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IRCT20180205038626N8 IRCT 2021-05-09 Rasht University of Medical Sciences Effects of green tea consumption on fatigue, depression and anxiety scores in COVID-19 patients 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 2021-04-21 anticipated 84 Complete https://irct.ir/trial/55208 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, 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. 2 Coronavirus disease. Intervention 1: 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. Intervention 2: 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. Yes - There is a plan to make this available What will be shared: Information on the main outcome When: Access period starts 6 months after the results are published To whom: Researchers working in academic institutions Conditions: Request to receive unidentifiable personal data or other documents Where to obtain: Marjan Mahdavi Roshan How to obtain: By email to Dr.Marjan Mahdavi Roshan Comments:
public Zahra Ahmadnia
Dr. Heshmat Hospital; Bayani St; Mosala Square; Rasht.
Rasht Iran (Islamic Republic of) 4193955588 +98 13 3361 8177 zahmadnia@gums.ac.ir Rasht University of Medical Sciences scientific Marjan Mahdavi Roshan
Dr. Heshmat Hospital; Bayani St; Mosala Square; Rasht.
Rasht Iran (Islamic Republic of) 4193955588 +98 13 3361 8177 Marjanmahdavi60@gmail.com Rasht University of Medical Sciences Iran (Islamic Republic of) 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 20 years 70 years Both 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 U07.1 COVID-19, virus identified Treatment - Other Placebo 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. 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. 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. Complete blood cell count and diffrential count. Timepoint: At the beginning of the study and one month later. Method of measurement: Cell counter devices. C-reactive protein. Timepoint: At the beginning of the study and one month later. Method of measurement: ELISA device. Lactate dehydrogenase. Timepoint: At the beginning of the study and one month later. Method of measurement: Biochemical autoanalyzer. Creatinine phosphokinase. Timepoint: At the beginning of the study and one month later. Method of measurement: Biochemical autoanalyzer. Troponin. Timepoint: At the beginning of the study and one month later. Method of measurement: ELISA device. D-dimer. Timepoint: At the beginning of the study and one month later. Method of measurement: ELISA device. Ferritin. Timepoint: At the beginning of the study and one month later. Method of measurement: ELISA device. 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. 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. Scale of anxiety based on State-Trait Anxiety Inventory (STAI) Questionnaire. Timepoint: At the beginning of the study and one month later. Method of measurement: State-Trait Anxiety Inventory (STAI) Questionnaire. Heshmat Tea Factory Rasht University of Medical Sciences Heshmat Tea Factory Approved 2021-03-10 Ethics committee of Guilan University of Medical Sciences Technology & Research Vice-chancellor of University; Shahid Siadati St; Namjoo St., Rasht Rasht Guilan Iran (Islamic Republic of)