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

evaluation of the effects of Bromelain, Curcumin and Epigallocatechin in the treatment of outpatient Covid-19 infection.

300 Covid-19 positive patients over 18 year old referred to infectious disease clinic enter the case or control group. After adjusting for age, sex, underlying disease and chest CT scan, patients are divided randomly to receive the main or placebo agent in a double blind manner.

After obtaining informed consent and Explanation for patients referred to the Urmia Tadbir clinic divide into case or control groups. The intervention group will be prescribed 2 tablets (Bromelain, Curcumin and Epigallocatechin) daily for 5 days, 12 hours along with standard treatment as add on therapy. The placebo group will receive 2 placebo tablets daily for 5 days, 12 hours along with standard treatment as add on therapy. All patients will be followed every day or until the occurrence of hospitalization or death by phone call. Finally the duration and severity of symptoms and the frequency of adverse events will be compared between two groups.

Inclusion criteria: Patients with Covid-19 over 18 years Exclusion criteria: history of allergies to green tea, pineapple, latex, turmeric, gastric ulcer in the last 6 months, active bleeding, pregnancy, hepatic or renal failure, coagulation disease, autoimmune disease, gallstones, need of hospitalization

The intervention group will receive 2 capsules, each capsule containing Bromelain, Curcumin, Epigallocatechin daily for 5 days, 12 hours along with standard treatment. Control group will receive 2 placebo tablets for 5 days, 12 hours along with standard treatment.

Blood oxygen saturation, sense of smell, sense of taste, fever, lung involvement, cough, muscle pain, weakness, gastrointestinal symptoms, death, hospitalization

Record the end of the trial

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.

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.

All data is potentially shareable after unidentified patients

Access period start 1 month after publishing the results

University professors, clinical specialists, researchers, and journals

Official request from organization

Person responsible for scientific inquiries

Request to Vice-Chancellor for Research and Technology Affairs in Urmia university of medical science