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临床试验/NCT06163690
NCT06163690已完成不适用

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

Endourage, LLC1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2023年12月13日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
1
主要终点
Symptom and wellbeing change over 3 months

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
21 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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

结局指标

主要结局

Symptom and wellbeing change over 3 months

时间窗: 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.

次要结局

  • Patient Global Impression of Change(90 days)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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