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TGIR for Healthy Subjects
Study Summary
This trial tests a natural remedy to see if it has any side-effects or pain-relieving properties in healthy people.
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Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- You have taken pain medication within the last 7 days.You have tested positive for COVID-19 or are showing symptoms of COVID-19.You cannot take supplements that contain certain herbs known to cause drowsiness, like valerian, skullcap, hops, california poppy, passiflora, and cannabis while participating in the study.You are between the ages of 18 and 65.You report being in good health.You are capable and inclined to adhere to the research plan.You do not have a diagnosis of chronic pain.You have a history or current diagnosis of a significant medical condition that may make it unsafe or difficult for you to participate in the study.You have a serious medical or mental health condition.
- Group 1: TGIR (Traditional Gastrointestinal Remedy)
- Group 2: Control (Microcrystalline cellulose)
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Are there still spots available for participants in this experiment?
"Affirmative. Accessing the data on clinicaltrials.gov reveals that this medical trial is presently open for recruitment and was originally posted on November 1st 2022. The study has a current target of 24 patients from one site, with the most recent update occuring March 13th 2023."
Is it feasible to join this medical study?
"To qualify for this clinical trial, potential participants must lie within the age bracket of 18 and 65 years old with no existing medical conditions. 24 individuals in total will be accepted into the study."
Has TGIR been certified by the FDA?
"Based on the Phase 4 status of TGIR, our team concluded that this traditional gastrointestinal remedy was safe and assigned it a score of 3."
Is this research program open to octogenarians?
"Individuals aged 18-65 are suitable for this clinical trial, however there are separate trials available to those under the age of eighteen as well as those over 65. Specifically, 54 and 372 such studies respectively."
How many research participants are currently engaged in this investigation?
"Affirmative. According to the data hosted on clinicaltrials.gov, this medical trial is actively seeking participants - which was first published on November 1st 2022 and last edited March 13th 2023. 24 volunteers need to be recruited from a single centre for the study."
Who else is applying?
What state do they live in?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
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