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OpenTrials
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NCT Number: NCT06163690

Symptom Tracking in Long COVID Patients Using Formula C™ Sublingual Drops

This is a digital symptom tracking study of Formula C™, a full cannabis flower formulation, rich in cannabinoids and terpenes, that has been shown to improve symptoms in people with Long COVID. Participants 21 and older will take Formula C™ for 90 days. During that time, participants will answer weekly surveys to track symptoms and wellbeing.

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Key information

About this study

Long COVID is a global health crisis with no current treatments. There's a growing interest within the medical community to explore the potential benefits of full hemp flower extracts in treating and alleviating Long COVID symptoms. Full hemp flower extracts are a remarkable advancement in the field of natural wellness and healing. Full hemp flower extracts harness the full spectrum of beneficial compounds present in the hemp plant, including not just cannabidiol (CBD), but a host of other cannabinoids, terpenes, and flavonoids. This process, known as 'whole plant' or 'full spectrum' extraction, produces a more potent and therapeutic product, as the various compounds work synergistically in what is referred to as the 'entourage effect'. These extracts have been associated with a broad range of potential health benefits, such as pain relief, reduction of inflammation, anxiety management, and sleep improvement. A recently published single-blind, randomized, placebo controlled trial demonstrated that Long COVID patients benefitted from sublingual use of Formula C without any safety events. This remote, observational study of Endourage Targeted Wellness Formula C™ sublingual drops will seek to empower participants to track symptoms and wellbeing while taking Formula C to determine if Long COVID symptoms are attenuated and time to healing is shortened.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Must be at least 21 years of age.
  • Willing and able to read, understand, and sign the informed consent.
  • Willing to comply with all study procedures.
  • Must have device to access the internet to complete surveys online.
  • A diagnosis of Long COVID from a health care provider.

Exclusion criteria

  • Non-English speaking, as the surveys are developed in the English language.
  • Known allergies to hemp seeds or hemp-derived products, medical cannabis, coconut oil.
  • Pregnancy, or planning to become pregnant in the next 3 months

Treatment and study plan

Endourage Targeted Wellness Formula C™, a full hemp flower extract

Combination Product

A hemp-derived formulation designed as a daily use adjunctive therapy to help improve Long COVID symptoms. Endourage Targeted Wellness Formula C™ are used as sublingual drops held under the tongue for 60 to 90 seconds.

Primary outcomes

  1. Symptom and wellbeing change over 3 months

    Time frame: 90 days

    This study will use the PROMIS-29+2 Profile v2.1 (PROPr) is used to calculate a change in Long COVID related symptoms including fatigue, sleep, pain, mood and physical function.

Secondary outcomes

  1. Patient Global Impression of Change

    Time frame: 90 days

    The self-report measure Patient Global Impression of Change (PGIC) reflects a patient's belief about the efficacy of treatment.

Sponsors and collaborators

Lead sponsor

Endourage, LLC

Industry

Registry information

Official study title

Digital Symptom Tracking and Wellness in Long COVID Patients Using Endourage Targeted Wellness Formula C™ Sublingual Drops

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Dec 11, 2023
Registry last updated
Feb 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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