NCT06689995

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.

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: NovoBliss Research Pvt Ltd · Academic / Other
• Sex: All
• Age: 30 Years – 80 Years
• Healthy volunteers: Accepted

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.

Conditions

• Upper Respiratory Tract Infection

Interventions

Type	Name	Description
OTHER	Bio-immune Capsule	Dosage Form: Capsule Route of administration: Oral Frequency: 1 capsule, twice a day after meal for 5 days Dose: 100 mg
OTHER	Placebo	Dosage Form: Capsule Route of administration: Oral Frequency: 1 capsule, twice a day after meal for 5 days

Timeline

• Start date: 2024-12-30
• Primary completion: 2025-01-29
• Completion: 2025-01-29
• First posted: 2024-11-15
• Last updated: 2025-02-28

Locations

1 site across 1 country: India