Protocol summary

Study aim
Determining the effect of inhaling orange peel and peppermint essence on reducing the severity of COVID-19 symptoms in outpatients referred to clinic with a positive result of lung CT scan
Design
Clinical trial included of control group, without blinding, randomized and phase 3 on 60 patients. Randomize Allocation Software was used for randomization.
Settings and conduct
After completing a questionnaire and interview, checklist , CT scan and physical examination the patients with COVID-19 symptoms , were given the medication in the control group and placebo in the case group with the training how to perform the protocol .These steps happened again in 72 hours and a week later.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Pulmonary involvement on CT scan suspected to covid-19 disease, Having suspected clinical signs of covid-19 disease, Informed consent to participate in the study, Availability to incense the solution, Availability to visit after 72 hours, No need for hospitalization at the time of referrals Non Inclusion: Hospitalization, Non-pulmonary symptoms
Intervention groups
In the intervention group, a combination of orange peel and peppermint essence is given in a dropper bottle. People should pour 20 drops of this solution into a glass of water and boil it in a metal container on a pot and inhale its steam. In the control group, patients will receive their routine medications and use only incense in a glass of boiled water as a placebo.
Main outcome variables
Fever, Dyspnea, Tachypnea, Cough, Diarrhea, Myalgia, Headache, Rash, Tachycardia, Chest pain, SPO2, CT Scan result

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20110302005952N2
Registration date: 2020-12-17, 1399/09/27
Registration timing: registered_while_recruiting

Last update: 2020-12-17, 1399/09/27
Update count: 0
Registration date
2020-12-17, 1399/09/27
Registrant information
Name
Masoud Hafizi esfahani
Name of organization / entity
Shahrekord University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 38 1222 0016
Email address
hafizi@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-11-25, 1399/09/05
Expected recruitment end date
2020-12-25, 1399/10/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of inhalation of orange peel and peppermint extract on reducing the severity of COVID-19 symptoms in patients referred to clinic with a positive result of lung CT scan
Public title
The effect of orange peel and peppermint extract in coronavirus treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Pulmonary involvement on CT scan suspected to COVID-19 disease Having suspected clinical signs of COVID-19 disease Informed consent for participating in the study Possibility to visit after 72 hours No need for hospitalization at the time of referral Possibility of inhaling the solution
Exclusion criteria:
Hospitalized patient Non-respiratory symptoms suspected to COVID-19 disease
Age
From 10 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Shahrekord University of Medical Sciences
Street address
Bldg No. 2, Kahani Blvd, University Headquarter
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
۸۸۱۵۷۱۳۴۷۱
Approval date
2020-07-12, 1399/04/22
Ethics committee reference number
IR.SKUMS.REC.1399.107

Health conditions studied

1

Description of health condition studied
COVID-19
ICD-10 code
U07.2
ICD-10 code description
U07.2 COVID-19, virus not identified

Primary outcomes

1

Description
Fever
Timepoint
72 hours and one week after the first visit
Method of measurement
Thermometer

2

Description
Dyspnea
Timepoint
72 hours and one week after the first visit
Method of measurement
Non - Mild - Moderate - Severe

3

Description
Tachypnea
Timepoint
72 hours and one week after the first visit
Method of measurement
Inspiration/Minute

4

Description
Cough
Timepoint
72 hours and one week after the first visit
Method of measurement
Non - Mild - Moderate - Severe

5

Description
Diarrhea
Timepoint
72 hours and one week after the first visit
Method of measurement
Non - Mild - Moderate - Severe

6

Description
Myalgia
Timepoint
72 hours and one week after the first visit
Method of measurement
Visual Analogue Scale

7

Description
Headache
Timepoint
72 hours and one week after the first visit
Method of measurement
Visual Analogue Scale

8

Description
Rash
Timepoint
72 hours and one week after the first visit
Method of measurement
Visual Analogue Scale

9

Description
Tachycardia
Timepoint
72 hours and one week after the first visit
Method of measurement
Visual Analogue Scale

10

Description
Chest Pain
Timepoint
72 hours and one week after the first visit
Method of measurement
Visual Analogue Scale

11

Description
SPO2
Timepoint
72 hours and one week after the first visit
Method of measurement
Visual Analogue Scale

12

Description
CT Scan Result
Timepoint
One week after the first visit
Method of measurement
Visual Analogue Scale

Secondary outcomes

1

Description
Increasing the SPO2 with taking medication
Timepoint
72 hours and one week after the first visit
Method of measurement
Pulse Oximeter

2

Description
Shortening the Illness duration
Timepoint
72 hours and one week after the first visit
Method of measurement
Time Interval

3

Description
Reducing Pulmonary Inflammation
Timepoint
72 hours and one week after the first visit
Method of measurement
Visual Analogue Scale

Intervention groups

1

Description
Intervention group: The extract prepared from 14 cc of orange peel essential oil prepared from Ramsar Citrus Cooperative and 2 cc of peppermint essential oil in a 20 cc dropper bottle along with the instruction sheet is given to the patient. The patient will be trained to pour 20 drops of this solution in a glass of water and boil it in a metal container on a pot and inhale its steam (incense) and to do this three times a day until the medicine is finished.
Category
Treatment - Drugs

2

Description
Control group: Pour a glass of water in a metal container and boil it on a pot and breathe its steam (incense). Do this three times a day until the medicine is finished.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Clinic No.1, Social Security
Full name of responsible person
Mohammadali Ghiasi
Street address
Moulavi Ave
City
Sharekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8817686135
Phone
+98 38 3225 2341
Fax
Email
vahid_ghiaci@yahoo.com

2

Recruitment center
Name of recruitment center
Hajar Respiratory Clinic
Full name of responsible person
Masoud Hafizi Isfahani
Street address
Parastar Ave
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8816754633
Phone
+98 38 3222 5505
Fax
+98 38 3224 3715
Email
hafizi@skums.ac.ir
Web page address

3

Recruitment center
Name of recruitment center
Ali Asghar Clinic
Full name of responsible person
Reza Imani
Street address
Alley No. 31, 17 Shahrivar Ave
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8814855116
Phone
+98 38 3335 0993
Email
imanir46@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Mehraban Sadeghi
Street address
Bldg No.2, Kashani Blvd, University Headquarter
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
+98 38 3334 2414
Email
vcrt@skums.ac.ir
Web page address
https://research.skums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahre-kord 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
Social Security
Full name of responsible person
Mohammadali Ghiasi
Position
Specialized Physician
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Molavi Ave, Clinic No.1, Social Security
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8817686135
Phone
+98 38 3225 2341
Email
vahid_ghiaci@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Social Security
Full name of responsible person
محمدعلی غیاثی
Position
Specialized Physician
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Molavi Ave, Clinic No.1, Social Security
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8817686135
Phone
+98 38 3225 2341
Email
vahid_ghiaci@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Masoud hafizi isfahani
Position
Specialized Physician
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
Parastar Ave, Hajar Hospital
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8816754633
Phone
+98 38 3222 5505
Fax
+98 38 3224 3715
Email
hafizi@skums.ac.ir

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
Undecided - It is not yet known if there will be a plan to make this available
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