Determining the effect of olive leaf extract on clinical and laboratory outcomes of patients with Covid-19
Design
A randomized, three-sided, randomized controlled clinical trial on 129 patients was used using the randomized block method of Excel software.
Settings and conduct
The study population is all patients with Covid-19 hospitalized in the general wards of Shahid Labbafinejad Hospital in Tehran. The groups will evaluate the participants in terms of age, sex, and lung involvement with a standardized block block. The researcher will evaluate the study participants using a clinical outcome questionnaire and a laboratory findings questionnaire. Then he puts the medicine packages that he, the patient and the statistics consultant are unaware of in the participants' medicine box and asks the ward nurses to provide the medicine to the participants twice a day for 5 days.
Participants/Inclusion and exclusion criteria
Admission: All patients with Covid - 19 approved by the doctor - Age 18-70 years - Level of consciousness 15
Withdrawal: taking supplements containing oleopurine - any underlying disease - pregnancy and lactation - hypoglycemia - hypotension - unwillingness to cooperate - allergies - not taking the right medication
Intervention groups
Olive leaf extract group at a dose of 250 mg twice a day for five days
Olive leaf extract group at a dose of 500 mg twice a day for five days
control group Use of wheat placebo in capsules of the same shape with intervention groups twice a day for five days
Main outcome variables
Temperature, blood pressure, heart rate, percentage of arterial oxygen saturation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201128049520N1
Registration date:2021-02-22, 1399/12/04
Registration timing:prospective
Last update:2021-02-22, 1399/12/04
Update count:0
Registration date
2021-02-22, 1399/12/04
Registrant information
Name
Elham Ahmadpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 66 3341 3823
Email address
elhamahmadpour10@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-03-05, 1399/12/15
Expected recruitment end date
2021-06-22, 1400/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of alcoholic extract of the olive leaf on clinical and Laboratory outcomes of patients with Covid-19
Public title
effect of olive leaf extract on Covid-19 patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
All patients with Quid-19 based on standard diagnostic test (positive PCR test, CT scan of lung) approved by infectious disease specialist
Age range is 18 to 70 years
Have a level of consciousness of 15 according to the Glasgow standard
Exclusion criteria:
Take oleopurine supplements 3 months before the study
Use of mechanical ventilation equipment
Existence of underlying respiratory diseases such as COPD, asthma
Taking anti-hypertensive, anti-platelet and anti-diabetic drugs
Pregnancy and lactation
Immune system deficiency or the use of immunosuppressive drugs
Malignancies
Presence of heart, kidney, liver, blood pressure, diabetes and corticosteroid disorders
Reluctance to continue cooperation
The patient is discharged earlier than the completion of the treatment period
Hypotension (mean arterial pressure less than 70 mm Hg)
Hypoglycemia (blood sugar less than 75 mg / dL)
Existence of allergies to drugs before and during the study
Lack of proper use of drugs
The need for therapeutic interventions other than the usual therapeutic interventions during research such as the need for dialysis, angioplasty and ...
Participate in other research that in any way affects the results of the research
Age
From 18 years old to 70 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
129
Randomization (investigator's opinion)
Randomized
Randomization description
Allocation of samples in study groups by random blocking method
Blinding (investigator's opinion)
Triple blinded
Blinding description
Capsules containing olive leaf extract in two doses of 250 and 500 mg and placebo are exactly the same in terms of color, shape and size and are coded and packaged by another person without the knowledge of the researcher, analyst and participant The contents of the capsule will be placed in the participants' medicine boxes. Before the start of the study and when informed consent is obtained from the participant, they are informed that they are randomly placed in one of the intervention or control groups.
Before the start of the study and when informed consent is obtained from the participant, they are informed that they are randomly placed in one of the intervention or control groups.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Lorestan University of Medical Sciences
Street address
University of Medical Sciences, Shahid Anoushirvan Rezaei Square, Moallem St, Khorramabad
City
Khorramabad
Province
Lorestan
Postal code
6813833946
Approval date
2021-02-15, 1399/11/27
Ethics committee reference number
IR.LUMS.REC.1399.262
Health conditions studied
1
Description of health condition studied
COVID - 19
ICD-10 code
B34.2
ICD-10 code description
Coronavirus infection, unspecified
Primary outcomes
1
Description
Arterial oxygen saturation
Timepoint
Before starting the intervention, then for five days twice a day from 6 am to 6 pm
Method of measurement
Medair pulse oximeter device
2
Description
Heart rate
Timepoint
Before starting the intervention, then for five days twice a day from 6 am to 6 pm
Method of measurement
pulse oximeter device
3
Description
Temperatures
Timepoint
Before starting the intervention, then for five days twice a day from 6 am to 6 pm
Method of measurement
Digital thermometer
4
Description
blood pressure
Timepoint
Before starting the intervention, then for five days twice a day from 6 am to 6 pm
Method of measurement
Hand pressure gauge
5
Description
Complete blood count
Timepoint
Before and during the intervention on a daily basis
Method of measurement
Patient file
Secondary outcomes
1
Description
Severity of general symptoms of Covid-19 disease
Timepoint
Before and during the intervention on a daily basis
Method of measurement
Symptom Severity Questionnaire
2
Description
Duration of hospitalization
Timepoint
Patient discharge time
Method of measurement
Counting the number of days the patient is hospitalized
Intervention groups
1
Description
Intervention group: Patients who at the same time with standard treatments, capsules containing olive leaf extract (capsules with a dose of 250 mg twice a day for five days) olive leaf extract by Rose Daru Pharmaceutical Company in drug capsules of the same shape and size as other groups The intervention will be prepared and stored in conditions away from light and moisture.
Category
Treatment - Drugs
2
Description
Intervention group: Patients who at the same time with standard treatments, capsules containing olive leaf extract (capsules with a dose of 500 mg twice a day for five days) olive leaf extract by Rose Daru Pharmaceutical Company in drug capsules of the same shape and size as other groups The intervention will be prepared and stored in conditions away from light and moisture.
Category
Treatment - Drugs
3
Description
Control group: Patients who receive placebo at the same time as standard treatments in the form of capsules containing wheat flour twice a day for five days. The placebo will be stored by Rose Drug Pharmaceutical Company in drug capsules of the same shape and size as the other intervention groups prepared away from light and moisture.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Labbafinejad hospital
Full name of responsible person
Elham Ahmadpour
Street address
Shahid Labbafinejad hospital, 9th Bosthan Alley, Pasdaran St.
City
Tehran
Province
Tehran
Postal code
1666663111
Phone
+98 21 23601
Email
elhamahmadpour10@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Ebrahim Fallahi
Street address
University of Medical Sciences, Shahid Anoushirvan Rezaei Square, Moallem St, Khorramabad