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.

NCT06689995 | Completed

• 1 other identifier: NB240047-AP
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Upper Respiratory Tract Infection

Outcome Measures

Primary Outcomes (2)

• To assess the effect of the test treatment on symptom severity and functional impairment scores as measured by the Wisconsin Upper Respiratory Symptom Survey-21 (WURSS-21) questionnaire, compared to placebo

  Each symptom is rated on a 7-point scale, where "0" denotes "no symptom" and "7" denotes "severe symptoms."

  on Day 1 (before administration) for baseline and 6 hours post-dosage, and later on Day 2, Day 3, and Day 5

• To assess the effect of the test treatment on the overall symptom burden of the common cold, as determined by the Area Under the Curve (AUC) for the WURSS-21 symptom, functional impairment, and global scores, compared to placebo.

  Each symptom is rated on a 7-point scale, where "0" denotes "no symptom" and "7"

  on Day 1 (before administration) for baseline and 6 hours post-dosage, and later on Day 2, Day 3, and Day 5

Secondary Outcomes (43)

• To assess the effect of the test treatment on symptoms (such as cough), using a Visual Analogue Scale (VAS), compared to placebo.

  on Day 1 (before administration) for baseline and 6 hours post-dosage, and later on Day 2, Day 3, and Day 5

• To assess the effect of the test treatment on symptoms (such as expectoration), using a Visual Analogue Scale (VAS), compared to placebo.

  on Day 1 (before administration) for baseline and 6 hours post-dosage, and later on Day 2, Day 3, and Day 5

• To assess the effect of the test treatment on symptoms (such as nasal discharge), using a Visual Analogue Scale (VAS), compared to placebo.

  on Day 1 (before administration) for baseline and 6 hours post-dosage, and later on Day 2, Day 3, and Day 5

• To assess the effect of the test treatment on symptoms (such as headache), using a Visual Analogue Scale (VAS), compared to placebo.

  on Day 1 (before administration) for baseline and 6 hours post-dosage, and later on Day 2, Day 3, and Day 5

• To assess the effect of the test treatment on symptoms (such as fever), using a Visual Analogue Scale (VAS), compared to placebo.

  on Day 1 (before administration) for baseline and 6 hours post-dosage, and later on Day 2, Day 3, and Day 5

Study Arms (2)

Bio-immune Capsule

EXPERIMENTAL

Dosage Form: Capsule Route of administration: Oral Frequency: 1 capsule, twice a day after meal for 5 days Dose: 100 mg

Other: Bio-immune Capsule

Placebo Capsule

PLACEBO COMPARATOR

Dosage Form: Capsule Route of administration: Oral Frequency: 1 capsule, twice a day after meal for 5 days Dose: 100 mg

Other: Placebo

Interventions

Bio-immune Capsule OTHER

Dosage Form: Capsule Route of administration: Oral Frequency: 1 capsule, twice a day after meal for 5 days Dose: 100 mg

Bio-immune Capsule

Placebo OTHER

Dosage Form: Capsule Route of administration: Oral Frequency: 1 capsule, twice a day after meal for 5 days

Placebo Capsule

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. The age of subject is ≥30 years and \<80 years. 2. The subject is a healthy male or a healthy adult non-pregnant and non-lactating female.
• \. The subject is suffering from uncomplicated URTI characterized by symptoms such as cough, nasal discharge, sore throat, or has had the first fever spike within 48 hours of enrolment.
• \. The subject must be willing to comply with all study procedures and restrictions, including taking the test treatment as directed, completing the WURSS-21 questionnaire, and undergoing laboratory assessments.
• \. The subject must provide written informed consent prior to participation in the study.
• \. The subject is in a stable medical condition, not requiring immediate intervention or hospitalization.
• \. If the subject is female, she is willing to use a highly effective method of contraception throughout the clinical investigation.
• Females of childbearing potential must practice and maintain an established method of birth control (e.g., IUD, hormonal implant device/injection, birth control pills, diaphragm, condoms with spermicide, partner vasectomy, or abstinence).
• Non-childbearing potential females who are surgically sterile, post-menopausal for at least 1 year, or have had a tubal ligation, must have been using hormonal contraception for at least 6 months and agree to continue using the same contraception for the study duration.

You may not qualify if:

• \. The subject is currently diagnosed with active respiratory infections or diseases other than uncomplicated URTI that might require immediate medical attention or intervention will be excluded.
• \. The chest X-ray of the subject, performed within the past 28 days, reveals significant respiratory disorders or other serious conditions that might interfere with the study or necessitate medical intervention.
• \. Laboratory tests (blood and urinalysis) performed at the screening visit reveal significant infective or other serious conditions that could interfere with the study or necessitate medical intervention.
• \. The subject has known immunocompromising conditions such as HIV/AIDS, or those undergoing immunosuppressive therapy.
• \. The subject has other significant respiratory diseases (e.g., COPD, asthma, interstitial lung disease, active tuberculosis).
• \. The subject has uncontrolled or severe cardiovascular, renal, or hepatic conditions.
• \. The subject has participated in any other clinical trial within 30 days prior to the screening visit.
• \. The subject is pregnant/lactating, or is planning on become pregnant during the course of the study.
• \. The subject has known hypersensitivity or allergies to any component of the test treatment or similar botanical extracts are excluded.
• \. The subject is on regular medications known to interfere with the study outcomes (e.g., systemic corticosteroids, antiviral drugs) within 4 weeks before screening are excluded.
• \. The subject has any condition that, in the investigator's judgment, would compromise the subject's safety or study integrity.

Sponsors & Collaborators

• NovoBliss Research Pvt Ltd: lead
• Ambe Phytoextracts Pvt. Ltd: collaborator

Study Sites (1)

NovoBliss Research Pvt.Ltd

Ahmedabad, Gujarat, 382481, India

Location

MeSH Terms

Conditions

Respiratory Tract Infections

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases

Study Officials

• Dr. Nayan K Patel

  NovoBliss Research Pvt Ltd

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double Blind
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2024
• First Posted: November 15, 2024
• Study Start: December 30, 2024
• Primary Completion: January 29, 2025
• Study Completion: January 29, 2025
• Last Updated: February 28, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)