Evaluation of the effectiveness of sweet almond, oral product in improving Respiratory symptoms of patients with Quaid 19
Design
This study is a Controlled Clinical Trial that is performed on 60 patients with COVID19, with respiratory symptoms. Patients were divided into two random groups using a table of random numbers and and a code assigned to them. The intervention group receive sweet almond oral product and the prescribed drugs according to protocol and for the control group, given only prescription drugs according to protocol.
Settings and conduct
Patients who have been hospitalized with coronavirus diagnosis, at Masih Daneshvari Hospital in Tehran and have any respiratory symptoms receive 10 cc of oral almonds sweet product after each meal for 6 days. by.
The severity of dyspnea, cough and sleep quality,is evaluated with, questionnaire Dyspnoea, Leicester Cough questionnaire and
The Petersburg Questionnaire and recorded.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
All patients with corona (confirmed by test or CT) two years and older of both sexes who have one of the clinical manifestations (shortness of breath and cough).
Exclusion criteria:
Any allergies to Almonds sweet or other foods
Diabetic patients Taking
Hospitalization in the intensive care unit
Intervention groups
Patients with COVID19, who have any respiratory symptoms, receive oral product of sweet almond and prescription drugs, and the control group is given only prescription drugs.
Main outcome variables
almond sweet
shortness of breath
cough Intensity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180712040446N2
Registration date:2020-07-01, 1399/04/11
Registration timing:registered_while_recruiting
Last update:2020-07-01, 1399/04/11
Update count:0
Registration date
2020-07-01, 1399/04/11
Registrant information
Name
Atefe Sharif
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2247 3630
Email address
atf.sharif@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-30, 1399/04/10
Expected recruitment end date
2020-08-31, 1399/06/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of sweet almond ,Oral product, as a supplement in patients with COVID 19
Public title
Investigating the effect of sweet almond on symptoms of COVID 19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients with corona (confirmed by test or CT) who have one of the clinical manifestations (shortness of breath and cough).
Patients hospitalized
Exclusion criteria:
Any allergies to Almonds sweet or other foods
Patients who ate Almonds sweet regularly
Inability to take medication orally
Diabetic patients
Taking Opioid medications
Use of Antitussive products
Suffering from other respiratory diseases
Hospitalization in the intensive care unit
Age
From 2 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Random number table: Patients using random number tables and assigned according to code given to them, they are divided into two random groups.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences(SBUMS)
Street address
Shahid Beheshti University of Medical Sciences, Arabi Ave, Daneshjoo Blvd, Velenjak, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
19839-63113
Approval date
2020-04-08, 1399/01/20
Ethics committee reference number
IR.SBMU.NRITLD.REC.1399.120
Health conditions studied
1
Description of health condition studied
COVID-19
ICD-10 code
U07.1
ICD-10 code description
COVID-19
2
Description of health condition studied
Cough
ICD-10 code
R05
ICD-10 code description
Cough
3
Description of health condition studied
Shortness of breath
ICD-10 code
R06.02
ICD-10 code description
Shortness of breath
4
Description of health condition studied
Fever
ICD-10 code
R50.9
ICD-10 code description
Fever, unspecified
Primary outcomes
1
Description
Severity shortness of breath
Timepoint
At the beginning of the study, 3 and 6 days after the start using product
Method of measurement
Dyspnoea-12 questionnaire
2
Description
Severity of cough
Timepoint
At the beginning of the study, 3 and 6 days after the start using product
Method of measurement
Leicester Cough Questionnaire
Secondary outcomes
1
Description
Sleep Quality
Timepoint
At the beginning of the study, 3 and 6 days after the start of product consumption
Method of measurement
Petersburg Sleep Quality Questionnaire
Intervention groups
1
Description
Intervention group: Sweet almond product, 10 cc, three times a day, for 6 days, after each meal
Category
Treatment - Drugs
2
Description
Control group: Standard treatment for COVID-19, according to the protocol of the Ministry of Health, including hydroxychloroquine sulfate (Amin Isfahan Pharmaceutical Company) in a dose of 200 mg, twice a day for 14 days