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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Enrollment
56
Dosage Form: Capsule Route of administration: Oral Frequency: 1 capsule, twice a day after meal for 5 days Dose: 100 mg
Dosage Form: Capsule Route of administration: Oral Frequency: 1 capsule, twice a day after meal for 5 days
NovoBliss Research Pvt.Ltd
Ahmedabad, Gujarat, India
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."
Time frame: 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"
Time frame: 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), using a Visual Analogue Scale (VAS), compared to placebo.
VAS which indicates 0: No Symptoms and 100: Worst Imaginable Symptoms
Time frame: 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.
VAS which indicates 0: No Symptoms and 100: Worst Imaginable Symptoms
Time frame: 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.
VAS which indicates 0: No Symptoms and 100: Worst Imaginable Symptoms
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Time frame: 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.
VAS which indicates 0: No Symptoms and 100: Worst Imaginable Symptoms
Time frame: 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.
VAS which indicates 0: No Symptoms and 100: Worst Imaginable Symptoms
Time frame: 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 sore throat), using a Visual Analogue Scale (VAS), compared to placebo.
VAS which indicates 0: No Symptoms and 100: Worst Imaginable Symptoms
Time frame: 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 earache), using a Visual Analogue Scale (VAS), compared to placebo.
VAS which indicates 0: No Symptoms and 100: Worst Imaginable Symptoms
Time frame: 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 malaise/fatigue), using a Visual Analogue Scale (VAS), compared to placebo.
VAS which indicates 0: No Symptoms and 100: Worst Imaginable Symptoms
Time frame: 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), using the Numeric Rating Scale (NRS) by clinical evaluation for each symptom, compared to placebo
NRS Scale Where is 0: No symptom and 10: Worst Imaginable Symptom
Time frame: 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 the Numeric Rating Scale (NRS) by clinical evaluation for each symptom, compared to placebo.
NRS Scale Where is 0: No symptom and 10: Worst Imaginable Symptom
Time frame: 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 the Numeric Rating Scale (NRS) by clinical evaluation for each symptom, compared to placebo.
NRS Scale Where is 0: No symptom and 10: Worst Imaginable Symptom
Time frame: 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 the Numeric Rating Scale (NRS) by clinical evaluation for each symptom, compared to placebo.
NRS Scale Where is 0: No symptom and 10: Worst Imaginable Symptom
Time frame: 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 the Numeric Rating Scale (NRS) by clinical evaluation for each symptom, compared to placebo.
NRS Scale Where is 0: No symptom and 10: Worst Imaginable Symptom
Time frame: 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 sore throat), using the Numeric Rating Scale (NRS) by clinical evaluation for each symptom, compared to placebo.
NRS Scale Where is 0: No symptom and 10: Worst Imaginable Symptom
Time frame: 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 earache), using the Numeric Rating Scale (NRS) by clinical evaluation for each symptom, compared to placebo.
NRS Scale Where is 0: No symptom and 10: Worst Imaginable Symptom
Time frame: 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 malaise/fatigue), using the Numeric Rating Scale (NRS) by clinical evaluation for each symptom, compared to placebo.
NRS Scale Where is 0: No symptom and 10: Worst Imaginable Symptom
Time frame: 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.
nasal mucus weighing kit - pre-weighed tissues and plastic bags with zip-lock seals
Time frame: on Day 1 (before administration) for baseline, and later on Day 2, and Day 3
To assess the safety of the test treatment
To assess the safety of the test treatment by monitoring the occurrence of any adverse events throughout the study period.
Time frame: To assess the safety of the test treatment by monitoring the occurrence of any adverse events throughout the study period. During the duration of the study of 0 to 5 Days.
To assess the safety of the test treatment by evaluating Serum Creatinine.
To assess the safety of the test treatment based on changes in blood parameters, including Serum Creatinine
Time frame: on Day 1 (before administration) for baseline, and post-dosage on Day 5
To assess the safety of the test treatment by evaluating SGPT
To assess the safety of the test treatment based on changes in blood parameter, including SGPT
Time frame: on Day 1 (before administration) for baseline, and post-dosage on Day 5
To assess the safety of the test treatment by evaluating SGOT
To assess the safety of the test treatment based on changes in blood parameter, including SGOT
Time frame: on Day 1 (before administration) for baseline, and post-dosage on Day 5
To assess the safety of the test treatment by evaluating lipid profile
To assess the safety of the test treatment based on changes in blood parameter, including Lipid Profile
Time frame: on Day 1 (before administration) for baseline, and post-dosage on Day 5
To assess the safety of the test treatment by evaluating RBS
To assess the safety of the test treatment based on changes in blood parameter, including RBS
Time frame: on Day 1 (before administration) for baseline, and post-dosage on Day 5
To assess the safety of the test treatment by evaluating uric acid
To assess the safety of the test treatment based on changes in blood parameter, including Uric acid
Time frame: on Day 1 (before administration) for baseline, and post-dosage on Day 5
To assess the safety of the test treatment by evaluating Urinalysis
To assess the safety of the test treatment in terms of change in urine analysis via Lab test
Time frame: on Day 1 (before administration) for baseline, and post-dosage on Day 5
To assess the effectiveness of the test treatment in altering C-reactive protein levels in blood.
Effectiveness of the test treatment evaluated in altering C-reactive protein levels in blood.
Time frame: on Day 1 (before administration) for baseline, and post-dosage on Day 5
To assess the effectiveness of the test treatment by evaluating nasal wash sample.
To assess the effectiveness of the test treatment altering biomarkers including IL-8 in nasal wash sample
Time frame: on Day 1 (before administration) for baseline, and post-dosage on Day 3
To assess the effectiveness of the test treatment by evaluating IgA.
To assess the effectiveness of the test treatment altering biomarkers including IgA in nasal wash sample, compared to placebo
Time frame: on Day 1 (before administration) for baseline, and post-dosage on Day 3
To evaluate the safety of test treatment by evaluating Haemoglobin
To evaluate the safety of test treatment by evaluating change in Haemoglobin lab test
Time frame: on Day 1 (before administration) for baseline, and post-dosage on Day 3
To evaluate the safety of test treatment by evaluating Haematocrit
To evaluate the safety of test treatment by evaluating change in Haematocrit using lab test
Time frame: on Day 1 (before administration) for baseline, and post-dosage on Day 3
To evaluate the safety of test treatment by evaluating RBC Count
To evaluate the safety of test treatment by evaluating change in RBC Count using lab test
Time frame: on Day 1 (before administration) for baseline, and post-dosage on Day 3
To evaluate the safety of test treatment by evaluating PCV Count
To evaluate the safety of test treatment by evaluating change in PCV Count using lab test
Time frame: on Day 1 (before administration) for baseline, and post-dosage on Day 3
To evaluate the safety of test treatment by evaluating RBC Morphology
To evaluate the safety of test treatment by evaluating change in RBC Morphology using lab test
Time frame: on Day 1 (before administration) for baseline, and post-dosage on Day 3
To evaluate the safety of test treatment by evaluating mean corpuscular volume (μm3)
To evaluate the safety of test treatment by evaluating change in mean corpuscular volume using lab test
Time frame: on Day 1 (before administration) for baseline, and post-dosage on Day 3
To evaluate the safety of test treatment by evaluating Mean corpuscular haemoglobin (picograms (pg) per cell)
To evaluate the safety of test treatment by evaluating change in Mean corpuscular haemoglobin (picograms (pg) per cell)
Time frame: on Day 1 (before administration) for baseline, and post-dosage on Day 3
To evaluate the safety of test treatment by evaluating Mean corpuscular hemoglobin concentration (g/dl)
To evaluate the safety of test treatment by evaluating change in Mean corpuscular hemoglobin concentration
Time frame: on Day 1 (before administration) for baseline, and post-dosage on Day 3
To evaluate the safety of test treatment by evaluating red cell distribution width (%)
To evaluate the safety of test treatment by evaluating change in red cell distribution width
Time frame: on Day 1 (before administration) for baseline, and post-dosage on Day 3
To evaluate the safety of test treatment by evaluating Total White Blood Cell Count (microliter )
To evaluate the safety of test treatment by evaluating change in Total WBC Count using lab test
Time frame: on Day 1 (before administration) for baseline, and post-dosage on Day 3
To evaluate the safety of test treatment by evaluating Differential WBC Count
To evaluate the safety of test treatment by evaluating change in Differential WBC Count usinglab test
Time frame: on Day 1 (before administration) for baseline, and post-dosage on Day 3
To evaluate the safety of test treatment by evaluating Platelet Count
To evaluate the safety of test treatment by evaluating change in Platelet Count using lab test
Time frame: on Day 1 (before administration) for baseline, and post-dosage on Day 3
To evaluate the safety of test treatment by evaluating mean platelet volume
To evaluate the safety of test treatment by evaluating change in mean platelet volume using lab test
Time frame: on Day 1 (before administration) for baseline, and post-dosage on Day 3
To evaluate the safety of test treatment by evaluating Procalcitonin
To evaluate the safety of test treatment by evaluating change in Procalcitonin using blood test
Time frame: on Day 1 (before administration) for baseline, and post-dosage on Day 3
To evaluate the safety of test treatment by evaluating Platelet distribution width
To evaluate the safety of test treatment by evaluating change in Platelet distribution width using lab test
Time frame: on Day 1 (before administration) for baseline, and post-dosage on Day 3