The effect of nebulizing Peppermint extract and Rose extract on percentage of blood oxygen saturation in patients with COVID-19
Design
Patient candidate for with evidences of COVID-19 in chest CT Scan and candidate for hospitalizing randomly and with using table of random number divided in 3 groups and each group contain 20 individuals. Groups; Peppermint group, Rose oil group and control's group. Sample size 60 was determined that divided in 3 groups. Clinical trial, single blind, with control group.
Settings and conduct
Patients with evidences of COVID-19 in chest CT Scan and candidate for hospitalizing in Shohadaye Tajrish hospital divided in groups and participants have no information about groups and receiving medication or placebo.
Participants/Inclusion and exclusion criteria
Patients with evidence of COVID-19 in Chest CT Scan
Without history of Asthma or Chronic Obstruction Pulmonary Disease
Without history of Allergy
Intervention groups
Three groups; The first group receive nebulizing of peppermint extract and the second group receive nebulizing of Rose extract and the third group (control) receive nebulizing of distilled water as placebo.
Main outcome variables
Percentage of blood oxygen saturation in patients with COVID-19
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190131042569N5
Registration date:2020-08-23, 1399/06/02
Registration timing:registered_while_recruiting
Last update:2020-08-23, 1399/06/02
Update count:0
Registration date
2020-08-23, 1399/06/02
Registrant information
Name
Nima saeedi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2641 8939
Email address
nimasaeedi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-29, 1399/04/09
Expected recruitment end date
2020-09-21, 1399/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of nebulizing Peppermint extract and Rose extract on percentage of blood oxygen saturation in patients with COVID-19
Public title
The effect of nebulizing Peppermint extract and Rose extract on percentage of blood oxygen saturation in patients with COVID-19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with evidence of COVID-19 in Chest CT Scan
Age between 30 and 60 years
Exclusion criteria:
History of Asthma or Chronic Obstruction Pulmonary Disease
History of Allergy
Age
From 30 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Each patient who qualify for inclusion after completing the consent form is assigned by the person in charge of this process using a random number table from 1 to 60 ( 1- 20 Peppermint group, 21-40 Rose oil group and 41-60 control group) where the person is placed on one of the numbers and assigned to one of the 2 specified groups. (Simple randomization by individual using random number table).
Blinding (investigator's opinion)
Single blinded
Blinding description
The person responsible for follow-up and recordings data has no information about the patient's group.
Placebo
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
Shahid Beheshti University of Medical Science, Arabi Ave., Daneshjoo Blvd., Velenjak, Tehran.
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2020-06-28, 1399/04/08
Ethics committee reference number
IR.SBMU.RETECH.REC.1399.353
Health conditions studied
1
Description of health condition studied
COVID-19
ICD-10 code
U07.1
ICD-10 code description
COVID-19, virus identified, confirmed by laboratory testing
Primary outcomes
1
Description
Increasing of percentage of blood oxygen saturation
Timepoint
Measurement of blood oxygen saturation percentage at the beginning of the study, the first day, the second day and the third day of treatment
Method of measurement
Pulse oximetry
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1 : From the beginning of treatment, patients receive Nebulizing of Peppermint extract from Barij Essence brand (15 drops in 30 cc of distilled water) daily and each time for 2 hours for 3 days.
Category
Rehabilitation
2
Description
Intervention group 2 : From the beginning of treatment, patients receive Nebulizing of Rose extract from Barij Essence brand (15 drops in 30 cc of distilled water) daily and each time for 2 hours for 3 days.
Category
Rehabilitation
3
Description
Control group: From the beginning of treatment, patients receive Nebulizing of distilled water(30 cc) daily and each time for 2 hours for 3 days.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shohadaye Tajrish Hospital
Full name of responsible person
Nima Saeedi
Street address
Shohadaye Tajrish Hospital, Tajrish Square, Tehran
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 25719
Email
pr_shohada@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Department of Shahid Beheshti University of Medical Sciences
Full name of responsible person
Seyed Ali Ziayi
Street address
Third floor, School of Medicine, near the Taleghani Hospital, Evin, Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
1985717434
Phone
+98 21 2243 9951
Fax
Email
mpd@sbmu.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Department of 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
Nima Saeedi
Position
Anesthesia assistance
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
No. 11, First East Ave., Bistochahar metri Ave., Tehran.
City
Tehran
Province
Tehran
Postal code
1997778416
Phone
+98 21 2641 8939
Fax
Email
nimasaeedi7@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Nima Saeedi
Position
Anesthesia assistance
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
No. 11, First East Ave., Bistochahar metri Ave., Tehran.
City
Tehran
Province
Tehran
Postal code
1997778416
Phone
+98 21 2641 8939
Fax
Email
nimasaeedi7@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Nima Saeedi
Position
Anesthesia assistance
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
No. 11, First East Ave., Bistochahar metri Ave., Tehran.
City
Tehran
Province
Tehran
Postal code
1997778416
Phone
+98 21 2641 8939
Fax
Email
nimasaeedi7@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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Participant data (age, percentage of blood oxygen saturation and type of patient's group) are to be shared.
When the data will become available and for how long
1 year after publication
To whom data/document is available
Researchers working in academic institutions
Under which criteria data/document could be used
Using data and analysis for use in academic research