Protocol summary
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Study aim
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Determination of the grapefruit seed extract efficacy in the treatment of COVID-19 as an adjuvant therapy
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Design
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Two arms, double-blind, parallel-group randomized pilot trial with 15 patients in each arm that assigned by coin's head or tail.
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Settings and conduct
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A pilot intervention study on 15 volunteer patients with COVID-19 at Masih Daneshvari Hospital in Tehran confirmed by PCR. Patients' information is considered confidential and they enter the study with informed consent and can leave the study at any time if they wish to do so. The intervention is the administration of grapefruit seed extract or placebo, which is administered orally to patients 10 drops three times a day for 7 days.
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Participants/Inclusion and exclusion criteria
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All infectious ward inpatients in Masih Daneshvari hospital above 18 and under 60 years old, that their COVID-19 is confirmed by PCR test, and don't have any cardiovascular, diabetes, renal, autoimmune, and allergy disease, and do not consume any cardiovascular drugs, anticoagulants, antidiabetes, anti hypercholesteremia, immunosuppressive and anti-allergy drugs, and are designated to take daily Kaletra
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Intervention groups
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Ten drops of grapefruit seed extract or placebo as adjuvant therapy are added to the COVID-19 pharmacotherapy regimen and its efficacy and adverse effects will be evaluated.
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Main outcome variables
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The findings of the study are oxygen saturation, disease symptoms, and medication side effects that are checked daily and the patient's paraclinic involves biochemical tests, lymphocyte count, ESR, CRP, which are tested at 7-day intervals.
General information
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Reason for update
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The person responsible for updating the information has been changed
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20140312016968N2
Registration date:
2020-11-01, 1399/08/11
Registration timing:
retrospective
Last update:
2020-12-07, 1399/09/17
Update count:
1
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Registration date
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2020-11-01, 1399/08/11
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2020-04-21, 1399/02/02
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Expected recruitment end date
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2020-06-21, 1399/04/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Pilot study of the Grapefruit seed extract adjuvant therapy on COVID-19
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Public title
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Study of the effects of grapefruit extract on COVID-19
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Ages between 18-60 years
Inpatients of the wards
Daily Lopinavir / Ritonavir
PCR confirmed COVID-19
Without background disease
Exclusion criteria:
Age above 60 and below 18
Cardiovascular disease
Diabetes
Autoimmune disease
Renal disease
Respiratory distress on admission time
Allergy history
Consumption of cardiovascular drugs, anti diabetes, anti coagulants, anti HIV, anti cholesterol, immunsuppressive, and cancer chemotherapy agents
Reluctance to participate in the study
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Age
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From 18 years old to 60 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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- Participant
- Care provider
- Outcome assessor
- Data and Safety Monitoring Board
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Sample size
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Target sample size:
20
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Patients with inclusion criteria are allocated to a medication or placebo category based on coin chance
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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Only the principal investigator knows the codes and all of the clinical staff are blinded. Containers containing the medicine/ placebo, their color and viscosity are the same, but their taste is different.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2020-04-06, 1399/01/18
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Ethics committee reference number
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IR.SBMU.RETECH.REC.1399.041
Health conditions studied
1
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Description of health condition studied
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COVID-19
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ICD-10 code
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U07.1
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ICD-10 code description
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COVID-19, virus identified
Primary outcomes
1
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Description
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O2 saturation
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Timepoint
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Measurement of oxygen saturation every day during the study
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Method of measurement
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Pulse oximetry device
2
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Description
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Adverse drug reaction
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Timepoint
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Daily recording of possible adverse effects of the extract
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Method of measurement
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Observational recording
Intervention groups
1
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Description
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Intervention group: For 7 days, three times a day, each time 10 drops of grapefruit seed extract in addition to routine medication that is Kaltra receive. The medicine should be poured in half a glass of water and consumed. The drug uses the GSE brand made by Nutribiotic Company, which is dissolved in oral glycerin, which has been poured and labeled to be hidden in plastic dropper containers.
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Category
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Treatment - Drugs
2
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Description
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Control group: For 7 days, three times a day, each time 10 drops of orange concentrate in addition to routine medication that is Kaltra receive. The medicine should be poured in half a glass of water and consumed. The placebo solution is Sunich orange extract, which is poured into the same plastic dropper containers and labeled the same as the medicine, only the code is different.
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Category
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Placebo
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Shahid Beheshti University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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Generalities are presented as a printed article. And detailed information is available to the researcher and is provided whenever requested.
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When the data will become available and for how long
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Since the publication of the article
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To whom data/document is available
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Researchers and regulatory organizations
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Under which criteria data/document could be used
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To review the results by regulatory agencies and researchers
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From where data/document is obtainable
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To the principal investigator and clinical associate
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What processes are involved for a request to access data/document
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By email to the principal investigator
aliziai@sbmu.ac.ir
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Comments
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