Endourage Begins Human Clinical Trial to Test If Proprietary Hemp-Flower Formulation Eases Symptoms of Post-Acute COVID-19 Syndrome

It will measure the efficacy and safety of Formula C for people with (PACS).

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Tuesday, April 13, 2021
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Alternative medicine, Retail, Health, Infectious diseases, Tobacco, Clinical trials, Pharmaceutical, Clinical trials, Clinical research, Design of experiments, Drugs, Health, Medical research, Orphan drugs, Anti-inflammatory agents, Placebo-controlled study, Cannabidiol, Placebo, Open-label trial
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United States, Colorado, DENVER
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Summary
Key Points: 
  • It will measure the efficacy and safety of Formula C for people with (PACS).
  • The study is a single blind, placebo-controlled trial with an open label arm.
  • Participants will not know if they are receiving the Formula C which includes terpenes and cannabidiol (CBD), or the placebo during the first 28-day arm.
  • Sterling\xe2\x80\x99s mandate is to ensure compliance with federal regulations to protect the rights and welfare of human participants in research studies.\nView source version on businesswire.com: https://www.businesswire.com/news/home/20210413005424/en/\n'


Denver-based Endourage (www.endourage.com) received authorization from an Institutional Review Board (IRB) for its Phase IV clinical trial to evaluate the efficacy of its proprietary hemp flower CBD formulation, Targeted Wellness Formula C (Formula C), in attenuating the symptoms of Post-Acute COVID-19 Syndrome (PACS).

Tens of thousands of Americans have endured persistent, lingering symptoms of COVID-19 months after the virus is no longer detected in their bodies, an affliction known as Post-Acute COVID-19 Syndrome (PACS). Symptoms can include shortness of breath, fatigue, body aches and headaches, as well as difficulty sleeping, exercising, and concentrating (also known as “brain fog”).

The study will include 60 participants who meet the inclusion criteria. It will measure the efficacy and safety of Formula C for people with (PACS). The study is a single blind, placebo-controlled trial with an open label arm. Participants will not know if they are receiving the Formula C which includes terpenes and cannabidiol (CBD), or the placebo during the first 28-day arm. All participants will know that they are taking Formula C during the second arm. Formula C is a blend of several different chemovars of the hemp plant, a formula designed to address symptoms including inflammation, anxiety, and depression, says Dr. Michael Steward, Chief Medical Officer at Endourage.

“It is incredibly frustrating for doctors to not be able to provide effective care for their patients,” Steward says. “I am excited that it appears we may have found a significant tool for clinicians who are treating those who are suffering.”

Although lingering symptoms of COVID-19 are more likely to occur in older people and those with chronic illnesses, people without those risk factors are also affected. And the severity of the disease isn’t always an indicator that a patient will face PACS. Patients who suffered a serious case of COVID can recover to normal function, while those who were only mildly affected can still experience long-term symptoms.

The Endourage clinical trial was approved by Sterling IRB, an institutional review board registered with US Department of Health and Human Service. Sterling’s mandate is to ensure compliance with federal regulations to protect the rights and welfare of human participants in research studies.

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