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IRCT20200504047298N2 IRCT 2020-06-15 Karaj University of Medical Sciences Effect of Opuntia Cactus extract in patients with Covid-19 Effect of Opontia Cactus extract on improving pulmonary and clinical function in patients with Covid-19 2020-07-10 anticipated 48 Complete https://irct.ir/trial/47675 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Other, Purpose: Supportive, Randomization description: In the current study, patients were randomly allocated into two groups of intervention and conventional treatment by balanced block randomization technique with 4 blocks.R software generated random numbers chains 1 to 6 until the desired sample size was achieved. Preparation of sequences of random allocation of cases and putting them in sealed envelopes (airtight) and numbered with a five-digit serial number were performed by a third person who was not involved in the study design, Blinding description: The treatment group is given a glass of cactus opuntia syrup and the control group is replaced by a syrup of apple extract in a simmilar colour and same glass. Whoever is given cactus syrup and who is given placebo syrup is considered to be blind for the patient and the researcher. So the patients and the researcher are in no way aware of the division of the control and medication group and receive their treatment and care process according to the country's guideline treatment. 3 Covid-19. Intervention 1: Intervention group: Cactus Opuntia is purchased from a reputable greenhouse in the form of cactus leaves and is extracted by the extraction machine in 250 cc bottles and is brought to the hospital daily for patients. In addition to standard treatment based on national guidelines, cactus extract 250 cc daily is given daily in the morning for 7 days and the patient is followed up for the next 7 days. Intervention 2: Control group: Control group: In this group, in addition to standard treatment based on national guidelines, 250 cc of aloe vera syrup is given daily. Yes - There is a plan to make this available What will be shared: Patient data will be published in average numbers not as a distinct ones. When: Access starts 6 months after printing results To whom: The data will be available to researchers working at academic and scientific institutions and industries Conditions: No other conditions are allowed for the use of data and documentation Where to obtain: z.siami@abzums.ac.ir How to obtain: The data will be sent via email no later than one month after the request. Comments:
public Zeinab Siami
Emam Ali hospital, Azimieh, Karaj
Karaj Iran (Islamic Republic of) 3154686695 +98 26 3252 7576 z.siami@abzums.ac.ir Karaj University of Medical Sciences scientific Zeinab Siami
Emam Ali hospital, Azimieh, Karaj
Karaj Iran (Islamic Republic of) 3154686695 +98 26 3252 7576 z.siami@abzums.ac.ir Karaj University of Medical Sciences Iran (Islamic Republic of) Patients who have CT scan or PCR data in accordance with Covid-19 Patients aged 18 to 60 years Patients who have not hypoxemia (oxygen saturation more than 90%) 18 years 60 years Both Patients who taking herbal supplements are excluded Patients who were receiving mechanical ventilation or extracorporeal membrane oxygenation (ECMO) ، are excluded Patients with signs of multiorgan failure at screening (Exclusion criteria included alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels greater than 5 times the upper limit of the normal range or estimated creatinine clearance of less than 50 ml per minute (by the Cockcroft–Gault formula)) are excluded Treatment - Other Placebo Intervention group: Cactus Opuntia is purchased from a reputable greenhouse in the form of cactus leaves and is extracted by the extraction machine in 250 cc bottles and is brought to the hospital daily for patients. In addition to standard treatment based on national guidelines, cactus extract 250 cc daily is given daily in the morning for 7 days and the patient is followed up for the next 7 days. Control group: Control group: In this group, in addition to standard treatment based on national guidelines, 250 cc of aloe vera syrup is given daily. Improving lung function. Timepoint: Before starting the intervention, Up to 14 days daily after starting the intervention. Method of measurement: Measurement of venous blood Oxygen. Improving clinical performance. Timepoint: Before starting the intervention, Up to 14 days after starting the intervention. Method of measurement: Clinical symptoms include cough, shortness of breath, body aches, headaches, weakness, and body temperature are examined daily. Karaj University of Medical Sciences Approved 2020-05-01 Ethics committee of Alborz University of Medical Sciences Emam Ali Hospital, Azimeyeh, Karaj Karaj Alborz Iran (Islamic Republic of)