Effect of Cinnamase drops on the incidence of clinical symptoms in asymptomatic individuals in the family of under treatment Covid 19 patients
Design
The present study is a randomized controlled clinical trial involving two groups of intervention and control which is performed in parallel, non-blind, randomized groups by SAS9.4 software on 100 patients.
Settings and conduct
The study site is Kian Asai Pars Health Promotion and Prevention Center.
By examining the PCR test, after a visit by a physician, individuals with the inclusion criteria complete an informed consent form. According to the table of random numbers, the intervention group received Cinnamaz drops and the control group did not receive medication.
At the end of the intervention in the first week and second week, participants will be monitored for clinical symptoms and COVID-19. and a questionnaire approved by infectious and lung diseases researchers is completed for both groups
Participants/Inclusion and exclusion criteria
Inclusion criteria for participants are: Definitive diagnosis of Covid 19 for a member of family based on clinical symptoms and positive PCR test result; Signing an informed consent form; No symptoms of Covid 19 from two weeks before the study; Do not participate in other clinical trials and exclusion criteria is allergy to herbal medicines and natural oils.
Intervention groups
Intervention group: 50 healthy persons in contact with the Covid-19 patient use one drop of Cinnamase oil (License number: 118880/665, the product of "Sanabel Daroo" company, prepared from Nigella sativa L. oil and Olea europaea L oil.) in each side of their nose twice a day for 7 days.
Control group: 50 healthy persons in contact with the Covid-19 patient do not take any complementary therapy during the study.
Main outcome variables
Clinical signs of coronavirus disease
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210515051305N1
Registration date:2021-07-10, 1400/04/19
Registration timing:registered_while_recruiting
Last update:2021-07-10, 1400/04/19
Update count:0
Registration date
2021-07-10, 1400/04/19
Registrant information
Name
Zahra Bahaeddin
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6646 4320
Email address
z.bahaedin@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-06-16, 1400/03/26
Expected recruitment end date
2022-05-22, 1401/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Cinnamase drops on the incidence of clinical symptoms in asymptomatic individuals in the family of under treatment Covid 19 patients
Public title
The effect of Cinnamase drops on family members of patients with Covid 19
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Definitive diagnosis of Covid 19 for a member of family based on clinical symptoms and positive PCR test result.
Signing consent form by volunteers participating in the study
Volunteers should not have Covid-19 symptoms for two weeks prior to the study
Volunteers should not participate in other clinical trials
Volunteers should not use supplements (containing vitamins, minerals and probiotics) or other preventive treatments.
Exclusion criteria:
Allergy to herbal medicines and and natural oils
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Eligible participants will be randomly assigned into 2 groups in a 1:1 ratio using block randomization method with a block length of 2 by PROC PLAN of SAS 9.4. An independent statistician generates the randomization number sequence. The drug codes will be attached after the manufacturing and packaging of the experiment treatment and placebo. The drugs will be allocated sequentially according to the screening order of the patients. Group assignment will be kept in an opaque and sealed envelope and will be opened after data analysis by another statistician.
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 Shahed University
Street address
Shahed University, In front of the holy shrine of Imam Khomeini, Qom freeway,Tehran , Iran.
City
Tehran
Province
Tehran
Postal code
3319118651
Approval date
2021-04-27, 1400/02/07
Ethics committee reference number
ir.shahed.rec.1400.014
Health conditions studied
1
Description of health condition studied
coronavirus disease
ICD-10 code
U07.1
ICD-10 code description
COVID-19, virus identified
Primary outcomes
1
Description
Clinical signs of coronavirus disease
Timepoint
Before starting the study,7,14 days after the start of the study
Method of measurement
Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 50 healthy persons in contact with the Covid-19 patient use one drop of Cinnamase oil in each side of their nose twice a day for 7 days. They should not take other complementary treatments during the study. The questionnaire is completed on days 0, 7 and 14. Cinnamase drops (License number: 118880/665) is the product of "Sanabel Daroo" company. This drug is a product derived from the knowledge of Iranian traditional medicine, which is scientifically prepared from Nigella sativa L. oil and Olea europaea L oil.
Category
Prevention
2
Description
Control group: 50 healthy people in contact with Covid-19 patients, who not taking any other complementary treatment during the study. The questionnaire is completed on days 0, 7 and 14.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Kian Asai Pars Health Promotion and Prevention Center
Full name of responsible person
Mohsen Naseri
Street address
No. 13, 1st Kouhestan, Pasdaran, Nobonyad Square, Tehran
City
Tehran
Province
Tehran
Postal code
1963846451
Phone
+98 21 2258 1764
Email
info@advancedmed.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahed University
Full name of responsible person
Zahra Kiasalari
Street address
Shahed University, In front of the holy shrine of Imam Khomeini, Qom freeway,Tehran , Iran.
City
Tehran
Province
Tehran
Postal code
1417953836
Phone
+98 21 6646 4320
Email
itmrc@shahed.ac.ir
Web page address
http://shahed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Traditional Medicine Clinical Trial Research Center, Shahed University, Tehran, Iran
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
Shahed University
Full name of responsible person
Mohsen Naseri
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
No.1471, North Kargar Street, Enghelab Square,Tehran , Iran.
City
Tehran
Province
Tehran
Postal code
1417953836
Phone
66464320
Email
naseri@shahed.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahed University
Full name of responsible person
Mohsen Naseri
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
No.1471, North Kargar Street, Enghelab Square,Tehran , Iran.
City
Tehran
Province
Tehran
Postal code
1417953836
Phone
66464320
Fax
Email
naserishahed@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahed University
Full name of responsible person
Mohsen Naseri
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
No.1471, North Kargar Street, Enghelab Square,Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1417953836
Phone
66464320
Email
naseri@shahed.ac.ir
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
The study has not yet begun. The data has not been collected yet and it will be decided later, but the results will be published
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
Not applicable
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available