Investigating the effect of Lavender (Lavandula angustifolia L.) syrup on improving the severity of cough in patients with definite or highly suspicious COVID-19
Investigating Lavender syrup efficacy to improve cough severity in definite or highly suspected COVID-19 patients
Design
Clinical trial with control group; with parallel groups; not blinded; randomized; phase 3 on 30 patients. Blocks of size 4 was used for randomization.
Settings and conduct
The study site is Kordkuy Amir-al-Momenin hospital affiliated to Golestan University of Medical Sciences.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Detection of mild to moderate COVID19.
Non-inclusion criteria: Need to be hospitalized; Sensitivity to lavender.
Intervention groups
Both groups receive supportive therapies based on conventional classical medicine protocols. Patients in the intervention group will be given lavender syrup twice a day for 2 weeks. Patients in the control group will not be prescribed any medication other than routine treatments.
Main outcome variables
Respiratory rate; Cough; Lethargy; body pain; Fever; Satisfaction with treatment; Anxiety
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20110907007511N4
Registration date:2020-07-25, 1399/05/04
Registration timing:registered_while_recruiting
Last update:2020-07-25, 1399/05/04
Update count:0
Registration date
2020-07-25, 1399/05/04
Registrant information
Name
Marzieh Qaraaty
Name of organization / entity
Golestan University of Medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 17 3254 1065
Email address
gharaaty1387@shahed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-05-16, 1399/02/27
Expected recruitment end date
2020-09-17, 1399/06/27
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of Lavender (Lavandula angustifolia L.) syrup on improving the severity of cough in patients with definite or highly suspicious COVID-19
Public title
Effect of Lavender syrup on COVID-19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 18 and 65 years
Conscious consent to participate in the study
Fever greater than 38 degrees or a feeling of hot flashes with at least one clinical sign of a dry cough, 24% number of breaths per minute, headache or body aches, feeling weak and lethargic, anosmia (olfactory disturbance) or taste disturbances, nausea
Seven days or less after the onset of symptoms at the first visit or relapse within 6 weeks of previous treatment
Absence of respiratory distress
Candidate for outpatient treatment
Exclusion criteria:
Need to be hospitalized
Pregnancy and lactation
Smoking
Underlying heart / liver /kidney disease / high blood pressure
Use other herbal medicines to control the symptoms of the disease
Sensitivity to lavender
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization: According to the random list resulting from block randomization using blocks of size 4 is done.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Fall criteria: - Sensitivity to lavender - Lack of proper use of prescribed drugs (less than 80%) - Drug side effects - Exacerbation of symptoms and the need for hospitalization
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Golestan University of Medical Sciences
Street address
Shadravan Falsafi Higher Education Complex; at the beginning of Shast Kola road
City
Gorgan
Province
Golestan
Postal code
14395-477
Approval date
2020-05-03, 1399/02/14
Ethics committee reference number
IR.GOUMS.REC.1399.025
Health conditions studied
1
Description of health condition studied
COVID-19
ICD-10 code
U07.1
ICD-10 code description
COVID-19, virus identified
2
Description of health condition studied
COVID-19
ICD-10 code
U07.2
ICD-10 code description
COVID-19, virus not identified
Primary outcomes
1
Description
Changes in the severity of cough
Timepoint
Follow-up of patients in zero step (at the beginning of the study as a face-to-face visit), the first step (7 days after entering the study by telephone follow-up), the second step (14 days after entering the study by telephone follow-up), the third time (21 days after entering the study by telephone follow-up), the fourth time (14 days after the end of the study by telephone follow-up) and the fifth time (28 days after the end of the study by telephone follow-up)
Method of measurement
Checklist of patient and disease characteristics, satisfaction with treatment by asking general questions, assessment of patient symptoms based on Visual Analogue Scale (10 points)
2
Description
Changes in the severity of fever
Timepoint
Follow-up of patients in zero step (at the beginning of the study as a face-to-face visit), the first step (7 days after entering the study by telephone follow-up), the second step (14 days after entering the study by telephone follow-up), the third time (21 days after entering the study by telephone follow-up), the fourth time (14 days after the end of the study by telephone follow-up) and the fifth time (28 days after the end of the study by telephone follow-up)
Method of measurement
Checklist of patient and disease characteristics, satisfaction with treatment by asking general questions, assessment of patient symptoms based on Visual Analogue Scale (10 points)
3
Description
Change in the severity of shortness of breath
Timepoint
Follow-up of patients in zero step (at the beginning of the study as a face-to-face visit), the first step (7 days after entering the study by telephone follow-up), the second step (14 days after entering the study by telephone follow-up), the third time (21 days after entering the study by telephone follow-up), the fourth time (14 days after the end of the study by telephone follow-up) and the fifth time (28 days after the end of the study by telephone follow-up)
Method of measurement
Checklist of patient and disease characteristics, satisfaction with treatment by asking general questions, assessment of patient symptoms based on Visual Analogue Scale (10 points)
Secondary outcomes
1
Description
Quality of Life
Timepoint
Follow-up of patients in zero step (at the beginning of the study as a face-to-face visit), the first step (7 days after entering the study by telephone follow-up), the second step (14 days after entering the study by telephone follow-up), the third time (21 days after entering the study by telephone follow-up), the fourth time (14 days after the end of the study by telephone follow-up) and the fifth time (28 days after the end of the study by telephone follow-up)
Method of measurement
Short questionnaire 12 questions SF12
2
Description
Satisfaction with treatment
Timepoint
Follow-up of patients in zero step (at the beginning of the study as a face-to-face visit), the first step (7 days after entering the study by telephone follow-up), the second step (14 days after entering the study by telephone follow-up), the third time (21 days after entering the study by telephone follow-up), the fourth time (14 days after the end of the study by telephone follow-up) and the fifth time (28 days after the end of the study by telephone follow-up)
Method of measurement
Asking general questions
3
Description
Anxiety
Timepoint
Follow-up of patients in zero step (at the beginning of the study as a face-to-face visit), the first step (7 days after entering the study by telephone follow-up), the second step (14 days after entering the study by telephone follow-up), the third time (21 days after entering the study by telephone follow-up), the fourth time (14 days after the end of the study by telephone follow-up) and the fifth time (28 days after the end of the study by telephone follow-up)
Method of measurement
Based on the Hamilton Questionnaire
Intervention groups
1
Description
Intervention group: Supportive treatments related to the control of fever, pain, cough and other symptoms will be prescribed according to the common COVID-19 protocols in classical medicine. Also, in the intervention group receive 9 mL of lavender syrup twice a day for 14 days in addition to routine treatments (18 mL daily). Lavender syrup is prepared as follows:100 g of dried lavender branch (Lavandula angustifolia L.) is washed, then soaked in 1000 mL of water for 3 hours. It is then boiled for 10 min and the resulting liquid is cooled in the laboratory. After cooling, the contents of the container are concentrated with a smooth filter and the resulting product is concentrated. From the obtained dry extract, we make 5 g to 100 g using the USP syrup making model with 66.7 g of honey and 28.5 g of water. The resulting syrup is poured into 120 mL sterile jars, sealed and sterilized by autoclave.
Category
Treatment - Drugs
2
Description
Control group:Supportive treatments related to the control of fever, pain, cough and other symptoms will be prescribed according to the common COVID-19 protocols in classical medicine.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Golestan Medical Sciences Hospitals
Full name of responsible person
Dr. Marzieh Qaraati
Street address
Shastkola Road
City
Gorgan
Province
Golestan
Postal code
14395-477
Phone
+98 17 3245 1434
Fax
+98 17 3245 1434
Email
Dr.qaraati@goums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Dr. Marzieh Qaraati
Street address
Shastkola Road
City
Gorgan
Province
Golestan
Postal code
14395-477
Phone
+98 17 3245 1434
Fax
+98 17 3245 1434
Email
Dr.qaraati@goums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gorgan 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
Gorgan University of Medical Sciences
Full name of responsible person
Dr. Marzieh Qaraati
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Shastkola Road
City
Gorgan
Province
Golestan
Postal code
14395-477
Phone
+98 17 3245 1434
Email
Dr.qaraati@goums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Marzieh Qaraati
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Shastkola Road
City
gorgan
Province
Golestan
Postal code
14395-477
Phone
+98 17 3245 1434
Email
Dr.qaraati@goums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Dr. Marzieh Qaraati
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Shastkola Road
City
gorgan
Province
Golestan
Postal code
14395-477
Phone
+98 17 3245 1434
Fax
+98 17 3245 1434
Email
Dr.qaraati@goums.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