Protocol summary

Study aim
Investigating the effect of vitamin B1 on the symptoms of post covid-19 syndrome
Design
A clinical trial with a control group, with a parallel group, randomized on 60 patients, rand function of Excel software was used for randomization.
Settings and conduct
60 patients of Labafinejad Hospital who are eligible entered the study and were divided into two groups of 30 people, the treatment group and the control group.
Participants/Inclusion and exclusion criteria
A patient who is eligible to enter the study (patients who have recovered from the disease of Covid-19, but their symptoms still persist more than usual, after three weeks of the onset of the symptoms of Covid-19, they also have symptoms such as fatigue, sleep disorders, decreased sense of taste and smell , etc.) Criteria for not entering the study: pregnant women, patients who use antipsychotic drugs, and patients with immundefitiency
Intervention groups
Control group receives only supportive therapy (vitamin C, Famotidine, and Zinc) daily for 8 weeks. Intervention group receives vitamin B1 tablet (600 mg) daily for 8 weeks, in addition to the supportive therapy.
Main outcome variables
Sleep quality, Hair loss, Skin rashes, Dyspnea

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20221229056979N1
Registration date: 2023-05-31, 1402/03/10
Registration timing: retrospective

Last update: 2023-05-31, 1402/03/10
Update count: 0
Registration date
2023-05-31, 1402/03/10
Registrant information
Name
Elmira Mahmoudi Chalmiani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 4203 0898
Email address
dr.elmira_1991@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-03-21, 1401/01/01
Expected recruitment end date
2023-03-21, 1402/01/01
Actual recruitment start date
2022-03-21, 1401/01/01
Actual recruitment end date
2023-03-21, 1402/01/01
Trial completion date
2023-06-21, 1402/03/31
Scientific title
Investigating the effect of vitamin B1 oral tablets on the post covid-19 syndrome in comparison with the control group
Public title
Investigating the effect of vitamin B1 oral tablets on the post covid-19 syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All Patients who have recovered from covid 19 but after three weeks the symptoms of post covid 19 syndrome remain
Exclusion criteria:
Pregnancy Immune deficiency patients Patients who use antipsychotic drugs
Age
From 15 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Actual sample size reached: 60
Randomization (investigator's opinion)
Randomized
Randomization description
First, 60 patients who are eligible to enter the study (patients who have recovered from the disease of covid-19, but their symptoms are still more than usual, after three weeks of the onset of symptoms of covid-19, have symptoms such as fatigue, sleep disorders, loss of sense of taste and smell, chest pain, cough, joint pain, hair loss, skin rashes, etc.) are at the time of admission background information including sex, age, clinical and drug records, disease manifestations and laboratory findings as well as symptoms Vitality and severity of the disease, history of hospitalization and receiving corticosteroids will be collected from the patients and recorded in the study checklist. Then for the patients of the treatment group (30 people) who will be randomly selected.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Shahid Beheshti University of Medical Sciences
Street address
School of medicine of Shahid Beheshti University of medical sciences, Koodakyar Ave., Daneshjoo Blvd,. Yaman St,. Chamran highway.
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2021-08-10, 1400/05/19
Ethics committee reference number
IR.SBMU.MSP.REC.1400.286

Health conditions studied

1

Description of health condition studied
Post covid-19 syndrome
ICD-10 code
U07.1
ICD-10 code description
COVID-19, virus identified

Primary outcomes

1

Description
Sleep quality
Timepoint
Patients will be examined weekly during 9 weeks and the checklist will be completed for them.
Method of measurement
Questionnaire

2

Description
Hair loss
Timepoint
Patients will be examined weekly during 9 weeks and the checklist will be completed for them.
Method of measurement
Questionnaire

3

Description
Skin rashes
Timepoint
Patients will be examined weekly during 9 weeks and the checklist will be completed for them
Method of measurement
Questionnaire

4

Description
Dyspnea
Timepoint
Patients will be examined weekly during 9 weeks and the checklist will be completed for them
Method of measurement
Questionnaire

Secondary outcomes

1

Description
Quality of life score
Timepoint
Patients will be examined weekly during 9 weeks and the checklist will be completed for them.
Method of measurement
Questionnaire

Intervention groups

1

Description
Control group: Control group receives only supportive therapy including vitamin C, Famotidine, and Zinc (one tablet for each supplement) orally for 8 weeks.
Category
Treatment - Drugs

2

Description
Intervention group: Intervention group receives vitamin B1 (600 mg daily for 8 weeks) in addition to supportive therapy (same as control group).
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Labafinezhad hospital
Full name of responsible person
Shabnam Tehrani
Street address
9th Boostan St., Pasdaran, Tehran
City
Tehran
Province
Tehran
Postal code
1666663111
Phone
+98 21 2360 2085
Email
dr.elmira_1991@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Afshin Zarghi
Street address
Shahid Beheshti University of Medical Sciences, No. 2, Arabi St., Yemen St., Chamran Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 2243 9780
Email
Mpajouhesh@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Shabnam tehrani
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
Zafar
City
Tehran
Province
Tehran
Postal code
1919753973
Phone
+98 21 2360 2084
Email
dr.elmira_1991@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Shabnam tehrani
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
Zafer
City
Tehran
Province
Tehran
Postal code
1919753973
Phone
+98 21 2360 2084
Email
dr.elmira_1991@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Shabnam tehrani
Position
Associate professor
Latest degree
Medical doctor
Other areas of specialty/work
Infectious diseases
Street address
Zafar
City
Tehran
Province
Tehran
Postal code
1919753973
Phone
+98 21 2360 2084
Email
dr.elmira_1991@yahoo.com

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
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Part of the data, such as information related to the main outcome or similar, can be shared
When the data will become available and for how long
The beginning of the access period from 1402
To whom data/document is available
The data will be available only to researchers working in academic and scientific institutions
Under which criteria data/document could be used
Data for clinical use will be available
From where data/document is obtainable
dr.elmira_1991@yahoo.com
What processes are involved for a request to access data/document
After the request, the data will reach the requester within a week.
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