Efficacy and safety of polyherbal formulation as an add-on to standard-of-care in mild-to-moderate COVID-19: A randomized, double-blind, placebo-controlled trial

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Abstract

No abstract available

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  1. SciScore for 10.1101/2021.05.14.21256900: (What is this?)

    Please note, not all rigor criteria are appropriate for all manuscripts.

    Table 1: Rigor

    EthicsIRB: The study was approved by the Board of Research Studies (BORS) and Institutional Ethics Committee of Yashwantrao Chavan Memorial Hospital, Pimpri, Pune.
    Consent: Informed consent was obtained from all the participants before enrolment.
    Sex as a biological variablePregnant and lactating females, any respiratory symptoms of >7 days, patients with known pathology affecting the respiratory system, diagnosed hematological disorders, patients with a terminal illness, any other condition which in the view of the investigator would interfere with the general clinical well-being of the participant and those not willing to participate in the study were excluded.
    RandomizationDesign and Population: This study was a double-blind, randomized, placebo-controlled trial to assess the safety and efficacy of polyherbal drug formulation (designated as IP) in patients with mild to moderate COVID-19.
    Blindingnot detected.
    Power Analysisnot detected.

    Table 2: Resources

    Antibodies
    SentencesResources
    Also, change in immunological parameters such as lymphocyte subset analysis (TH1, TH2, Th17),NK Cells and CD markers, serum IgG and IgM levels and Covid19 antibodies were assessed.
    TH1
    suggested: None
    TH2
    suggested: None
    Covid19
    suggested: None

    Results from OddPub: We did not detect open data. We also did not detect open code. Researchers are encouraged to share open data when possible (see Nature blog).


    Results from LimitationRecognizer: We detected the following sentences addressing limitations in the study:
    Limitation of the study is smaller number of participants. Currently the formulation is known as Capsule CoviLyzer™ and Capsule Abayakasthaa plusR, and is manufactured by Ishaanav Nutraceuticals Pvt. Ltd.

    Results from TrialIdentifier: No clinical trial numbers were referenced.


    Results from Barzooka: We did not find any issues relating to the usage of bar graphs.


    Results from JetFighter: We did not find any issues relating to colormaps.


    Results from rtransparent:
    • Thank you for including a conflict of interest statement. Authors are encouraged to include this statement when submitting to a journal.
    • Thank you for including a funding statement. Authors are encouraged to include this statement when submitting to a journal.
    • No protocol registration statement was detected.

    Results from scite Reference Check: We found no unreliable references.


    About SciScore

    SciScore is an automated tool that is designed to assist expert reviewers by finding and presenting formulaic information scattered throughout a paper in a standard, easy to digest format. SciScore checks for the presence and correctness of RRIDs (research resource identifiers), and for rigor criteria such as sex and investigator blinding. For details on the theoretical underpinning of rigor criteria and the tools shown here, including references cited, please follow this link.