Clinical trial 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.
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Upper Respiratory Tract Infection
Lead sponsor: NovoBliss Research Pvt Ltd
Sponsor class: OTHER
Collaborators: name: Ambe Phytoextracts Pvt. Ltd
First posted: 2024-11-15
Enrollment: 56
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: Inclusion Criteria:

* 1. 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.

  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.
  1. 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).
  2. 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.

     Exclusion Criteria:
* 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 (e.g., 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 (e.g., systemic corticosteroids, antiviral drugs) within 4 weeks before screening are excluded.

  11. The subject has any condition that, in the investigator's judgment, would compromise the subject's safety or study integrity.

Primary outcomes:
measure: 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
timeFrame: on Day 1 (before administration) for baseline and 6 hours post-dosage, and later on Day 2, Day 3, and Day 5
measure: 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.
timeFrame: on Day 1 (before administration) for baseline and 6 hours post-dosage, and later on Day 2, Day 3, and Day 5
Secondary outcomes:
measure: To assess the effect of the test treatment on symptoms (such as cough), using a Visual Analogue Scale (VAS), compared to placebo.
timeFrame: on Day 1 (before administration) for baseline and 6 hours post-dosage, and later on Day 2, Day 3, and Day 5
measure: To assess the effect of the test treatment on symptoms (such as expectoration), using a Visual Analogue Scale (VAS), compared to placebo.
timeFrame: on Day 1 (before administration) for baseline and 6 hours post-dosage, and later on Day 2, Day 3, and Day 5
measure: To assess the effect of the test treatment on symptoms (such as nasal discharge), using a Visual Analogue Scale (VAS), compared to placebo.
timeFrame: on Day 1 (before administration) for baseline and 6 hours post-dosage, and later on Day 2, Day 3, and Day 5
measure: To assess the effect of the test treatment on symptoms (such as headache), using a Visual Analogue Scale (VAS), compared to placebo.
timeFrame: on Day 1 (before administration) for baseline and 6 hours post-dosage, and later on Day 2, Day 3, and Day 5
measure: To assess the effect of the test treatment on symptoms (such as fever), using a Visual Analogue Scale (VAS), compared to placebo.
timeFrame: on Day 1 (before administration) for baseline and 6 hours post-dosage, and later on Day 2, Day 3, and Day 5
measure: To assess the effect of the test treatment on symptoms (such as sore throat), using a Visual Analogue Scale (VAS), compared to placebo.
timeFrame: on Day 1 (before administration) for baseline and 6 hours post-dosage, and later on Day 2, Day 3, and Day 5
measure: To assess the effect of the test treatment on symptoms (such as earache), using a Visual Analogue Scale (VAS), compared to placebo.
timeFrame: on Day 1 (before administration) for baseline and 6 hours post-dosage, and later on Day 2, Day 3, and Day 5
measure: To assess the effect of the test treatment on symptoms (such as malaise/fatigue), using a Visual Analogue Scale (VAS), compared to placebo.
timeFrame: on Day 1 (before administration) for baseline and 6 hours post-dosage, and later on Day 2, Day 3, and Day 5
measure: 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
timeFrame: on Day 1 (before administration) for baseline and 6 hours post-dosage, and later on Day 2, Day 3, and Day 5
measure: 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.
timeFrame: on Day 1 (before administration) for baseline and 6 hours post-dosage, and later on Day 2, Day 3, and Day 5
measure: 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.
timeFrame: on Day 1 (before administration) for baseline and 6 hours post-dosage, and later on Day 2, Day 3, and Day 5
measure: 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.
timeFrame: on Day 1 (before administration) for baseline and 6 hours post-dosage, and later on Day 2, Day 3, and Day 5
measure: 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.
timeFrame: on Day 1 (before administration) for baseline and 6 hours post-dosage, and later on Day 2, Day 3, and Day 5
measure: 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.
timeFrame: on Day 1 (before administration) for baseline and 6 hours post-dosage, and later on Day 2, Day 3, and Day 5
measure: 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.
timeFrame: on Day 1 (before administration) for baseline and 6 hours post-dosage, and later on Day 2, Day 3, and Day 5
measure: 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.
timeFrame: on Day 1 (before administration) for baseline and 6 hours post-dosage, and later on Day 2, Day 3, and Day 5
measure: 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.
timeFrame: on Day 1 (before administration) for baseline, and later on Day 2, and Day 3
measure: To assess the safety of the test treatment
timeFrame: 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.
measure: To assess the safety of the test treatment by evaluating Serum Creatinine.
timeFrame: on Day 1 (before administration) for baseline, and post-dosage on Day 5
measure: To assess the safety of the test treatment by evaluating SGPT
timeFrame: on Day 1 (before administration) for baseline, and post-dosage on Day 5
measure: To assess the safety of the test treatment by evaluating SGOT
timeFrame: on Day 1 (before administration) for baseline, and post-dosage on Day 5
measure: To assess the safety of the test treatment by evaluating lipid profile
timeFrame: on Day 1 (before administration) for baseline, and post-dosage on Day 5
measure: To assess the safety of the test treatment by evaluating RBS
timeFrame: on Day 1 (before administration) for baseline, and post-dosage on Day 5
measure: To assess the safety of the test treatment by evaluating uric acid
timeFrame: on Day 1 (before administration) for baseline, and post-dosage on Day 5
measure: To assess the safety of the test treatment by evaluating Urinalysis
timeFrame: on Day 1 (before administration) for baseline, and post-dosage on Day 5
measure: To assess the effectiveness of the test treatment in altering C-reactive protein levels in blood.
timeFrame: on Day 1 (before administration) for baseline, and post-dosage on Day 5
measure: To assess the effectiveness of the test treatment by evaluating nasal wash sample.
timeFrame: on Day 1 (before administration) for baseline, and post-dosage on Day 3
measure: To assess the effectiveness of the test treatment by evaluating IgA.
timeFrame: on Day 1 (before administration) for baseline, and post-dosage on Day 3
measure: To evaluate the safety of test treatment by evaluating Haemoglobin
timeFrame: on Day 1 (before administration) for baseline, and post-dosage on Day 3
measure: To evaluate the safety of test treatment by evaluating Haematocrit
timeFrame: on Day 1 (before administration) for baseline, and post-dosage on Day 3
measure: To evaluate the safety of test treatment by evaluating RBC Count
timeFrame: on Day 1 (before administration) for baseline, and post-dosage on Day 3
measure: To evaluate the safety of test treatment by evaluating PCV Count
timeFrame: on Day 1 (before administration) for baseline, and post-dosage on Day 3
measure: To evaluate the safety of test treatment by evaluating RBC Morphology
timeFrame: on Day 1 (before administration) for baseline, and post-dosage on Day 3
measure: To evaluate the safety of test treatment by evaluating mean corpuscular volume (μm3)
timeFrame: on Day 1 (before administration) for baseline, and post-dosage on Day 3
measure: To evaluate the safety of test treatment by evaluating Mean corpuscular haemoglobin (picograms (pg) per cell)
timeFrame: on Day 1 (before administration) for baseline, and post-dosage on Day 3
measure: To evaluate the safety of test treatment by evaluating Mean corpuscular hemoglobin concentration (g/dl)
timeFrame: on Day 1 (before administration) for baseline, and post-dosage on Day 3
measure: To evaluate the safety of test treatment by evaluating red cell distribution width (%)
timeFrame: on Day 1 (before administration) for baseline, and post-dosage on Day 3
measure: To evaluate the safety of test treatment by evaluating Total White Blood Cell Count (microliter )
timeFrame: on Day 1 (before administration) for baseline, and post-dosage on Day 3
measure: To evaluate the safety of test treatment by evaluating Differential WBC Count
timeFrame: on Day 1 (before administration) for baseline, and post-dosage on Day 3
measure: To evaluate the safety of test treatment by evaluating Platelet Count
timeFrame: on Day 1 (before administration) for baseline, and post-dosage on Day 3
measure: To evaluate the safety of test treatment by evaluating mean platelet volume
timeFrame: on Day 1 (before administration) for baseline, and post-dosage on Day 3
measure: To evaluate the safety of test treatment by evaluating Procalcitonin
timeFrame: on Day 1 (before administration) for baseline, and post-dosage on Day 3
measure: To evaluate the safety of test treatment by evaluating Platelet distribution width
timeFrame: on Day 1 (before administration) for baseline, and post-dosage on Day 3
Other outcomes:
Locations:
city: Ahmadabad
country: India
facility: NovoBliss Research Pvt.Ltd
state: Gujarat
Study officials:
affiliation: NovoBliss Research Pvt Ltd
name: Dr. Nayan K Patel
role: PRINCIPAL_INVESTIGATOR
References: