Pilot clinical trial to evaluate the effectiveness of Herbal Cyclotide complex syrup as a prevention of disease complications in people exposed to COVID-19 virus
Determination of the effectiveness of Cyclotide complex in the prevention of COVID-19 virus after exposure to patients with COVID-19 and comparison with the control group
Design
This clinical trial has a control group, and is performed in parallel, randomized, phase 2 to 3 groups on 60 healthy individuals in exposure to a patient with COVID-19. Randomization will be by block randomization (quadruple random blocks).
Settings and conduct
Participants (individuals in direct contact with patients with COVID-19 (including treatment staff working in isolated areas or housemates with patients with a negative PCR test) in the drug group should drink the syrup for fourteen days and They consume 20 ml every 8 hours. The control group did not receive any medication. The study place is Baqiyatallah Al-Azam Hospital.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1. People over the age of 18 who have had close contact with a person with COVID-19 in the last 4 days and signed an informed consent form (close contact refers to those who live at home with an infected person or, depending on circumstances) Have an occupation less than two meters away from the infected person.) And have no previous or current history of COVID-19.
Exclusion criteria:
1. Current COVID-19 disease, which is confirmed by PCR and clinical signs.
Intervention groups
The intervention groups will be two groups. The participants in the drug group use herbal syrup as a prevention and the control group does not use any specific drug.
Main outcome variables
RT-PCR result
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160131026298N4
Registration date:2020-08-04, 1399/05/14
Registration timing:registered_while_recruiting
Last update:2020-08-04, 1399/05/14
Update count:0
Registration date
2020-08-04, 1399/05/14
Registrant information
Name
Ahmad Reza Sharifi Olounabadi
Name of organization / entity
Baqiatallah University of Medical Science, Department of Traditional Iranian Medicine
Country
Iran (Islamic Republic of)
Phone
+98 21 8804 0060
Email address
a-sharifi@shahed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-20, 1399/02/01
Expected recruitment end date
2020-09-22, 1399/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Pilot clinical trial to evaluate the effectiveness of Herbal Cyclotide complex syrup as a prevention of disease complications in people exposed to COVID-19 virus
Public title
Evaluation of the effectiveness of Cyclotide complex herbal syrup in preventing COVID-19 virus in exposed individuals
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
People over the age of 18 who have had close contact with a person with COVID-19 in the last 4 days and signed an informed consent form (close contact is defined as those who live at home with an infected person or depending on their employment situation in Less than two meters away from the infected person.) And have no previous or current history of COVID-19.
Age between 18 and 70 years
No previous diagnosis of COVID-19 (if possible, test negative for IgG and IgM antibodies.)
Absence of symptoms such as fever, body aches, olfactory and taste disturbances, cough, shortness of breath, diarrhea in the last 1 month
Exclusion criteria:
Current incidence of COVID-19 is confirmed by PCR and clinical signs.
History of autoimmune disease
History of rheumatic disease
Pregnancy and lactation
Age under 18 years
People sensitive to any component of the product
People who can not follow up.
Any clinical reason that may prevent you from entering the study.
Do not take two doses of the drug
Age
From 18 years old to 70 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
Randomization will be by block randomization (quadruple random blocks). Randomization units are individuals. 60 outpatients referred to the hospital emergency department are allocated in one of the two intervention and control groupsaccording to form of random string produced by online random allocation . This study is a non-concealed method and people in the intervention group will receive the intervention drug to prevent COVID-19 complications, but in the control group the drug is not used.
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 Baqiyatallah University of Medical Sciences
Street address
Baqiyatallah University of Medical Sciences, Shahid Nosrati Alley, Shaikh Bahai St., Vanak Square, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1435916471
Approval date
2020-06-21, 1399/04/01
Ethics committee reference number
IR.BMSU.REC.1399.250
Health conditions studied
1
Description of health condition studied
COVID-19 viral disease
ICD-10 code
B34.2
ICD-10 code description
Coronavirus infection, unspecified
Primary outcomes
1
Description
Polymerase chain reaction (PCR) analysis result
Timepoint
At the beginning of the intervention and the day 14
Method of measurement
Polymerase chain reaction (PCR) analysis
2
Description
Liver function test result
Timepoint
At the beginning of the intervention and the day 14
Method of measurement
Measurement of aspartate aminotransferase (AST) and Alanine transaminase (ALT) factors
3
Description
Fragment D-dimer test result
Timepoint
At the beginning of the intervention and the day 14
Method of measurement
Blood test - Fragment D-dimer measurement
4
Description
Measurement of serum iron
Timepoint
At the beginning of the intervention and the day 14
Method of measurement
Blood test - Total iron binding capacity factor (TIBC) measurement
5
Description
COVID-19 Antibodies
Timepoint
At the beginning of the intervention and the day 14
Method of measurement
Measurement of IgG COVID-19 and IgM COVID-19 factors
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Consumable product includes herbal syrup composed of cyclopeptide fraction with Ziziphus spina-cristi and Pimpinela anisum hydroalcoholic extract and orange peel. The dose of the product is 20 ml every 8 hours after eating, which is prepared by Herbi Pharmed Pharmaceutical Company.
Category
Prevention
2
Description
Control group: do not use any drugs for prevention and only follow health protocols to prevent infection.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Baqiyatallah Hospital
Full name of responsible person
AHMAD REZA SHARIFI OLOUNABADI
Street address
Mulla Sadra Street, Vanak Square, After Sheikh Baha'i, Baqiyatallah Hospital
City
Tehran
Province
Tehran
Postal code
1435915371
Phone
+98 21 8805 0436
Email
a-sharifi@shahed.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Gholamhosein Alishiri
Street address
Baqiyatallah University, Third Floor, Vice-Chancellor for Research and Technology, Sheikh Bahai St, Mulla Sadra St,Vanak Square
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8755 5250
Email
a-sharifi@shahed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Herbi Pharmed pharmaceutical company
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Other
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Shiva Shamshiri
Position
PhD Candidate
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
No.4, Gholhak Ave, Shari'ati Blvd
City
Tehran
Province
Tehran
Postal code
1913844819
Phone
+98 21 2642 1927
Email
shiva.shamshiri90@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
shiva shamshiri
Position
PhD candidate
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
No.4, Gholhak Ave, Shari'ati Blvd
City
Tehran
Province
Tehran
Postal code
1913844819
Phone
+98 21 2642 1927
Email
shiva.shamshiri90@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
shiva shamshiri
Position
PhD candidate
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
No. 4, Gholhak Ave, Shari'ati Blvd
City
Tehran
Province
Tehran
Postal code
1913845213
Phone
+98 21 2642 1927
Email
shiva.shamshiri90@yahoo.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
Pay attention to organizational rules
Study Protocol
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be 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