Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 1:14 AM
Ignite Modification Date:
2025-12-25 @ 1:14 AM
NCT ID:
NCT05783193
Brief Summary:
The primary research objective of this study is to confirm the absence of side-effects and explore any analgesic properties of the botanical formulation TGIR (Traditional Gastrointestinal Remedy) in healthy participants.
Detailed Description:
This study is a randomized, placebo-controlled, crossover, clinical trial with 24 healthy volunteers. Participants will be randomized to receive each of the two treatments, TGIR (500mg/capsule, total 1.0g) followed by Placebo (2 matching capsules), or vice-versa, with a week between treatments. Participants will remain in the clinic for a 4-hr observation period each day for a total of 2 clinic visits. During the course of treatment, participants will receive physiological monitoring: heart rate and blood pressure. Any adverse events and side effects will be documented throughout the study, in addition to participant feedback and perceived effects. On each day of treatment (TGIR and placebo-control), participants will receive a standardized test of analgesia using Brief Thermal Sensitization (BTS) and measures of reaction time using a computer-based Psychomotor Vigilance Task (PVT).
Study:
NCT05783193
Study Brief:
Protocol Section:
NCT05783193