily needs and BMI.
Category
Treatment - Drugs
2
Description
The therapeutic intervention in the second group includes PRP injection once every three weeks and for four sessions. It should be noted that PRP is used autologously and from the patient's own blood product, and the obtained PRP is used only for the patient himself. In this way, 20 ml of the person's venous blood is introduced by a trained nurse in a tube containing sodium citrate and centrifuged for five minutes at a speed of 1500 rpm. Using a sterile syringe, the plasma is transferred to a tube without anticoagulants by a trained nurse and placed in a second centrifuge at 2500 rpm for 20 minutes.The resulting PRP is then collected. Each time PRP is injected intradermally at a dose of 0.1-0.2 ml per injection at a distance of about one centimeter in the interfollicular areas of the frontal and vertebral region by a dermatologist.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Pasteur hospital of Bam
Full name of responsible person
faeze bahadornia
Street address
5 km of Bam-Barvat road
City
Bam
Province
Kerman
Postal code
7661961676
Phone
+98 34 4431 9405
Email
faezebahadornia@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Bam University of Medical Sciences
Full name of responsible person
Sahar ebrahimi
Street address
5 km of Bam-Barvat road
City
Bam
Province
Kerman
Postal code
7661961676
Phone
+98 34 4431 9405
Email
faezebahadornia@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Bam 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
Bam University of Medical Sciences
Full name of responsible person
Sahar ebrahimi
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Medical Education
Street address
No. 27, Alley 3, Seyed Al-Shohada Boulevard
City
Bam
Province
Kerman
Postal code
7661777997
Phone
+98 34 4431 1921
Email
faezebahadornia@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bam University of Medical Sciences
Full name of responsible person
Sahar ebrahimi
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Medical Education
Street address
No. 27, Alley 3, Seyed Al-Shohada Boulevard
City
Bam
Province
Kerman
Postal code
7661777997
Phone
+98 34 4431 1921
Email
faezabahadornia@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Bam University of Medical Sciences
Full name of responsible person
Faeze Bahadornia
Position
Medical student
Latest degree
A Level or less
Other areas of specialty/work
Medical Education
Street address
No 27, Alley 3 , Saiyid ush shohada Blvd
City
Bam
Province
Kerman
Postal code
76661777997
Phone
+98 34 4431 1925
Fax
Email
faezebahadornia@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Only part of the information related to the examination of the main outcome is shared.
When the data will become available and for how long
Access starts one month after the results are published
To whom data/document is available
Researchers working in academic and scientific institutions and people working in industry.
Under which criteria data/document could be used
They are allowed to perform statistical analysis
From where data/document is obtainable
Pasteur Hospital of Bam
What processes are involved for a request to access data/document