Protocol summary

Study aim
Evaluation of the effectiveness of oral syrup and nasal spray of Ghaziani plant on the symptoms of patients with COVID-19
Design
This phase 3 clinical trial is performed in a double-blind method on 100 patients with Covid 19 virus. 100 patients are randomly assigned to 50 blocks including 2 patients. Then each of the 2 patients in the block of herbal medicine or placebo with code A or B receives, so that 50 people are assigned herbal medicine and 50 people are placebo. The duration of treatment is one week.
Settings and conduct
100 patients with Covid virus 19 referred to Farabi and Golestan hospitals in Kermanshah has entry conditions, selected and randomly divided into two groups. These patients are cared by a trained nurse and the amount of spo2 and the progress of patients in both groups is recorded daily for a week. The identification code is recorded .The physician, nurse, patient, data collector, and person evaluating the outcome are unaware of the medication and placebo group. Only the project manager know the type of groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with Covid virus 19 aged 20 to 70 years. Exclusion criteria: 1- Pregnant women 2- Children 3- Elderly (people over 70 years old) 4- People who use mechanical ventilation 5- People who are undergoing chemotherapy 6- People who receive corticosteroid pulse
Intervention groups
Intervention group: Patients in this group use syrup and nasal spray prepared from mountain ghaziani plant, which is dried under normal conditions and prepared as a syrup or nasal spray, three times a day for a week. control treatment: Routine treatment according to the latest update of the new national coronavirus treatment guidelines
Main outcome variables
blood oxygen saturation; temperature; Number of breaths;dyspnea ; Cough; Rate of lung involvement

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20130722014106N9
Registration date: 2021-11-30, 1400/09/09
Registration timing: registered_while_recruiting

Last update: 2021-11-30, 1400/09/09
Update count: 0
Registration date
2021-11-30, 1400/09/09
Registrant information
Name
Reza Tahvilian
Name of organization / entity
Kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1427 6482
Email address
rtahvilian@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-11-22, 1400/09/01
Expected recruitment end date
2021-12-21, 1400/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of oral syrup and intranasal spray of Falcaria Vulgaris plant on patients with Covid-19
Public title
Effect of oral syrup and intranasal spray of Falcaria Vulgaris plant in patients with Covid-19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Confirmation of coronavirus infection by CT scan of the chest and PCR test Age 20 to 70 years Willingness to cooperate in the study and completion of informed written consent
Exclusion criteria:
pregnant women children Elderly (people over 70) People who use mechanical ventilation People undergoing chemotherapy People who receive corticosteroids are excluded from the study
Age
From 20 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Outcome assessor
  • Data and Safety Monitoring Board
Sample size
Target sample size: 100
Randomization (investigator's opinion)
Randomized
Randomization description
Using random blocking method (Block Randomization ) with 4 blocks and a ratio of 1: 1 are allocated to the treatment and control groups. (For 4 blocks there will be six different modes: 1.TTCC 2.TCTC 3.TCCT 4.CCTT 5.CTTC 6.CTCT). Random numbers will be created with the help of a computer and a statistics consultant. For numbers between 0 and 1.6, combination 1 (TTCC), numbers between 1.6 and 2.6, combination 2 (TCTC), etc. are divided into two groups of 50 people. Patients based on randomized block allocation method classified according to age range (20 years and later) and gender (male, female) in two groups with 50 people (25 males and 25 females) with Herbal medicine treatment (treatment) and routine treatment (control).
Blinding (investigator's opinion)
Double blinded
Blinding description
Herbal medicine and placebo packaging is prepared with a label with code B or A. Other specifications on the labels are the same. Physicians, nurses, patients, data collectors, and those evaluating the outcome are unaware of the drug and placebo group. Patients are aware that they are in either the herbal group or the placebo group, but they do not know the type of group they are in.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Kermanshah University of Medical Science
Street address
Central building, Beheshti Blvd, Kermanshah University of Medical Science
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2021-10-19, 1400/07/27
Ethics committee reference number
IR.KUMS.REC.1400.544

Health conditions studied

1

Description of health condition studied
COVID-19
ICD-10 code
U07.1
ICD-10 code description
Covid-19

Primary outcomes

1

Description
Blood oxygen saturation
Timepoint
At the beginning and end of the study on a regular basis
Method of measurement
Pulse oximeter

2

Description
Rate of lung involvement
Timepoint
beginning and end of the study
Method of measurement
computed tomography scan

Secondary outcomes

1

Description
Number of breaths
Timepoint
At the beginning and end of the study on a regular basis
Method of measurement
Counting breaths per minute

2

Description
Body temperature
Timepoint
At the beginning and end of the study on a regular basis
Method of measurement
thermometer and clinical examination

3

Description
dyspnea
Timepoint
At the beginning and end of the study on a regular basis
Method of measurement
clinical examination

4

Description
cough
Timepoint
At the beginning and end of the study on a regular basis
Method of measurement
clinical examination

Intervention groups

1

Description
Intervention group: Patients in this group, in addition to receiving standard medications, use a syrup or nasal spray prepared from the mountain ghaziani plant, which is dried under normal conditions and prepared as a syrup and nasal spray three times a day for a week.
Category
Treatment - Drugs

2

Description
Control group: Routine treatment according to the latest update of the new national coronavirus treatment guidelines
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Farabi Hospital
Full name of responsible person
Hossein Amiri
Street address
Dowlatabad Blvd, Farabi Hospital, Kermanshah Province, Kermanshah
City
kermanshah
Province
Kermanshah
Postal code
67198 51151
Phone
+98 83 3727 2049
Email
hossein.amirii@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Reza KhodaRahmi
Street address
Shahid Beheshti Blvd., Kermanshah University of Medical Sciences
City
kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3838 4185
Email
rkhodarahmi@mbrc.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Hossein Amiri
Position
Non-faculty specialist physician
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Naghlieh Street - Imam Khomeini Hospital, Kermanshah
City
kermanshah
Province
Kermanshah
Postal code
6718743161
Phone
008337272049
Email
hossein.amirii@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Hossein Amiri
Position
Non-faculty specialist physician
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Naghlieh Street - Imam Khomeini Hospital, Kermanshah
City
kermanshah
Province
Kermanshah
Postal code
6718743161
Phone
008337272049
Email
hossein.amirii@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Reza Tahvilian
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
University Street, Parstar Blvd.
City
kermanshah
Province
Kermanshah
Postal code
6714415153
Phone
+98 83 3427 6480
Email
rtahvilian@kums.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
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
Title and more details about the data/document
The main consequences are shared after the intervention in the disease
When the data will become available and for how long
One year after the publication of the results
To whom data/document is available
Researchers, doctors and students
Under which criteria data/document could be used
For the use of other researchers
From where data/document is obtainable
Correspond with the project manager. Phone: 08337272049 Email: hossein.amirii@yahoo.com
What processes are involved for a request to access data/document
Request via email
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