Ignite Creation Date:
2025-12-24 @ 2:08 PM
Ignite Modification Date:
2026-02-10 @ 7:02 PM
Study NCT ID:
NCT06689995
Status:
COMPLETED
Last Update Posted:
2025-02-28
First Post:
2024-10-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Clinical Study to Determine the Safety and Efficacy of an Oral Supplementation of Bio-Immune®for Managing Upper Respiratory Tract Infection and Its Symptoms.
Sponsor:
NovoBliss Research Pvt Ltd
Organization:
Study Overview
Official Title:
An Investigation of the Safety and Effectiveness of an Oral Supplementation of Bio-Immune® for Managing Upper Respiratory Tract Infection and Its Symptoms: A Prospective, Interventional, Randomised, Double-Blind, Placebo-Controlled, Proof-of-Science Study.
Status:
COMPLETED
Status Verified Date:
2025-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: