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

NCT ID: NCT06163690

Last Updated: 2025-02-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-12-13

Study Completion Date

2025-01-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Long COVID Long Covid19 Post-Acute COVID-19 Post-Acute COVID-19 Syndrome Long Haul COVID Long-Haul COVID-19

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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

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.

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Endourage, LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael Steward, MD

Role: PRINCIPAL_INVESTIGATOR

Endourage, LLC

Locations

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Endourage, LLC

Denver, Colorado, United States

Site Status

Countries

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United States

References

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Young TP, Erickson JS, Hattan SL, Guzy S, Hershkowitz F, Steward MD. A Single-Blind, Randomized, Placebo Controlled Study to Evaluate the Benefits and Safety of Endourage Targeted Wellness Formula C Sublingual +Drops in People with Post-Acute Coronavirus Disease 2019 Syndrome. Cannabis Cannabinoid Res. 2024 Feb;9(1):282-292. doi: 10.1089/can.2022.0135. Epub 2022 Oct 14.

Reference Type BACKGROUND
PMID: 36252151 (View on PubMed)

Other Identifiers

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Endo2023

Identifier Type: -

Identifier Source: org_study_id

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