- Open Access
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
Trials volume 22, Article number: 246 (2021)
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).
This is a randomized, placebo-controlled, double-blind, parallel 2-arm (1:1 ratio) clinical trial.
Patients with COVID-19 admitted to hospitals in Yasuj City, Kohgiluyeh and Boyer-Ahmad Province, Iran.
Patients 18 years of age or older
Diagnosis of COVID-19 based on real-time polymerase chain reaction (RT-PCR) test
Pregnancy or lactation
Immunoglobulin A (IgA) level <61 mg/dl
Disseminated intravascular coagulation or any other types of coagulopathy
Severe congestive heart failure
Participation in any clinical trial within 30 days prior to enrollment in this RCT
Other contraindications determined by the specialist.
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)
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.
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.
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.
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.
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
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.
Availability of data and materials
The final dataset of the trial will be available upon request from the primary investigator via e-mail at firstname.lastname@example.org, after obtaining permission from the Regional Ethics Committee.
The authors would like to thank the Yasuj University of Medical Sciences for supporting the present research on COVID-19.
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.
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
The authors declare that they have no competing interests.
Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.
About this article
Cite this article
Yousefi, M., Sadriirani, M., PourMahmoudi, A. et al. 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. Trials 22, 246 (2021). https://doi.org/10.1186/s13063-021-05194-9
- Randomized Controlled Trial
- Pomegranate Juice