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IRCT20210724051971N1 IRCT 2021-08-16 Oroumia University of Medical Sciences Effect of Bromelain , Curcumin and Epigallocatechin in the treatment of outpatient Covid-19 patients A Randomized, Double-blind, Placebo-controlled study to Evaluate the Efficacy and Safety of the Bromelain, Curcumin and Epigallocatechin in the treatment of outpatient Covid-19 patients 2021-08-18 anticipated 300 Complete https://irct.ir/trial/57699 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization of patients will be done by the researcher using Excel software. Randomization will be done by creating blocks. The blocks will be considered in sizes of 4 people. Drugs and placebo are packed in similar envelopes and receive a unique 4-digit code. Then for each block there is a box containing 2 packs of drug and 2 packs of placebo (the packs have a code and the researchers do not know the type of drug) is considered that the packages are randomly distributed among the patients of each block, Blinding description: Patients, physicians and researchers who provide the drug are unaware of its contents because of the same packaging, appearance, taste, color, and instructions on the drugs, but the code on the drug will be different. The codes on the medicine are random. The codes and the type of drug is on a sheet that is sealed in the envelope and the envelope will be opened after the research is completed. The patient data collector and the statistical partner of the project also do not know the type of intervention. Due to the fact that in the control group, placebo is used, which is similar in appearance, taste, color and label to the intervened drug, therefore, patients will be unaware of the type of drug received. 3 Covid 19. Intervention 1: Intervention group: The group receiving 2 drug capsules In addition to standard treatments ( each capsule containing 150 mg Bromelain, 300 mg Curcumin and 50 mg Epigallocatechin ) daily at intervals of 12 hours during the day for 5 days. Intervention 2: Control group: The group receiving the 2 placebo capsules in addition to standard treatments daily at intervals of 12 hours during the day for 5 days. Yes - There is a plan to make this available What will be shared: All data is potentially shareable after unidentified patients When: Access period start 1 month after publishing the results To whom: University professors, clinical specialists, researchers, and journals Conditions: Official request from organization Where to obtain: Person responsible for scientific inquiries How to obtain: Request to Vice-Chancellor for Research and Technology Affairs in Urmia university of medical science Comments:
public Mahsa Behnemoon
No. 17, 2nd alley, Soltani Ave., Varzesh street, Urmia,Iran
Urmia Iran (Islamic Republic of) 5719633731 +98 44 3343 4393 behnemoon.m@umsu.ac.ir Oroumia University of Medical Sciences scientific Aliasghar Tabatabaei Mohammadi
Orjhans Street, Resalat Blvd, Urmia
Urmia Iran (Islamic Republic of) 5714783734 +98 44 3367 3397 Dr.alitabatabaei98@gmail.com Oroumia University of Medical Sciences Iran (Islamic Republic of) New 2019 Corona-virus infection (COVID-19) confirmed by rt-PCR test referred to an outpatient clinic Aged over 18 years 18 years no limit Both severe infection needing hospitalization according to the diagnosis of infectious disease specialist History of allergies to green tea, pineapple, latex and turmeric history of peptic ulcer in the last 6 months active bleeding (except for menstrual period ) hepatic or renal failure coagulopathies autoimmune disease pregnancy cholelithiasis administration of anti platelet or anticoagulant agents (except aspirin) J12.81 Pneumonia due to SARS-associated coronavirus Treatment - Drugs Placebo Intervention group: The group receiving 2 drug capsules In addition to standard treatments ( each capsule containing 150 mg Bromelain, 300 mg Curcumin and 50 mg Epigallocatechin ) daily at intervals of 12 hours during the day for 5 days Control group: The group receiving the 2 placebo capsules in addition to standard treatments daily at intervals of 12 hours during the day for 5 days Oxygen saturation. Timepoint: Up to two weeks after intervention. Method of measurement: Pulse oximetery. Body temperature. Timepoint: Up to two weeks after intervention. Method of measurement: Thermometer. Cough severity. Timepoint: Up to two weeks after intervention. Method of measurement: Clinical manifestations of the patient with a score of 1 to 10 depending on the cough severity. Myalgia. Timepoint: Up to two weeks after intervention. Method of measurement: Phone call, or visit by person in cases of symptom aggravation. Gastrointestinal symptoms. Timepoint: Up to two weeks after intervention. Method of measurement: Phone call, or visit by person in cases of symptom aggravation. Fatigue. Timepoint: Up to two weeks after intervention. Method of measurement: Phone call, or visit by person in cases of symptom aggravation. Sense of smell. Timepoint: Up to two weeks after intervention. Method of measurement: Phone call, or visit by person in cases of symptom aggravation. Sense of taste. Timepoint: Up to two weeks after intervention. Method of measurement: Phone call, or visit by person in cases of symptom aggravation. Mortality. Timepoint: Up to one month after intervention. Method of measurement: Phone call, and clinical follow up. Hospitalization. Timepoint: Up to one month after intervention. Method of measurement: Phone call, and clinical follow up. Lung involvement. Timepoint: Up to two weeks after intervention. Method of measurement: Phone call, and clinical follow up. Oroumia University of Medical Sciences Approved 2021-05-26 Research Ethics Committees of Urmia University of Medical Sciences Resalat st, Orjans Al, urmia university of medical sciences Urmia West Azarbaijan Iran (Islamic Republic of)