The herbal combination of Sugarcane, Black Myrobalan, and mastic as a supplementary treatment for COVID-19: a randomized clinical trial

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   ScreenIT

   Apr 30, 2021

   SciScore for 10.1101/2021.04.27.21256221: (What is this?)

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

   Table 1: Rigor

   Ethics

   Consent: Study design: The present study is a double-blind, randomized clinical trial that was conducted over three months from April 2020 to June 2020 in patients admitted with a diagnosis of COVID-19 in Peymaniyeh Hospital in Jahrom, Iran. Ethical considerations: Before entering the patients in this study, the research process was explained and informed consent was obtained from them. IRB: This study was approved by the ethics committee of Jahrom University of Medical Sciences under the ethical code IR.JUMS.REC.1399.003 and was registered in the Iranian registry of clinical trials under the number IRCT20200415047082N1.

   Sex as a biological variable

   Inclusion criteria: Patients admitted with …

   SciScore for 10.1101/2021.04.27.21256221: (What is this?)

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

   Table 1: Rigor

   Ethics	Consent: Study design: The present study is a double-blind, randomized clinical trial that was conducted over three months from April 2020 to June 2020 in patients admitted with a diagnosis of COVID-19 in Peymaniyeh Hospital in Jahrom, Iran. Ethical considerations: Before entering the patients in this study, the research process was explained and informed consent was obtained from them. IRB: This study was approved by the ethics committee of Jahrom University of Medical Sciences under the ethical code IR.JUMS.REC.1399.003 and was registered in the Iranian registry of clinical trials under the number IRCT20200415047082N1.
   Sex as a biological variable	Inclusion criteria: Patients admitted with COVID-19 with a definitive diagnosis of PCR test, having age over 18 years, and not being pregnant or lactating.
   Randomization	Study design: The present study is a double-blind, randomized clinical trial that was conducted over three months from April 2020 to June 2020 in patients admitted with a diagnosis of COVID-19 in Peymaniyeh Hospital in Jahrom, Iran. Ethical considerations: Before entering the patients in this study, the research process was explained and informed consent was obtained from them.
   Blinding	not detected.
   Power Analysis	Sample size assuming standard difference=0.85 and confidence limits of 95% and power = 80% and assuming an equal number of samples in each group using Altman nomogram and taking into account 15% precipitation, 70 Person was determined.

   Table 2: Resources

   Software and Algorithms
   Sentences	Resources
   In the case of sugarcane, according to the American Heart Association (AHA), the permissible daily intake of sugar for women is 6 teaspoons equivalent to 25 grams, and for men, 9 teaspoons equivalent to 36 grams; in our study, 3 grams sugarcane per day (1.5 grams BID) was used based on the TIM principles, which was safe based on the AHA principles, too.	American Heart Association suggested: (American Heart Association, RRID:SCR_007210)

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   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).

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   Results from LimitationRecognizer: We detected the following sentences addressing limitations in the study:

   But we were not able to monitor conventional antipyretic use in these patients and as a confounding factor, this was a limitation of our study; while for fever control, all patients had the same physician medical order. The active ingredients of black myrobalan are terpenoids, carotenoids, flavonoids, alkaloids, tannins, and glycosides (Vemuri et al., 2019). In studies, this plant has been mentioned as a rich flavonoid plant (Sharma et al., 2019). While we did not have the opportunity of chemical constituent compounds analysis of herbs; previous administrations of black myrobalan were shown to be safe in humans. AyuFlex herbal, manufactured by Natreon Inc., New Jersey, USA, is a US FDA approved black myrobalan supplement (Murali et al., 2007). Black myrobalan has antiviral, antifungal, and antibacterial activity due to containing a variety of molecules. Black myrobalan has been reported to be an effective antiviral agent against swine flu type A, HSV-1, HIV-1 has been reported in various studies (Lopez et al., 2017; Ma et al., 2010). Other molecules in this plant are gallic acid and 3-glycol glucose molecules that inhibit the process of HIV-1 integration (Yukawa et al., 1996; Kim et al., 2001; Ardekani et al., 2011) and thus prevent viral infection without any side effects. Black myrobalan extract is effective in inhibiting the division of cytomegalovirus and is useful in people with immune deficiencies (Ahn et al., 2002; Nosalova et al., 2013; aik et al., 2004); The effect o...

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   Results from TrialIdentifier: No clinical trial numbers were referenced.

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

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

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   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.

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

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   Version published to 10.1101/2021.04.27.21256221v1 on medRxiv

   Apr 28, 2021