Protocol summary

Study aim
Determining the comparative effect of zinc supplementation along with finasteride and zinc supplementation alone on the treatment of patients suffering from hair loss after contracting covid-19 who referred to Booali Hospital in Tehran in 2023
Design
The clinical trial, with parallel groups, double-blind, simple randomized, phase 4, is conducted on 64 patients referred to the skin clinics of the Islamic Azad University Hospitals from June to August of 2023.
Settings and conduct
The study subjects will be selected from among the patients with noticeable hair loss and a history of covid-19 infection for at least the last six months who referred to the skin clinics of Booali Hospital in Tehran in 2023, who meet the inclusion criteria, so that the sample size is equal to the number of cases. comment Then the patients are divided into two simple random double-blind groups that are matched with each other in terms of age, gender and underlying disease.
Participants/Inclusion and exclusion criteria
All those who have been infected with Covid-19 for more than 6 months Noticeable hair loss Age 20 to 55 years Consent of the person to participate in the study Patients treated with other drugs to control hair loss Suffering from mental disorders such as anxiety and depression
Intervention groups
Intervention group 1: For three months, they take one finasteride tablet of 5 mg after breakfast and one zinc sulfate tablet containing 10 mg of zinc elemental after lunch. Intervention group two: During the same period of time, they take one zinc sulfate tablet containing 10 mg of zinc elemental after lunch. All patients are evaluated for the amount of hair loss after three months of intervention.
Main outcome variables
The effect of zinc supplementation along with finasteride and zinc supplementation alone on the treatment of hair loss patients with a history of covid-19

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230531058350N1
Registration date: 2023-06-13, 1402/03/23
Registration timing: registered_while_recruiting

Last update: 2023-06-13, 1402/03/23
Update count: 0
Registration date
2023-06-13, 1402/03/23
Registrant information
Name
Pegah Raeisi Fard
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2200 6660
Email address
pegah.raeisifard@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-06-10, 1402/03/20
Expected recruitment end date
2023-07-11, 1402/04/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of zinc supplement along with finasteride and zinc supplement alone in the treatment of patients with hair loss and a history of covid-19 infection
Public title
Investigating the effect of finasteride and zinc supplement on hair loss after covid-19 infection
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All those who have been infected with Covid-19 for more than 6 months Noticeable hair loss
Exclusion criteria:
Age
From 20 years old to 55 years old
Gender
Both
Phase
4
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 64
Randomization (investigator's opinion)
Randomized
Randomization description
The table of random numbers is prepared and by placing a hand on a number randomly and moving the hand in one of the predetermined directions, each person is given a number. People who have even numbers in will be in intervention group A and individual numbers will be in the group Intervention B.
Blinding (investigator's opinion)
Double blinded
Blinding description
The participants in both groups and the researcher remain unaware of how the type of drug is allocated during the study. The patient is informed that there are two types of drug packages in a study and they will receive one of them randomly. Both are similar in packaging and have no difference.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committees of Tehran Islamic Azad University Of Medical Sciences
Street address
Tehran Islamic Azad University of Medical Sciences, Khaghani St, Shariati Ave
City
TEHRAN
Province
Tehran
Postal code
19499160112
Approval date
2022-10-01, 1401/07/09
Ethics committee reference number
IR.IAU.TMU.REC.1401.252

Health conditions studied

1

Description of health condition studied
hair loss
ICD-10 code
L65.9
ICD-10 code description
Nonscarring hair loss, unspecified

Primary outcomes

1

Description
Determining the comparative effect of zinc supplementation along with finasteride and zinc supplementation alone on the treatment of patients with hair loss after contracting the covid-19 disease
Timepoint
Three months after the intervention
Method of measurement
The opinion of two dermatologist separately

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: For three months, receiving one finasteride 5 mg tablet after breakfast and one zinc sulfate tablet containing 10 mg zinc elemental after lunch.
Category
Treatment - Drugs

2

Description
Intervention group: For three months, take one tablet of zinc sulfate containing 10 mg of elemental zinc after lunch
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Booali hospital
Full name of responsible person
Hoda Ghoreshi Rad
Street address
Booali Hospital, Damavand St., Imam Hossein Square
City
Tehran
Province
Tehran
Postal code
1711734365
Phone
+98 21 3334 8036
Fax
+98 21 3378 6182
Email
booali.hospital96@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
ّFarshad Hashemian
Street address
Tehran Islamic Azad University of Medical Sciences , Khaghani St, Shariati Ave
City
Tehran
Province
Tehran
Postal code
1916893813
Phone
+98 21 2200 6660
Email
chancellor@iautmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
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
Islamic Azad University
Full name of responsible person
Hoda Ghoreshi Rad
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Booali Hospital, Damavand St., Imam Hossein Square
City
Tehran
Province
Tehran
Postal code
1711734365
Phone
+98 21 3334 8036
Email
drghoreishirad@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Hoda Ghoreshi Rad
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Booali Hospital, Damavand St., Imam Hossein Square
City
Tehran
Province
Tehran
Postal code
1711734365
Phone
+98 21 3334 8036
Email
drghoreishirad@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Hoda Ghoreshi Rad
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Booali Hospital, Damavand St., Imam Hossein Square
City
Tehran
Province
Tehran
Postal code
1711734365
Phone
+98 21 3334 8036
Email
drghoreishirad@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There are currently no plans to publish.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not 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
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