Comparison of the effectiveness of cranberry fruit and placebo in the treatment of symptoms of Covid-19 patients
Design
Clinical trial with control group, with parallel groups, double-blind, randomized, phase 2 on 120 patients. Random Allocation software was used for randomization.
Settings and conduct
In this study, 120 patients with positive covid-19 PCR referred to Imam Reza Hospital in Tabriz were randomly admitted to one of the two groups which studied (two group of drug and placebo). 60 patients entered the intervention group and 60 patients entered the placebo group. Patients' information including age, gender, vital signs upon arrival, extent of pulmonary involvement were recorded by CT-Scan, underlying disease, and medications used. Patients in the intervention group received 500 g of Cranberry capsule daily. The control group received starch-containing capsules as a placebo. Patients were asked to take one capsule daily, then the patients were followed up by telephone for 14 days. Participants and researchers compared the type of blinded capsule and the capsule information in a sealed envelope until the end of the study. The effectiveness of the capsule in reducing clinical symptoms (cough, fatigue and other symptoms) and paraclinical findings as well as the possible side effects of the drug were measured.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Confirmation of Covid-19 by PCR; consent to participate in the study
Exclusion criteria: underlying disease; pregnancy; discontinuation of the drug
Intervention groups
60 patients received Cranberry capsule daily as an intervention group and 60 patients received a starch-containing capsule as a control group.
Main outcome variables
Clinical symptoms (cough, fever, etc.) Paraclinical variables (wbc, IL-6, TNF) of the group receiving cranberry and placebo in patients with Covid-19 before and after the intervention
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20101201005287N3
Registration date:2022-02-22, 1400/12/03
Registration timing:retrospective
Last update:2022-02-22, 1400/12/03
Update count:0
Registration date
2022-02-22, 1400/12/03
Registrant information
Name
Akbar Sharifi
Name of organization / entity
Tabriz Medical University
Country
Iran (Islamic Republic of)
Phone
+98 41 1337 5449
Email address
asharifi@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-12-09, 1400/09/18
Expected recruitment end date
2021-12-13, 1400/09/22
Actual recruitment start date
2021-12-09, 1400/09/18
Actual recruitment end date
2021-12-19, 1400/09/28
Trial completion date
empty
Scientific title
Comparison of the effectiveness of cranberry fruit and placebo in the treatment of symptoms of Covid-19 patients
Public title
Cranberry fruit in COVID-19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Confirmation of Covid-19 by PCR test
Satisfaction to participate in the study
Exclusion criteria:
Having an underlying disease
Pregnant patients
Stop taking the drug
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
120
Actual sample size reached:
120
Randomization (investigator's opinion)
Randomized
Randomization description
From the patients who volunteered to participate in the study, 120 people will be selected by simple random sampling. Randomization method: block
Randomization unit: individual
Random layers: In each block, people will be matched based on age and gender.
Random Allocation tool: Random Allocation software
How to build a random sequence: Using Random Allocation software
Concealment: A random sequence created in a safe place and performed by an independent, non-independent person during the study.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is a double-blind study that evaluates the consequences in this study and patients participating in the study will be unaware of the type of supplement received. Supplements will be provided to patients by another person who has no role in completing the questionnaire. Patients will also be informed of the existence of two types of supplements (cranberry fruit capsules and placebo) when obtaining consent, but will be unaware of which study groups they will be placed in. The capsules are exactly the same in shape, color and size and will smell the same due to their proximity for several days.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Emam Reza hospital, Golgasht Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Approval date
2021-12-09, 1400/09/18
Ethics committee reference number
IR.TBZMED.REC.1400.918
Health conditions studied
1
Description of health condition studied
COVID-19, virus identified
ICD-10 code
U07.1
ICD-10 code description
COVID-19, virus identified
Primary outcomes
1
Description
Interleukin-6 blood levels of patients before and after taking the drug
Timepoint
Before starting the drug and 14 days after taking the drug
Method of measurement
Blood sample analysis for IL-6 by ELISA in the laboratory
Secondary outcomes
1
Description
Serum TNF-α levels in patients' plasma
Timepoint
At the beginning of the study (before the intervention) and 14 days after starting the drug
Method of measurement
Blood sample analysis for TNF-α by ELISA in the laboratory
Intervention groups
1
Description
Intervention group: For 14 days, patients received the cranberry capsule (500 g) prepared in Tabriz School of Pharmacy, while receiving it from the researcher while visiting Imam Reza Hospital, and consumed one glass daily with a glass of water.
Category
Treatment - Drugs
2
Description
Control group: For 14 days, patients received a starch capsule (500 g) prepared in Tabriz School of Pharmacy, while visiting the Imam Reza Hospital from a researcher, consuming one daily with a glass of water.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza hospital
Full name of responsible person
Akbar Sharifi
Street address
Emam Reza hospital, Golgast street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3334 7059
Email
asharifi@tbzmed.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Akbar Sharifi
Street address
Vice chancellor for research, Tabriz Medical University, Daneshgah square
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3336 4659
Email
Asharifi@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Akbar Sharifi
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Bronchoscopy ward, Emam Reza hospital, Golgasht street
City
Tabriz
Province
East Azarbaijan
Postal code
1566614766
Phone
+98 41 1337 5449
Fax
+98 41 1337 5449
Email
asharifi@tbzmed.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Akbar Sharifi
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Bronchoscopy ward, Emam Reza hospital, Golgasht street
City
Tabriz
Province
East Azarbaijan
Postal code
1566614766
Phone
+98 41 1337 5449
Fax
+98 41 1337 5449
Email
asharifi@tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Akbar Sharifi
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Bronchoscopy ward, Emam Reza hospital, Golgasht street
City
Tabriz
Province
East Azarbaijan
Postal code
1566614766
Phone
+98 41 1337 5449
Fax
+98 41 1337 5449
Email
asharifi@tbzmed.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