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• 15 out of the 36 sufferers skilled Sensory Dysfunction previous to receiving remedy. Amongst these 15 sufferers, 5 recovered their sensory features whereas the remaining 10 confirmed enhancements on the finish of the 6-day remedy interval.
• 31 out of 37 COVID-19 sufferers, representing roughly 83.8% of sufferers, reported the elimination of a number of signs after taking 1 full dose of RGC-COV19TM (1 day of remedy) with the most important variety of signs eradicated after 1 day of remedy being 7.
• Out of the 37 sufferers, 9 sufferers skilled a mixture of dyspnea (problem respiratory) and protracted chest ache. 6 of those 9 sufferers now not skilled problem respiratory and/or persistent chest ache after 1 full dose of RGC-COV19TM.
• All 23 sufferers who began taking RGC-COV19TM inside 3 days from signs onset took a mean of roughly 3.2 days for the elimination of all signs, save for Sensory Dysfunction and occasional cough.
• All 14 sufferers who began taking RGC-COV19TM between 4 to five days from signs onset took a mean of roughly 3.6 days for the elimination of all signs, save for Sensory Dysfunction and occasional cough.
Hong Kong–(ANTARA/Enterprise Wire)- Regencell Bioscience Holdings Restricted (NASDAQ: RGC) (“Regencell” or the “Firm”) at this time introduced the outcomes from an evaluation of a complete of 37 people enrolled in its Evaluation and Assessment of RGC-COV19TM TCM via a Holistic method (“EARTH”) efficacy trial carried out by Regencell Bioscience Asia Restricted (“Regencell Asia”) of its novel COVID-19 oral TCM candidate RGC-COV19TM (Regencell Bioscience (RGCA-CV01) liquid formulation). The outcomes have but to be peer reviewed. Upon profitable completion of the EARTH efficacy trial, RGC-COV19TM may very well be used extra broadly for the remedy of the inhabitants who search a pure and holistic method to successfully scale back and get rid of COVID-19 signs and to scale back the chance of hospitalization and demise.
“The outcomes of EARTH mark an essential journey for the Firm in its aim to avoid wasting and enhance lives of sufferers all all over the world. As COVID-19 circumstances proceed to rise globally in 2022, there may be an urgency to discover a holistic method in the direction of treating COVID-19. By establishing Regencell Asia and thru EARTH’s preliminary findings, we hope the method of discovering another, pure remedy for COVID-19 can be accelerated. These outcomes spotlight the potential of providing a pure and holistic remedy for COVID-19,” mentioned Ji Yang Lee (Jay), Chief Government Officer and Co-Founding father of Regencell Asia.
About EARTH Efficacy Trial
The first goal of EARTH is to guage and assess the efficacy of Regencell Bioscience’s TCM – RGC-COV19TM (Regencell Bioscience (RGCA-CV01) liquid formulation) in lowering and eliminating COVID-19 signs via a holistic method inside a 6-day interval.
EARTH was a non-blinded efficacy trial carried out from 1 October 2021 till 31 January 2022. The eligibility standards required that every one sufferers had laboratory affirmation of SARS-CoV-2 an infection inside 3 days previous to remedy and with signs onset inside 5 days previous to remedy.
Based mostly on the above-mentioned standards, sufferers who have been asymptomatic have been rejected and 37 random people ultimately certified for enrolment and have been enrolled. The enrolled sufferers have been between the ages of 5 to 61 and of various races, ethnic backgrounds and socioeconomic backgrounds. 23 people have been primarily based in Kuala Lumpur and Seremban, Malaysia whereas the opposite 14 people have been primarily based in California, america. 23 out of the 37 enrolled sufferers began taking RGC-COV19TM inside 3 days of signs onset and the remaining 14 sufferers began taking RGC-COV19TM between 4 to five days of signs onset.
In conducting EARTH, Regencell Asia set a most of 6 days of remedy per affected person. Enrolled sufferers have been required to report their COVID-19 signs day by day in line with 3 severity classes (delicate, average, extreme) and the record contained signs akin to fever, fatigue, cough, sore throat, runny nostril, headache, nausea, feeling scorching, chills, drowsy, shortness of breath, persistent chest ache or strain, muscle ache and stomach discomfort. Sufferers have been additionally requested to establish every other signs that they have been experiencing. Every affected person obtained 2 days of remedy progressively whereas a reverse transcription polymerase chain response (RT-PCR) check for sufferers in Malaysia was carried out each 2 days.
Each time a affected person’s RT-PCR check outcome turned detrimental or sufferers now not had any COVID-19 signs (save for Sensory Dysfunction or occasional cough) inside the 6-day remedy interval, the remedy ended. Whereas receiving the TCM remedy, 3 of them weren’t vaccinated, 3 have been partially vaccinated and 31 have been totally vaccinated. On the finish of the remedy, the overall variety of sufferers whose signs have been utterly eradicated inside the 6-day remedy interval, save for Sensory Dysfunction and occasional cough, have been recorded to find out the efficacy.
About EARTH’s Outcomes
Efficacy of full signs elimination inside the 6-day remedy interval
Out of the 37 COVID-19 sufferers, 36 sufferers had all signs eradicated, save for Sensory Dysfunction and occasional cough, inside the 6-day remedy interval. Our efficacy trial confirmed that after taking RGC-COV19TM, 97.3% of the sufferers had their delicate to average COVID-19 signs eradicated, save for Sensory Dysfunction and occasional cough, inside the 6-day remedy interval. 15 out of the 36 sufferers skilled Sensory Dysfunction previous to receiving remedy. Amongst these 15 sufferers, 5 recovered their sensory features whereas the remaining 10 confirmed enhancements on the finish of the 6-day remedy interval.
Out of the 36 sufferers, the variety of days it took for all signs to be eradicated, save for Sensory Dysfunction and occasional cough, inside the 6-day remedy interval, was 1 day = 6 sufferers, 2 days = 7 sufferers, 3 days = 5 sufferers, 4 days = 11 sufferers, 5 days = 4 sufferers, and 6 days = 3 sufferers.
Signs elimination after 1 full dose of RGC-COV19TM
31 out of 37 COVID-19 sufferers, representing roughly 83.8% of sufferers, reported the elimination of a number of signs after taking 1 full dose of RGC-COV19TM, with the most important variety of signs eradicated after 1 day of remedy reported by a affected person being 7. The typical variety of days it took from the beginning of remedy for all 37 COVID-19 sufferers to get rid of all signs, save for Sensory Dysfunction and occasional cough, was roughly 3.4 days. The most important variety of totally different signs reported by sufferers was 14 and the typical variety of totally different signs reported was roughly 6.
Malaysia – remedy resulting in detrimental RT-PCR
Out of the 23 sufferers from Malaysia, 10 sufferers (representing roughly 43.48%) examined detrimental RT-PCR inside the 6 days remedy (Adverse RT-PCR in 2 days = 4 sufferers, 4 days = 4 sufferers, 5 days = 1 affected person, 6 days = 1 affected person). Because the begin of the remedy, the typical days taken for these 10 sufferers to check detrimental is 3.5 days. The minimal and most days taken for sufferers to check detrimental was 2 and 6 days, respectively. The remaining 13 sufferers had all signs eradicated, save for Sensory Dysfunction and occasional cough, inside 6 days (common roughly 3.5 days) and subsequently was not additional examined for COVID-19.
Taking the remedy inside 3 days from signs onset vs inside 4 to five days from signs onset
Additional evaluation confirmed that the 23 sufferers who began taking RGC-COV19TM inside 3 days from signs onset took a mean of roughly 3.2 days for the elimination of all signs, save for Sensory Dysfunction and occasional cough, whereby the utmost variety of totally different signs reported by anyone particular person was 14 and the typical variety of totally different signs reported was 5.
The remaining 14 sufferers who began taking RGC-COV19TM between 4 to five days from signs onset took a mean of roughly 3.6 days for the elimination of all signs, save for Sensory Dysfunction and occasional cough, whereby the utmost variety of totally different signs reported by anyone particular person was 13 and the typical variety of signs reported was 7.
Vaccination standing
The three sufferers who weren’t vaccinated reported a mean of three signs every and all 3 sufferers took a mean of roughly 2.3 days for signs to be eradicated. The three sufferers who have been partially vaccinated reported a mean of three signs every and took a mean of roughly 3.3 days for all signs to be eradicated, save for Sensory Dysfunction. 1 of those 3 sufferers examined detrimental RT-PCR after 4 days of remedy. The remaining sufferers who have been totally vaccinated reported a mean variety of 6 signs every and these sufferers took a mean of roughly 3.5 days for all signs to be eradicated, save for Sensory Dysfunction and occasional cough. All sufferers who have been vaccinated both obtained a single dose, double dose, or a mixture of vaccine from Pfizer-BioNTech, Moderna, AstraZeneca, Sinovac-CoronaVac and/or Johnson & Johnson’s Janssen.
Excessive-risk sufferers
Out of the 37 sufferers, 9 sufferers skilled a mixture of dyspnea (problem respiratory) and protracted chest ache. 6 of those 9 sufferers now not skilled problem respiratory and/or persistent chest ache after 1 full dose of RGC-COV19TM.
No hostile negative effects
Based mostly on the sufferers’ self-reported knowledge, there have been no worsening of signs throughout and after consuming RGC-COV19TM and not one of the sufferers skilled any unknown hostile negative effects.
No remedy emergent hostile occasions
Among the many 3 sufferers with comorbidities akin to systemic lupus erythematosus (SLE), bronchial asthma and most cancers, there have been no remedy emergent hostile occasions and no discontinuation of RGC-COV19TM as a result of hostile outcomes.
Dying/Hospitalization
On the finish of the EARTH efficacy trial, not one of the sufferers was hospitalized and there was no demise. The efficacy of RGC-COV19TM was not affected by timing of symptom onset or underlying danger issue. Outcomes have been constant throughout all ages, gender, races and ethnicity demographic among the many enrolled sufferers.
Extra about EARTH
There are lots of of tens of millions of people who’ve been recognized with COVID-19 all over the world, and a few expertise post-COVID signs akin to excessive tiredness (fatigue), shortness of breath, issues with reminiscence and focus (mind fog), coronary heart palpitations, dizziness, chest ache or tightness, joint ache which at the moment are being categorized as long-COVID signs.
As long-COVID signs have substantial results on people’ high quality of life and work functionality, Regencell Asia is within the midst of conducting its research for long-COVID sufferers utilizing a pure and holistic system – RGC-COV19TM (RGCA-LCV01).
About RGC-COV19TM
RGC-COV19TM (RGCA-CV01) is an investigational, pure, orally administered liquid system which goals to scale back and get rid of COVID-19 signs.
RGC-COV19TM will be taken safely for 2 to 3 weeks. In conducting EARTH, the remedy was restricted to six days to be able to consider its efficacy in lowering and eliminating COVID-19 signs.
Regencell started its investigational method in the direction of COVID-19 remedy when a buddy of Regencell contracted COVID-19 in March 2020 and the TCM Practitioner used his proprietary TCM system which he has been utilizing over the previous 30 years to deal with numerous chilly and flu sufferers, together with through the 2003 SARS outbreak, to deal with him. The TCM Practitioner subsequently handled 9 voluntary COVID-19 sufferers in america. The “TCM Practitioner” refers to our strategic TCM analysis associate, Sik-Kee Au, father of our founder and Chief Government Officer.
Examine outcomes confirmed that the remedy was efficient. As Regencell has a aim to avoid wasting lives, enhance sufferers’ well-being and deal with unmet wants available in the market, Regencell needs to make its pure and holistic remedy out there to folks in want.
From March 2020 to August 2021, Regencell arrange protocols and procedures to conduct the EARTH efficacy trial in Malaysia and america.
RGC-COV19TM makes use of pure elements to stimulate the physique’s personal therapeutic mechanism and the drugs successfully reduces COVID-19 signs akin to fever, fatigue, cough, sore throat, runny nostril, headache, nausea, chills, drowsiness, shortness of breath, persistent chest ache and muscle ache as the drugs works to (i) scale back and clear the mucus and phlegm from the higher respiratory system; (ii) dispel exterior viral pathogen by way of heavy sweats, urine and excrement; (iii) clear endogenous and liver warmth; (iv) detox the liver; and (v) enhancing physique circulation.
By making use of the TCM Practitioner’s “Sik-Kee Au TCM Mind Idea®”, RGC-COV19TM removes blood clots from the mind therefore restoring the affected person’s numerous mind features.
RGC-COV19TM (RGCA-CV01) is run at 1 dose of RGCA-CV01-1Na (roughly 230ml) and 1 dose of RGCA-CV01-2Da (roughly 230ml) every time, with 1 dose of RGCA-CV01-1Na to be taken ranging from the evening of the primary day of remedy and 1 dose of RGCA-CV01-2Da to be taken after lunch the subsequent day, till signs are eradicated.
About Regencell Bioscience Holdings Restricted and Regencell Bioscience Asia Restricted: Breakthrough in TCM formulae designed to avoid wasting and enhance lives
For greater than 30 years, the TCM Practitioner whom Regencell Bioscience companions with has handled sufferers with neurological issues and infectious ailments. The TCM Practitioner’s TCM formulae candidates are derived from a TCM base system and an adjustable system which is developed primarily based on his TCM mind principle, referred to as the “Sik-Kee Au TCM Mind Idea®”.
Each Regencell Bioscience and the TCM Practitioner are dedicated in giving again to the society and demonstrates its CARE via Caring for sufferers, Accountability by sustaining a excessive normal of high quality and integrity, Respect by valuing partnerships, teamwork and concord and the Enthusiasm to enhance the lifetime of the underprivileged.
Ahead-looking Statements
Contacts
Investor Relations
James Chung
+852 2155 0823
Supply: Regencell Bioscience Holdings Restricted
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