Comparison of the effect of Mentha Piperita and Rosmarinus Officinalis on pain, weakness and fatigue in patients with COVID-19
Design
A clinical trial with a control group with parallel groups, one-way blind, randomized, on 120 patients. Excel software rand function is used for randomization.
Settings and conduct
Patients with Covid-19 are identified through health centers dedicated to receiving and visiting coronary patients. The researcher then contacts the selected samples and, if they are allow, goes to the patients' house to provide the relevant forms as well as herbal sweat and a 100 cc glass and provide the necessary training. The researcher will contact the samples daily and remind them about consuming herbal sweat and completing the forms. The researcher's phone number is also provided to the samples to answer their questions if needed. The researcher returned to the patients' house on the fourth day to collect all the forms.
Participants/Inclusion and exclusion criteria
Patients aged 15-70 years who have been diagnosed with Covid-19 disease by PCR or CT scan of the lung and have symptoms of pain, weakness and fatigue.
Exclusion criteria include pregnancy or lactation, sensitivity to herbal medicines
Intervention groups
Peppermint group: Consume 100 cc of bottled liquid 3 times a day for 3 days, using a graduated glass that is provided with a bottle of peppermint sweat.
Rosemary group: Consume 100 cc of bottle liquid 3 times a day for 3 days, using a graduated glass that is provided with a bottle of rosemary sweat.
Placebo group: Consume 100 cc of bottle liquid 3 times a day for 3 days, using a graduated glass that is provided with a bottle of water.
Control group: No intervention is performed
Main outcome variables
pain; Weakness; Fatigue
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20110430006342N11
Registration date:2021-06-28, 1400/04/07
Registration timing:registered_while_recruiting
Last update:2021-06-28, 1400/04/07
Update count:0
Registration date
2021-06-28, 1400/04/07
Registrant information
Name
Ali Asghar Ghods
Name of organization / entity
Semnan Universioty of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 23 1335 4192
Email address
aaghods@sem-ums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-06-22, 1400/04/01
Expected recruitment end date
2021-08-23, 1400/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of Mentha Piperita and Rosmarinus Officinalis on pain, weakness and fatigue in patients with COVID-19
Public title
Comparison of the effect of Mentha Piperita and Rosmarinus Officinalis on pain, weakness and fatigue in patients with COVID-19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with Covid-19
Having body aches
Having weakness
Having fatigue
Exclusion criteria:
Pregnant women
Breastfeeding women
Allergy to herbal medicines
Age
From 15 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are randomly divided into four groups: peppermint, rosemary, placebo and control. For each block of four, one of 24 possible modes is randomly selected
Blinding (investigator's opinion)
Single blinded
Blinding description
Patients know that they are randomly given one of herbal sweat or water. Herbal sweat or placebo is provided to patients in identical and unlabeled containers
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Semnan University of Medical Sciences and Health Services
Street address
Headquarters of Semnan University of Medical Sciencesو, Basij Boulevard
City
Semnan
Province
Semnan
Postal code
3519711111
Approval date
2021-05-25, 1400/03/04
Ethics committee reference number
IR.SEMUMS.REC.1400.040
Health conditions studied
1
Description of health condition studied
covid-19
ICD-10 code
U07.1
ICD-10 code description
COVID-19, virus identified
Primary outcomes
1
Description
Pain score on the visual analog scale of pain
Timepoint
Before intervention, 24, 48 and 72 hours after intervention
Method of measurement
Visual Analogue Scale
2
Description
Weakness score on visual analog scale
Timepoint
Before intervention, 24, 48 and 72 hours after intervention
Method of measurement
Visual Analogue Scale
3
Description
Fatigue score
Timepoint
Before intervention, 24, 48 and 72 hours after intervention
Method of measurement
Fatigue severity scale (FSS)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Peppermint Sweat Made byYaghoot Company 100 cc three times a day for three consecutive days
Category
Treatment - Other
2
Description
Intervention group: Rosmarinus Sweat Made by Yaghoot Company 100 cc three times a day for three consecutive days
Category
Treatment - Other
3
Description
Intervention group: Placebo. Water is used . Three times a day for three days
Category
Placebo
4
Description
Control group: No intervention is performed
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Health center of 17-shahrivar
Full name of responsible person
Reyhaneh Molakazemi
Street address
Headquarters of Semnan University of Medical Sciences, Basij Boulevard
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3344 8996
Email
noble.1400@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Parviz Kokhaee
Street address
Headquarters of Semnan University of Medical Sciences, Basij Boulevard
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3344 8996
Email
p_kokha@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan 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
Semnan University of Medical Sciences
Full name of responsible person
Ali Asghar Ghods
Position
Faculty Member
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Semnan University of Medical Sciences, Basij Boulevard
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3344 8996
Email
aaghods@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Ali Asghar Ghods
Position
Faculty Member
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Semnan University of Medical Sciences, Basij Boulevard
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3344 8996
Email
aaghods@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Ali Asghar Ghods
Position
Faculty Member
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Semnan University of Medical Sciences, Basij Boulevard
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3344 8996
Email
aghods@yahoo.com
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
Yes - There is 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
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Statistical results and data analysis will be published
When the data will become available and for how long
Six months to one year after sampling
To whom data/document is available
The results are published in one of the prestigious journals. Researchers working in academic and scientific institutions can access it
Under which criteria data/document could be used
To be aware of research results. Academic researchers can use published material by citing the source
From where data/document is obtainable
Information can be obtained by email or mailing address of the responsible author.
What processes are involved for a request to access data/document
The applicant can request information by introducing him/herself. The required answer will be given within two weeks.