Safety and Efficacy Study of oral supplement Bio-Immune® to manage Upper Respiratory Tract Infection.
Scientific Title of Study
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.
Trial Acronym
Nil
Secondary IDs if Any
Secondary ID
Identifier
NB240047-AP, 1.0 , 30 Sep 24
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Dosage Form: Capsule
Dose: 100 mg
Route of administration: Oral
Frequency: 1 capsule, twice a day after meal for 5 days.
Comparator Agent
Placebo Capsule
Storage Condition: Store in cool & dry place
Dosage Form: Capsule
Dose: 100 mg
Route of administration: Oral
Frequency: 1 capsule, twice a day after meal for 5 days.
Inclusion Criteria
Age From
30.00 Year(s)
Age To
80.00 Year(s)
Gender
Both
Details
1. The age of subject is more than or equal to 30 years and less than 80 years.
2. The subject is a healthy male or a healthy adult non-pregnant and non-lactating female.
3. 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.
4. 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.
5. The subject must provide written informed consent prior to participation in the study.
6. The subject is in a stable medical condition, not requiring immediate intervention or hospitalization.
7. If the subject is female, she is willing to use a highly effective method of contraception throughout the clinical investigation.
a. Females of childbearing potential must practice and maintain an established method of birth control (IUD, hormonal implant device/injection, birth control pills, diaphragm, condoms with spermicide, partner vasectomy, or abstinence).
b. 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.
ExclusionCriteria
Details
1. 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.
2. 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.
3. 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.
4. The subject has known immunocompromising conditions such as HIV/AIDS, or those undergoing immunosuppressive therapy.
5. The subject has other significant respiratory diseases (COPD, asthma, interstitial lung disease, active tuberculosis).
6. The subject has uncontrolled or severe cardiovascular, renal, or hepatic conditions.
7. The subject has participated in any other clinical trial within 30 days prior to the screening visit.
8. The subject is pregnant/lactating, or is planning on become pregnant during the course of the study.
9. The subject has known hypersensitivity or allergies to any component of the test treatment or similar botanical extracts are excluded.
10. The subject is on regular medications known to interfere with the study outcomes (systemic corticosteroids, antiviral drugs) within 4 weeks before screening are excluded.
11. The subject has any condition that, in the investigator judgment, would compromise the subject safety or study integrity.
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Centralized
Blinding/Masking
Participant and Investigator Blinded
Primary Outcome
Outcome
TimePoints
1. 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.
2. 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.
scores on Day 1 (before administration) for baseline and 6 hours post-dosage, and later on Day 2, Day 3, and Day 5.
Secondary Outcome
Outcome
TimePoints
To assess the effect of the test treatment on symptoms (such as cough, expectoration, nasal discharge, headache, fever, sore throat, earache, and malaise/fatigue), 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 cough, expectoration, nasal discharge, headache, fever, sore throat, earache, and malaise/fatigue), using the Numeric Rating Scale (NRS) by clinical evaluation for each symptom, 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 daily nasal discharge in terms of nasal mucus weight measured using pre-weighed paper tissues, compared to placebo.
on Day 1 (before administration) for baseline, and later on Day 2, and Day 3
To assess the safety of the test treatment by monitoring the occurrence of any adverse events throughout the study period.
To assess the safety of the test treatment by monitoring the occurrence of any adverse events throughout the study period.
To assess the safety of the test treatment based on changes in blood parameters, including Complete Blood Count (CBC).
on Day 1 (before administration) for baseline, and post-dosage on Day 3
To assess the effectiveness of the test treatment in altering C-reactive protein levels in blood, compared to placebo.
on Day 1 (before administration) for baseline, and post-dosage on Day 3
To assess the effectiveness of the test treatment in altering biomarkers including IL-8 and IgA in nasal wash sample, compared to placebo.
on Day 1 (before administration) for baseline, and post-dosage on Day 3
To assess the safety of the test treatment based on changes in blood parameters, including Serum Creatinine, SGPT, SGOT, Lipid Profile, RBS, Uric acid, and Urinalysis.
on Day 1 (before administration) for baseline, and post-dosage on Day 5
Target Sample Size
Total Sample Size="54" Sample Size from India="54" Final Enrollment numbers achieved (Total)= "0" Final Enrollment numbers achieved (India)="0"
Phase of Trial
N/A
Date of First Enrollment (India)
16/12/2024
Date of Study Completion (India)
Date Missing
Date of First Enrollment (Global)
Date Missing
Date of Study Completion (Global)
Date Missing
Estimated Duration of Trial
Years="0" Months="0" Days="5"
Recruitment Status of Trial (Global)
Not Applicable
Recruitment Status of Trial (India)
Completed
Publication Details
N/A
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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.
·Visit 1:
Screening, evaluations for inclusion.
·Visit 2: Enrolment,
baseline and post-baseline evaluations, treatment commencement.
·Visit 3: Test treatment
usage phase, follow-up evaluations.
·Visit 4 : Test treatment
usage phase, follow-up evaluations.