Evaluation of the effects of green tea consumption compared with black tea on the severity of symptoms, some serum marker, and fatigue, depression and anxiety scores in COVID-19 patients
Determination of the effects of green tea consumption compared to black tea on the severity of symptoms, some serum marker and fatigue, depression and anxiety scores in outpatients with COVID-19
Design
Clinical trial with control group, with parallel groups, no blinding, randomized, phase 2 on 84 patients. Random permutation block method will be used to allocate consumption to the subjects. The website http://www.randomization.com will also be used for randomization.
Settings and conduct
A total of 84 patients with COVID-19 virus confirmed by PCR test referred to a private office or clinic of an infectious disease specialist will be included in the study. Patients in two groups of 42 will be treated with green tea as a drink (3 glasses per day) or black tea (3 glasses per day as a control group).
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Patients with COVID-19; Twice positive PCR test;Age over 20 years; Provide written consent to enter the study; Not participating in other clinical trials; no use of other types of herbal teas.
Exclusion criteria
Pregnancy or breastfeeding; Obesity(body mass index more than30 kg per square meter ) History of heart attack or stroke; history of coronary bypass graft or coronary angioplasty, hospitalization history with heart failure; Underlying diseases including chronic hepatitis, cirrhosis and cholestatic liver disease and severe renal failure; Chronic obstructive pulmonary disease or severe pneumonia ;Active gastrointestinal ulcers.
Intervention groups
Intervention group: Patients with covid 19 will consume three cups of green tea daily for four weeks from Heshmat Fooman tea factory .
Control group: Patients with covid 19 will consume three cups of black tea daily for four weeks from Heshmat Fooman tea factory .
Main outcome variables
The severity of symptoms؛ some serum marker؛ fatigue, depression, and anxiety scores
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180205038626N8
Registration date:2021-05-09, 1400/02/19
Registration timing:registered_while_recruiting
Last update:2021-05-09, 1400/02/19
Update count:0
Registration date
2021-05-09, 1400/02/19
Registrant information
Name
Zahra Ahmadnia
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 13 3361 8177
Email address
zahmadnia@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-21, 1400/02/01
Expected recruitment end date
2021-07-23, 1400/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effects of green tea consumption compared with black tea on the severity of symptoms, some serum marker, and fatigue, depression and anxiety scores in COVID-19 patients
Public title
Effects of green tea consumption on fatigue, depression and anxiety scores in COVID-19 patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
patients with COVID-19
Twice positive PCR test
Age over 20 years
Provide written consent to enter the study
Not participating in other clinical trials
no use of other types of herbal teas
Exclusion criteria:
Pregnancy or breastfeeding
Obesity(body mass index more than30 kg per square meter )
History of heart attack or stroke, history of coronary bypass graft or coronary angioplasty, hospitalization history with heart failure
Underlying diseases including chronic hepatitis, cirrhosis and cholestatic liver disease and severe renal failure
Chronic obstructive pulmonary disease or severe pneumonia
Active gastrointestinal ulcers
Age
From 20 years old to 70 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
84
Randomization (investigator's opinion)
Randomized
Randomization description
Randomized permutation block method will be used for allocating consumption of black or green tea to the subjects of the study, and considering quadruple blocks, 21 blocks will be produced for 84 patients. The website http://www.randomization.com will also be utilized for randomization. Moreover, in order to conceal the random allocation procedure, encrypted envelopes with random sequence will be used. Each subject’s envelope will be opened after approving the person`s eligibility for entering the study and Therefore, group A are the patients who receive green tea and group B are the patients that receive black tea.
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 Guilan University of Medical Sciences
Street address
Technology & Research Vice-chancellor of University; Shahid Siadati St; Namjoo St., Rasht
City
Rasht
Province
Guilan
Postal code
41446-66949
Approval date
2021-03-10, 1399/12/20
Ethics committee reference number
IR.GUMS.REC.1399.670
Health conditions studied
1
Description of health condition studied
Coronavirus disease
ICD-10 code
U07.1
ICD-10 code description
COVID-19, virus identified
Primary outcomes
1
Description
Severity of the viral infection clinical symptoms
Timepoint
At the beginning of the study and 7, 14 and 21 days after tea consumption
Method of measurement
The severity of clinical signs of viral infection will be detected through a respiratory rate more than 24 or a heart rate greater than 125 or the patient requires mechanical ventilation or saturation of peripheral oxygen less than 94% and also based on the patient's laboratory results including D- dimer more than 1000; creatinine phosphokinase twice the normal amount; positive troponin; progressive lymphopenia; ferritin more than 300.
2
Description
Complete blood cell count and diffrential count
Timepoint
At the beginning of the study and one month later
Method of measurement
Cell counter devices
3
Description
C-reactive protein
Timepoint
At the beginning of the study and one month later
Method of measurement
ELISA device
4
Description
Lactate dehydrogenase
Timepoint
At the beginning of the study and one month later
Method of measurement
Biochemical autoanalyzer
5
Description
Creatinine phosphokinase
Timepoint
At the beginning of the study and one month later
Method of measurement
Biochemical autoanalyzer
6
Description
Troponin
Timepoint
At the beginning of the study and one month later
Method of measurement
ELISA device
7
Description
D-dimer
Timepoint
At the beginning of the study and one month later
Method of measurement
ELISA device
8
Description
Ferritin
Timepoint
At the beginning of the study and one month later
Method of measurement
ELISA device
Secondary outcomes
1
Description
Depression score based on Patients Health Questionnaire-9
Timepoint
At the beginning of the study and one month later
Method of measurement
Patients Health Questionnaire-9
2
Description
Scale of fatigue based on Chalder Fatigue Scale (CFQ-11)
Timepoint
At the beginning of the study and one month later
Method of measurement
Chalder Fatigue Scale (CFQ-11) Questionnaire
3
Description
Scale of anxiety based on State-Trait Anxiety Inventory (STAI) Questionnaire
Intervention group: Patients with Covid 19 will be consumed daily with three cups of green tea equivalent to 12 grams of green tea per day from Heshmat Fooman tea factory for four weeks.
Category
Treatment - Other
2
Description
Control group: Patients with Covid 19 will be consumed daily with three cups of black tea equivalent to 12 grams of black tea per day from Heshmat Fooman tea factory for four weeks.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Razi hospital
Full name of responsible person
Marjan Mahdavi Roshan
Street address
Razi Educational and Medical Center, Sardar Jangal St.
City
Rasht
Province
Guilan
Postal code
4144895655
Phone
+98 13 3355 0028
Email
razi.hospital@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Mohammadreza Naghipour
Street address
Technology & Research Vice-chancellor of University; Shahid Siadati St; Namjoo St., Rasht
City
Rasht
Province
Guilan
Postal code
41446-66949
Phone
+98 13 3333 5821
Email
naghi@gums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rasht University of Medical Sciences
Proportion provided by this source
80
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
2
Sponsor
Name of organization / entity
Heshmat Tea Factory
Full name of responsible person
Abbas Mohebkhah
Street address
Heshmat tea Factory; km 6 of Qaleh Rudkhan road; Foman
City
Foman
Province
Guilan
Postal code
4358115371
Phone
+98 13 3471 4257
Email
heshmattea@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Heshmat Tea Factory
Proportion provided by this source
20
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Industry
Person responsible for general inquiries
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Zahra Ahmadnia
Position
Nurse
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Dr. Heshmat Hospital; Bayani St; Mosala Square; Rasht.
City
Rasht
Province
Guilan
Postal code
4193955588
Phone
+98 13 3361 8177
Fax
Email
zahmadnia@gums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Marjan Mahdavi Roshan
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Dr. Heshmat Hospital; Bayani St; Mosala Square; Rasht.
City
Rasht
Province
Guilan
Postal code
4193955588
Phone
+98 13 3361 8177
Email
Marjanmahdavi60@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Zahra Ahmadnia
Position
Nurse
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Dr. Heshmat Hospital; Bayani St; Mosala Square; Rasht.
City
Rasht
Province
Guilan
Postal code
4193955588
Phone
+98 13 3361 8177
Fax
Email
gums.icrc@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is 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
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Information on the main outcome
When the data will become available and for how long
Access period starts 6 months after the results are published
To whom data/document is available
Researchers working in academic institutions
Under which criteria data/document could be used
Request to receive unidentifiable personal data or other documents
From where data/document is obtainable
Marjan Mahdavi Roshan
What processes are involved for a request to access data/document