Protocol summary
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Study aim
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Evaluation of the effect of green tea supplemention on inflammatory biomarkers and CBC in patients with Covid 19
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Design
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Clinical trial with control group, with parallel groups, double-blind, randomized, on 74 patients with Covid 19, Randomization will be allocate
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Settings and conduct
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This study will be performed in 74 patients with Covid-19 in Shahid Jalil Hospital in Yasuj. Patients are randomly divided into intervention and placebo groups and will receive 2 green tea capsule or placebo daily for 14 days. At the beginning and end of the study, the desired variable will be examined.
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Participants/Inclusion and exclusion criteria
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74 patients with Covid 19 based on definitive diagnosis of PCR, admitted to Shahid Beheshti Hospital in Yasuj will be included in the study based on admission and non-admission Inclusion criteria: (1) Written informed consent form, (2) Age 18 years old or above, (3) Definitive diagnosis of Covid 19, (4) Willingness to participate in research study Non-inclusion criteria: (1) Pregnancy or lactation, (2) Other contraindications prescribed by the specialist, (6) Participate in any clinical trial
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Intervention groups
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The intervention group will receive daily 2 green tea supplement and the placebo group will receive daily 2 placebo twice a day for 14 days.
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Main outcome variables
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Inflammatory biomarker include CRP, ESR and CBC
General information
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Reason for update
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Sampling was forced to be suspended due to lack of funding from the university
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20150711023153N3
Registration date:
2021-06-04, 1400/03/14
Registration timing:
prospective
Last update:
2021-10-26, 1400/08/04
Update count:
1
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Registration date
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2021-06-04, 1400/03/14
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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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2021-07-11, 1400/04/20
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Expected recruitment end date
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2021-12-21, 1400/09/30
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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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Evaluation the Effects of Green Tea Supplement on CBC & Inflammatory Biomarkers in Covid 19 Patients: Randomized Clinical Trial; Double blind
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Public title
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Evaluation the Effects of green tea supplement in Covid 19 patients
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Purpose
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Supportive
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Inclusion/Exclusion criteria
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Inclusion criteria:
18 years old or above
Written informed consent form
COVID-19 diagnosis based on polymerase chain reaction (PCR)
Willingness to participate in research study
Exclusion criteria:
Pregnancy or lactation
Disseminated intravascular coagulation or any other types of coagulopathy
Severe congestive heart failure by the specialist
Other contraindications prescribed by the specialist
Participation in any clinical trial within the past 30 days prior to enrollment in the present study
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Age
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From 18 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
- Investigator
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Sample size
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Target sample size:
74
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Patients will be stratify by Block Random sampling based on age and sex in one of 8 blocks of 9 and 10 people and by computer generated random numbers (Randomization.com) in one of two intervention or placebo groups, this list is in the hands of the group's secretary and Who Does not play a role in the study
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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Blinding of patients, health care professionals, principal investigators
as well as data collectors and data analysts will be unaware of the intervention and placebo groups still the end of the study. The intervention includes a placebo or green tea extract capsule in special package and exactly same in color and taste are labeled with different numbers, and the contents of these numbers will be kept in a closed envelope in the faculty and its contents will be preserved until the end of the study.
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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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2021-05-15, 1400/02/25
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Ethics committee reference number
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IR.YUMS.REC.1400.027
Health conditions studied
1
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Description of health condition studied
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covid19
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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 DISEASE
Primary outcomes
1
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Description
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CRP
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Timepoint
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Before the intervention and at the end of day 14 study
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Method of measurement
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Elisa Kit
2
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Description
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Erythrocyte Sedimentation Rate (ESR)
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Timepoint
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Before the intervention and at the end of day 14 study
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Method of measurement
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Elisa Kit
3
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Description
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CBC
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Timepoint
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Before the intervention and at the end of day 14 study
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Method of measurement
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Cell counter devices
Intervention groups
1
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Description
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Intervention group: Patients receiving 2green tea extract capsule that each one have 450 mlgr twice a day after lunch and after dinner + usual hospital medicine
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Category
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Treatment - Other
2
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Description
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Control group: Patients receiving 2 placebo capsule twice a day after lunch and after dinner + usual hospital medicine
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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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Yasouj 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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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be 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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Undecided - It is not yet known if there will be a plan to make this available
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Title and more details about the data/document
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All potential data can be shared after blinding
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When the data will become available and for how long
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Six months after publishing
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To whom data/document is available
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Researchers working in academic institutions
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Under which criteria data/document could be used
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For research purposes and meta-analysis studies
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From where data/document is obtainable
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Dr. Seyed bahman panahande . Faculty member of the Health and Nutrition, Yasuj University of Medical Sciences
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What processes are involved for a request to access data/document
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Official letter to the researchers
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Comments
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