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:
2025-12-24 @ 2:08 PM
Ignite Modification Date:
2025-12-24 @ 2:08 PM
NCT ID:
NCT06689995
Brief Summary:
This is a prospective, interventional, randomised, double-blind, placebo-controlled, proof-of-science, in-use safety and efficacy study of an oral supplementation of Bio-Immune® for managing upper respiratory tract infection and its symptoms.
Detailed Description:
A total of 54 human adults (27/arm) aged 30-80 years with uncomplicated Upper Respiratory Tract Infection will be enrolled to ensure the completion of 50 subjects (25/arm).
Potential subjects will undergo screening based on predefined inclusion and exclusion criteria only after obtaining written informed consent. The subject recruitment department will contact the potential subjects via telephone before the enrolment visit to confirm their participation.
Subjects shall be instructed to visit the facility for the following scheduled visits:
* Visit 1 \[within 2 days\]: Screening, evaluations for inclusion.
* Visit 2 \[Day 1\]: Enrolment, baseline and post-baseline evaluations, treatment commencement.
* Visit 3 \[Day 2\]: Test treatment usage phase, follow-up evaluations.
* Visit 4 \[Day 3\]: Test treatment usage phase, follow-up evaluations.
* Visit 5 \[Day 5 (+1 day)\]: End-of-study visit, follow-up Evaluations.
Study:
NCT06689995
Study Brief:
Protocol Section:
NCT06689995