Protocol summary

Study aim
The effect of garlic and cinnamon on the treatment of corona (COVID-19) patients
Design
Due to the fact that no study has been done in this field so far, 45 people are divided into 3 groups of 16 people, so that from 1 to 45, it is already determined that they are a drug or placebo group. Then, in order of entering the study, people select the numbers and are placed in their group.
Settings and conduct
The study is performed on coronary patients admitted to Sabzevar Vasei Hospital. Sampling is based on the target and participants are randomly assigned a 1: 1: 1 ratio in two treatment groups: garlic, cinnamon, and without intervention. The criteria for evaluating treatment is: VAS scale (100 mm standard) .The amount of headache and body pain of the patient before the intervention, during and at the end of the study will be measured. Each 10 drops of Garlic contains 250 grams of garlic extract. And three times a day, 10 drops are taken with food or water each time. Consumption of cinnamon drops twice a day, each time 7 drops of this product is poured into a glass of water or tea and consumed.
Participants/Inclusion and exclusion criteria
Inclusion criteria include all patients with coronavirus who had a positive RT-PCR test, and Exclusion criteria for patients with allergies to garlic and cinnamon, patients with anticoagulants, diabetes, insomnia, pemphigus, organ transplantation, asthma, pregnancy.
Intervention groups
Garlic and Cinnamon
Main outcome variables
Reduce the symptoms of the disease

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200705048011N1
Registration date: 2020-08-16, 1399/05/26
Registration timing: prospective

Last update: 2020-08-16, 1399/05/26
Update count: 0
Registration date
2020-08-16, 1399/05/26
Registrant information
Name
nasrin fazel
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 4401 8301
Email address
shohreh1368@yahoo.co.uk
Recruitment status
recruiting
Funding source
Expected recruitment start date
2020-08-22, 1399/06/01
Expected recruitment end date
2021-03-19, 1399/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of garlic and cinnamon essential oil on the treatment of patients with corona (COVID-19)
Public title
Garlic and cinnamon on the treatment of patients with corona
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Inclusion criteria include all patients with corona virus who had a positive RT-PCR test.
Exclusion criteria:
Exclusion criteria for patients with corona negative test Those who are not willing to continue participating in the study. Patients with allergies to garlic and cinnamon, Patients taking anticoagulants, having diabetes, Insomnia, Pemphigus, asthma, Transplantation, Pregnancy.
Age
From 10 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 45
Randomization (investigator's opinion)
Not randomized
Randomization description
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 Sabzevar University of Medical sciences
Street address
No. 2, Tohid Shahr Ave, Campus University Building, Sabzevar
City
Sabzevar
Province
South Khorasan
Postal code
9613873136
Approval date
2020-07-08, 1399/04/18
Ethics committee reference number
ir.medsab.rec.1399.072

Health conditions studied

1

Description of health condition studied
Covid-19
ICD-10 code
B34.2
ICD-10 code description
Coronavirus infection, unspecified

Primary outcomes

1

Description
Headache
Timepoint
The first day and the last day of the intervention
Method of measurement
Visual Analogue Scale

2

Description
Body pain
Timepoint
The first day and the last day of the intervention
Method of measurement
Visual Analogue Scale

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Recipient of garlic essential oil. Patients in the intervention group will take the drug prepared from garlic for 1 week. A drop of garlic made by Amin Pharmaceutical Company is consumed ten drops daily for a week. Each 10 drops of Garlic contains 250 grams of garlic extract. It should be noted that patients will receive routine medication for coronary artery disease. The trained nurse will perform the intervention.
Category
Other

2

Description
Control group: No intervantion
Category
Other

3

Description
Intervention group: Intervention group: Recipients of cinnamon essential oil. Patients of the second intervention group will take cinnamon medicine for 1 week. Cinnamon drops made by Zardband pharmaceutical company .It will be use three times a day and 5 drops in a glass of water, tea each time. It should be noted that patients will receive routine medication for the treatment of coronary heart disease.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Vasei hospital
Full name of responsible person
Nasrin Fazel
Street address
No 2.Tohid Shahr Ave, Campus University Building,Sabzevar
City
Sabzevar
Province
Razavi Khorasan
Postal code
9613873136
Phone
+98 51 4401 4000
Email
vasei.H@medsab.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Dr.Fereshte Ghorat
Street address
No 2,Tohid Shahr Ave, Campus University Building,Sabzevar
City
Sabzevar
Province
Razavi Khorasan
Postal code
9613873136
Phone
+98 51 4401 1000
Email
vc.education@medsab.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Sabzevar Medical 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
Sabzevar University of Medical Sciences
Full name of responsible person
Nasrin Fazel
Position
Academic member
Latest degree
Master
Other areas of specialty/work
Gynecology and Obstetrics
Street address
No 2,Tohid Shahr Ave, Campus University Building,Sabzevar
City
Sabzevar
Province
Razavi Khorasan
Postal code
9613873136
Phone
+98 51 4401 1000
Email
shohreh1368@yahoo.co.uk

Person responsible for scientific inquiries

Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Nasrin Fazel
Position
Academic member
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
No 2,Tohid Shahr Ave, Campus University Building,Sabzevar
City
Sabzevar
Province
Razavi Khorasan
Postal code
96138731366
Phone
+98 51 4401 8301
Email
shohreh1368@yahoo.co.uk

Person responsible for updating data

Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Nasrin Fazel
Position
Academic member
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
No 2,Tohid Shahr Ave, Campus University Building,Sabzevar
City
Sabzevar
Province
South Khorasan
Postal code
9613873136
Phone
+98 51 4401 8301
Email
shohreh1368@yahoo.co.uk

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
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
No - There is not a plan to make this available
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