Research Article
Effects of Pomegranate Juice (Punica Granatum) on Inflammatory Biomarkers and Complete Blood Count in Patients with COVID-19: A Structured Summary of a Study Protocol for a Randomized Clinical Trial
https://doi.org/10.21203/rs.3.rs-306280/v1
This work is licensed under a CC BY 4.0 License
published 02 Apr, 2021
You are reading this latest preprint version
Objectives
This study is conducted to investigate efficacy of pomegranate juice on inflammatory biomarkers, C-reactive protein (CRP), interleukin 6(IL-6), erythrocyte sedimentation rate (ESR) and complete blood count (CBC) in hospitalized patients with mild to moderate coronavirus disease 2019 (COVID- 19).
Trial Design
This is a randomized, placebo-controlled, double-blind, parallel 2-arm (1:1 ratio) clinical trial.
COVID-19
Randomized Controlled Trial
Protocol
Pomegranate Juice
CRP
IL-6
CBC
ESR
Patients with COVID-19 admitted to hospitals in Yasuj City, Kohgiluyeh and Boyer-Ahmad Province, Iran.
Inclusion Criteria
Exclusion Criteria
Intervention and Comparator
Intervention: 500 ml pomegranate juice and standard of care hospital treatment for COVID-19
Comparator: matching placebo containing 500 ml of red water and standard of care hospital treatment for COVID-19
Both intervention and comparator to be taken twice a day, after lunch and dinner, for 14 days.
Criteria for Discontinuing
Transfer of patients to intensive care unit (ICU)
Death
Unwillingness to continue participating in the study
The main outcomes of this study are levels of inflammatory biomarkers, CRP, IL-6, ESR, and CBC after 14 days of treatment.
Randomization
Eligible patients will be randomly assigned into the intervention or control group in a 1:1 ratio. Randomization will be performed based on 8 permuted blocks with block sizes of 6 and they will be stratified according to sex and age categories. Randomization sequences will be prepared by the trial’s pharmacist using computer-generated random numbers.
Blinding (Masking)
This study is a double-blind clinical trial (participant, researcher). The pomegranate juice and placebo juice are packaged in identical bottles, and the researcher and all the patients will be unaware of the study assignment until the end of the study. To ensure blinding, the randomization sequences will be kept in identical, opaque, sealed, and sequentially numbered envelopes.
Numbers to Be Randomized (Sample Size)
The calculated total sample size is 48 patients, with 24 patients assigned into each group.
Trial Status
The protocol is Version 1.0, on March 3, 2021. Recruitment started on February 28, 2021, and is anticipated to be completed by May 21, 2021.
Trial Registration
The Name of registering trial
Effects of Pomegranate Juice (Punica Granatum) on Inflammatory Biomarkers and CBC in Patients with COVID-19: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial.
Iranian registry of clinical trials (IRCT) Registration Number: IRCT20150711023153N2
Date of Trial Registration
February 28, 2021, retrospectively registered
Full Protocol
The full protocol is attached as an additional file, accessible from the Trials҆ website (Additional file 1). In the interest of expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.
Ethics Approval and Consent to Participate
The present trial was approved by the Ethics Committee of Yasuj University of Medical Sciences (Ethics Committee Reference Number: IR.YUMS.REC.1399.181) on January 20, 2021. The investigators declare that the trial has received ethical approval from the appropriate ethics committee, as described above. Informed written consent will be obtained from all the participants, prior to randomization.
Consent for Publication
Not applicable.
Availability of Data and Materials
The final dataset of the trial will be available upon request from the primary investigator via e-mail at [email protected], after obtaining permission from the Regional Ethics Committee.
Competing Interests
The authors declare that they have no competing interests.
Funding
This study was funded and supported by Yasuj University of Medical Sciences, Yasuj, Kohgiluyeh and Boyer-Ahmad Province, Iran. The funders did not have a role in the design of the study, the intervention, collection, analysis, interpretation of data and writing the manuscript.
Authors' Contributions
SBP is the Chief Investigator; he conceived the study. SBP and MY led the proposal and protocol development. MY, MRSI, BS, SM and ZS are contributing to data collection, study design and to development of the proposal. SBP and MY are revising the manuscript. MH and AP contributed to statistical interpretations. All authors read and approved the final manuscript.
Acknowledgements
The authors would like to thank the Yasuj University of Medical Sciences for supporting the present research on COVID-19.
published 02 Apr, 2021
Editorial decision: Accept
15 Mar, 2021
Reviewers invited by journal
14 Mar, 2021
Reviews received at journal
14 Mar, 2021
Editor invited by journal
14 Mar, 2021
First submitted to journal
06 Mar, 2021
You are reading this latest preprint version