Determination of The Effect of Inhalation of Thyme Oil with Standard Nationwide Medication on Respiratory Markers and Laboratory Findings in Patients with COVID-19
Design
A clinical trial with a control group, with parallel groups, double-blind, randomized block, phase 2-3 on 48 patients. Random chains and concealment codes were produced by the website "www.sealedenvelope.com".
Settings and conduct
This randomized double-blind study was performed at Khatam al-Anbia hospital in Shoushtar. The standard nationwide medication + Intervention Group receives pure thyme essential oil through a nebulizer (every 8 hours for 30 minutes) for 5 days. Also, the control group receives a standard nationwide medication + 10 cc of distilled water as a placebo through a nebulizer (every 8 hours for 30 minutes) for 5 days. All research teams except the lead researcher and the treating physician will be blind, and the information will be given to the analyzer by the treating physician with a special code extracted from the table of random numbers.
Participants/Inclusion and exclusion criteria
Age over 18 years; Mild to moderate disease; Positive polymerase chain reaction (PCR) test; Lung involvement based on CT scan; Hospitalization
Intervention groups
The intervention group in addition to receiving standard nationwide medication receives pure thyme oil every 8 hours for 30 minutes through a nebulizer for 5 days. Also, the Control group in addition to receiving standard nationwide medication receives 10 cc of distilled water (placebo) every 8 hours for 30 minutes through a nebulizer for 5 days. The standard nationwide medication is as follows: 2 tablets of Hydroxychloroquine sulfate 200 mg as a single dose and 2 tablets of Kaletra (Lopinavir/Ritonavir) 200/200 mg every 12 hours
Main outcome variables
Percentage of oxygen saturation; Respiratory rate
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200426047212N1
Registration date:2020-05-02, 1399/02/13
Registration timing:prospective
Last update:2020-05-02, 1399/02/13
Update count:0
Registration date
2020-05-02, 1399/02/13
Registrant information
Name
Ali Hatami
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3668 7153
Email address
hatami_a@shoushtarums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-05-04, 1399/02/15
Expected recruitment end date
2020-07-05, 1399/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Inhalation of Thyme Oil with Standard Nationwide Medication on Respiratory Markers and Laboratory Findings in Patients with COVID-19
Public title
Effect of of Inhalation of Thyme Oil in COVID-19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 18 years
Mild to moderate disease
Positive polymerase chain reaction (PCR) test
Lung involvement based on CT scan
Hospitalization
Exclusion criteria:
Patient death
Sensitivity to inhalation of the drug
Intolerance of nebulizer
Physician's diagnosis of not participating in the study
Pregnancy and lactation
Use of angiotensin-converting enzyme inhibitor
Severe renal, hepatic, respiratory and cardiovascular failure
Taking cytotoxic or corticosteroid drugs
Transfer to another hospital
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Data analyser
Sample size
Target sample size:
48
Randomization (investigator's opinion)
Randomized
Randomization description
Allocation of samples to each of the intervention and control groups was performed by block random method using 4 blocks. Random chains and concealment codes were generated by the website "www.sealedenvelope.com". To hide the random chain, the method of envelopes in non-transparent packages is also used.
Blinding (investigator's opinion)
Double blinded
Blinding description
Thyme oil and placebo oil is imported in uniform bottles of the same color and is given to patients and clinical caregivers in envelopes A and B. Thyme oil does not have a special smell and using the allowed color, the placebo is the same color as the medicine. All research teams except the lead researcher and the treating physician will be blind, and the information will be given to the analyzer by the treating physician with a special code extracted from the table of random numbers.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shoushtar Faculty of Medical Sciences
Street address
Shahid Rajaei Ave., Al-Hadi Hospital, Education, Research, Cultural and Student Department of Shushtar Faculty of Medical Sciences
City
Shoushtar
Province
Khouzestan
Postal code
6451684534
Approval date
2020-04-22, 1399/02/03
Ethics committee reference number
IR.SHOUSHTAR.REC.1399.005
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
Percentage of oxygen saturation
Timepoint
Before the start of the intervention, 5 consecutive days during the intervention and one day after the intervention
Method of measurement
Pulse oximeter
2
Description
Respiratory rate
Timepoint
Before the start of the intervention, 5 consecutive days during the intervention and one day after the intervention
Method of measurement
Count the respiratory rate per minute
Secondary outcomes
1
Description
C-Reactive Protein
Timepoint
Before the intervention and one day in between during the intervention until discharge
Method of measurement
Venous blood test
2
Description
White blood cell
Timepoint
Before the intervention and one day in between during the intervention until discharge
Method of measurement
Venous blood test
3
Description
Neutrophil
Timepoint
Before the intervention and one day in between during the intervention until discharge
Method of measurement
Venous blood test
4
Description
Lymphocytes
Timepoint
Before the intervention and one day in between during the intervention until discharge
Method of measurement
Venous blood test
5
Description
Red blood count
Timepoint
Before the intervention and one day in between during the intervention until discharge
Method of measurement
Venous blood test
6
Description
Erythrocyte sedimentation rate
Timepoint
Before the intervention and one day in between during the intervention until discharge
Method of measurement
Venous blood test
Intervention groups
1
Description
Intervention group: The intervention group in addition to receiving a standard nationwide medication [2 tablets of Hydroxychloroquine sulfate 200 mg as a single dose and 2 tablets of Kaletra(Lopinavir/Ritonavir) 200/200 mg every 12 hours], receives pure thyme oil every 8 hours (8 am, 4 pm, 12 pm) for 30 minutes through a nebulizer for 5 days. So that 4 drops of pure thyme oil with 10 cc of distilled water were prepared for each nebulization.
Category
Treatment - Drugs
2
Description
Control group: The control group in addition to receiving a standard nationwide medication [2 tablets of Hydroxychloroquine sulfate 200 mg as a single dose and 2 tablets of Kaletra(Lopinavir/Ritonavir) 200/200 mg every 12 hours], receives 10 cc of distilled water (placebo) every 8 hours (8 am, 4 pm, 12 pm) for 30 minutes through a nebulizer for 5 days.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Khatam al-Anbiya hospital
Full name of responsible person
Hassan Hassanzadeh Namin
Street address
Ammar Ave., Jazayeri Blvd., First of Farhang City
City
Shoushtar
Province
Khouzestan
Postal code
6451684534
Phone
+98 61 3623 3890
Email
hatami_a@shoushtarums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shooshtar University of Medical Sciences
Full name of responsible person
Barat Barati
Street address
Shahid Rajaei Ave., Al-Hadi Hospital, Education, Research, Cultural and Student Department of Shushtar Faculty of Medical Sciences
City
Shoushtar
Province
Khouzestan
Postal code
6451684534
Phone
+98 61 3622 8926
Email
barati-b@shoushtarums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shooshtar 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
Shooshtar University of Medical Sciences
Full name of responsible person
Ali Hatami
Position
Staff
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Shahid Rajaei Ave., Al-Hadi Hospital, Education, Research, Cultural and Student Department of Shushtar Faculty of Medical Sciences
City
Shoushtar
Province
Khouzestan
Postal code
6451684534
Phone
+98 61 3622 8926
Email
hatami_a@shoushtarums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shooshtar University of Medical Sciences
Full name of responsible person
Mohammad Nikzadian
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Shahid Rajaei Ave., Al-Hadi Hospital, Education, Research, Cultural and Student Department of Shushtar Faculty of Medical Sciences
City
Shoushtar
Province
Khouzestan
Postal code
6451684534
Phone
098 61 36228926
Email
nikzadian-m@shoushtarums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shooshtar University of Medical Sciences
Full name of responsible person
Ali Hatami
Position
Staff
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Shahid Rajaei Ave., Al-Hadi Hospital, Education, Research, Cultural and Student Department of Shushtar Faculty of Medical Sciences
City
Shoushtar
Province
Khouzestan
Postal code
6451684534
Phone
+98 61 3622 8926
Email
hatami_a@shoushtarums.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