]>
IRCT20111119008129N13 IRCT 2022-10-11 Boushehr University of Medical Sciences Evaluation of the effects of resveratrol in patients with Covid ۱۹ Evaluation of the effects of resveratrol consumption on inflammatory and biochemical parameters of patients with Covid ۱۹ 2022-10-17 anticipated 140 Complete https://irct.ir/trial/64750 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: The random allocation method in this study will be permutated block randomization, where T represents the person receiving the intervention and C represents the person who receive the Placebo. This method is performed by considering blocks of sizes 4 patients so that the total number of 4 permutations is equal to 6 blocks as follows: (C,C,T,T), (T,T,C,C), (C,T,T,C), (C,T,C,T), (T,C,C,T), (T,C,T,C), (C,T,C,T) Then, a number of 35 blocks will be randomly selected with replacement from these 6 blocks. Finally, the desired list of 35 blocks of 4 (4 * 35 = 140 total number of samples) is generated and the order of assignment to each of the samples participating in the study is determined. These steps are performed using R software version 3.6.3, Blinding description: First, all resveratrol and placebo capsules are prepared in the same shape and size and in packs of 20 for distribution to patients. The resveratrol and placebo packages are then labeled based on computer-generated codes (without indication of its content). Each of these codes is determined based on the sequence of random allocation of individuals to groups. The project manager, the only person who is aware of the codes and the order in which individuals are assigned to groups, is not involved in any of the evaluation and measurement of outcomes steps. On the other hand, the shape, size, and type of packaging of the resveratrol and placebo are exactly the same, so the patient and the outcome evaluator will not know the type of intervention. 3 Covid-19. Intervention 1: Intervention group: The patients will take resveratrol capsules(99% pure, Biotivia, Bioceuticals International SrI, and Italy، 250 mg, 3 times /day, in the morning, afternoon, and at night for a period of 7 days. Intervention 2: Control group: The patients will take neutral micro-cellulose capsules, Biotivia, Bioceuticals International SrI, and Italy، 250 mg, 3 times /day, in the morning, afternoon, and at night for a period of 7 days. Yes - There is a plan to make this available What will be shared: The Deputy of Research is responsible to provide the information and documents to the participants in the Trial When: After the trial was over and the results were analyzed, for a period of one year, access to the document is possible To whom: The data and other documents of the study will be given to my colleagues at my University and other researchers and academic members from different universities worldwide. Conditions: If the researcher wants the document to use in the following research. The patients who want to know about the results of the examination Where to obtain: The main investigator responsible for the trial, or the deputy of Research should be contacted How to obtain: The applicants should submit a request letter to the principal investigator, or a request from the deputy of research. Then, the request will be assessed by these authorities and the right files and documents will be submitted to the requester for a period of one or two weeks. Comments:
public Ali Movahed
Moallem ST, Bushehr University of Medical Sciences
Bushehr Iran (Islamic Republic of) 987514633341 +9877333240 amovahed58@gmail.com Boushehr University of Medical Sciences scientific Ali Movahed
Moallem ST, Bushehr University of Medical Sciences,
Bushehr Iran (Islamic Republic of) 987514633341 +98 77 3332 4044 amovahed58@gmail.com Boushehr University of Medical Sciences Iran (Islamic Republic of) Female and Male with the age between 18 to 55 years Long involvement approved by city scan Admitted to the hospital with Fever( ≥ 38 C°) The breath rate ≥ 24/min, or coughing ( before the 8th day of the disease ) Infection with covid 19, approved by PCR 18 years 55 years Both Pregnant women Patients with kidney Disease, Patients with hypercalcemia and hypercalciuria Patients with any type of allergic diseases Having any kind of disease by which the patients can't have a proper participation Inability to behave properly( having Mental problem Auto immune diseases ( having MS, Lupus ...) Kidney Failure, Hepatitis B and C Patients with acute covid 19 symptoms U07 COVID-19, virus identified Prevention Placebo Intervention group: The patients will take resveratrol capsules(99% pure, Biotivia, Bioceuticals International SrI, and Italy، 250 mg, 3 times /day, in the morning, afternoon, and at night for a period of 7 days. Control group: The patients will take neutral micro-cellulose capsules, Biotivia, Bioceuticals International SrI, and Italy، 250 mg, 3 times /day, in the morning, afternoon, and at night for a period of 7 days. Pulmonary involvement. Timepoint: The time of measurement will be after interventions for a period of 10 days, for all the participants in both groups. Method of measurement: Results of CT scan (chest radiography). CBC Test. Timepoint: The time of measurement will be after interventions for a period of 10 days, for all the participants in both groups. Method of measurement: By blood Auto-analyzer. Erythrocyte sedimentation rate (ESR). Timepoint: The time of measurement will be after interventions for a period of 10 days, for all the participants in both groups. Method of measurement: By ESR Reader. CRP. Timepoint: The time of measurement will be after interventions for a period of 10 days, for all the participants in both groups. Method of measurement: By biochemistry auto analyzer- spectrophotometer. Interleukin-1. Timepoint: The time of measurement will be after interventions for a period of 10 days, for all the participants in both groups. Method of measurement: By ELISA. Interleukin-6. Timepoint: The time of measurement will be after interventions for a period of 10 days, for all the participants in both groups. Method of measurement: By ELISA. TNFα. Timepoint: The time of measurement will be after interventions for a period of 10 days, for all the participants in both groups. Method of measurement: By ELISA. Alanine amino transferase. Timepoint: The time of measurement will be after interventions for a period of 10 days, for all the participants in both groups. Method of measurement: By biochemistry auto analyzer- spectrophotometer. Aspartate Aminotransferase (AST). Timepoint: The time of measurement will be after interventions for a period of 10 days, for all the participants in both groups. Method of measurement: By biochemistry auto analyzer- spectrophotometer. Alkaline Phosphatase (ALP). Timepoint: The time of measurement will be after interventions for a period of 10 days, for all the participants in both groups. Method of measurement: By biochemistry auto analyzer- spectrophotometer. FBS. Timepoint: The time of measurement will be after interventions for a period of 10 days, for all the participants in both groups. Method of measurement: By biochemistry auto analyzer- spectrophotometer. BMI. Timepoint: The time of measurement will be after interventions for a period of 10 days, for all the participants in both groups. Method of measurement: Scales and meters. BUN. Timepoint: The time of measurement will be after interventions for a period of 10 days, for all the participants in both groups. Method of measurement: By biochemistry auto analyzer- spectrophotometer. Creatinine. Timepoint: The time of measurement will be after interventions for a period of 10 days, for all the participants in both groups. Method of measurement: By biochemistry auto analyzer- spectrophotometer. Boushehr University of Medical Sciences Approved 2021-11-14 ٍEthics committee of Bushehr University of Medical Sciences,Office of deputy adviser for research Pardis Site, Next to Salmon Farsi Hospital, Department of Research,Bushehr University of Medical Science Bushehr Bushehr Iran, Islamic Republic Of 751473537 Bushehr Boushehr Iran (Islamic Republic of)