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Completed

NCT Number: 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.

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.

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Key information

Conditions

Upper Respiratory Tract Infection Infections Respiratory Tract Diseases Respiratory Tract Infections

Age range

30 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NovoBliss Research Pvt.Ltd

Ahmedabad, Gujarat, 382481, India

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.
  • 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.

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.
  • 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.

Treatment and study plan

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

Placebo

Other

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

Primary outcomes

  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

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

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

  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.

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

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

Secondary outcomes

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

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

    VAS which indicates 0: No Symptoms and 100: Worst Imaginable Symptoms

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

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

    VAS which indicates 0: No Symptoms and 100: Worst Imaginable Symptoms

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

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

    VAS which indicates 0: No Symptoms and 100: Worst Imaginable Symptoms

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

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

    VAS which indicates 0: No Symptoms and 100: Worst Imaginable Symptoms

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

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

    VAS which indicates 0: No Symptoms and 100: Worst Imaginable Symptoms

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

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

    VAS which indicates 0: No Symptoms and 100: Worst Imaginable Symptoms

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

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

    VAS which indicates 0: No Symptoms and 100: Worst Imaginable Symptoms

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

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

    VAS which indicates 0: No Symptoms and 100: Worst Imaginable Symptoms

  9. 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

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

    NRS Scale Where is 0: No symptom and 10: Worst Imaginable Symptom

  10. 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.

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

    NRS Scale Where is 0: No symptom and 10: Worst Imaginable Symptom

  11. 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.

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

    NRS Scale Where is 0: No symptom and 10: Worst Imaginable Symptom

  12. 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.

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

    NRS Scale Where is 0: No symptom and 10: Worst Imaginable Symptom

  13. 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.

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

    NRS Scale Where is 0: No symptom and 10: Worst Imaginable Symptom

  14. 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.

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

    NRS Scale Where is 0: No symptom and 10: Worst Imaginable Symptom

  15. 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.

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

    NRS Scale Where is 0: No symptom and 10: Worst Imaginable Symptom

  16. 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.

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

    NRS Scale Where is 0: No symptom and 10: Worst Imaginable Symptom

  17. 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.

    Time frame: on Day 1 (before administration) for baseline, and later on Day 2, and Day 3

    nasal mucus weighing kit - pre-weighed tissues and plastic bags with zip-lock seals

  18. To assess the safety of the test treatment

    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 monitoring the occurrence of any adverse events throughout the study period.

  19. To assess the safety of the test treatment by evaluating 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 based on changes in blood parameters, including Serum Creatinine

  20. To assess the safety of the test treatment by evaluating SGPT

    Time frame: on Day 1 (before administration) for baseline, and post-dosage on Day 5

    To assess the safety of the test treatment based on changes in blood parameter, including SGPT

  21. To assess the safety of the test treatment by evaluating SGOT

    Time frame: on Day 1 (before administration) for baseline, and post-dosage on Day 5

    To assess the safety of the test treatment based on changes in blood parameter, including SGOT

  22. To assess the safety of the test treatment by evaluating 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 based on changes in blood parameter, including Lipid Profile

  23. To assess the safety of the test treatment by evaluating RBS

    Time frame: on Day 1 (before administration) for baseline, and post-dosage on Day 5

    To assess the safety of the test treatment based on changes in blood parameter, including RBS

  24. To assess the safety of the test treatment by evaluating 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 based on changes in blood parameter, including Uric acid

  25. To assess the safety of the test treatment by evaluating Urinalysis

    Time frame: on Day 1 (before administration) for baseline, and post-dosage on Day 5

    To assess the safety of the test treatment in terms of change in urine analysis via Lab test

  26. To assess the effectiveness of the test treatment in altering C-reactive protein levels in blood.

    Time frame: on Day 1 (before administration) for baseline, and post-dosage on Day 5

    Effectiveness of the test treatment evaluated in altering C-reactive protein levels in blood.

  27. To assess the effectiveness of the test treatment by evaluating 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 altering biomarkers including IL-8 in nasal wash sample

  28. To assess the effectiveness of the test treatment by evaluating IgA.

    Time frame: on Day 1 (before administration) for baseline, and post-dosage on Day 3

    To assess the effectiveness of the test treatment altering biomarkers including IgA in nasal wash sample, compared to placebo

  29. To evaluate the safety of test treatment by evaluating Haemoglobin

    Time frame: on Day 1 (before administration) for baseline, and post-dosage on Day 3

    To evaluate the safety of test treatment by evaluating change in Haemoglobin lab test

  30. To evaluate the safety of test treatment by evaluating Haematocrit

    Time frame: on Day 1 (before administration) for baseline, and post-dosage on Day 3

    To evaluate the safety of test treatment by evaluating change in Haematocrit using lab test

  31. To evaluate the safety of test treatment by evaluating RBC Count

    Time frame: on Day 1 (before administration) for baseline, and post-dosage on Day 3

    To evaluate the safety of test treatment by evaluating change in RBC Count using lab test

  32. To evaluate the safety of test treatment by evaluating PCV Count

    Time frame: on Day 1 (before administration) for baseline, and post-dosage on Day 3

    To evaluate the safety of test treatment by evaluating change in PCV Count using lab test

  33. To evaluate the safety of test treatment by evaluating RBC Morphology

    Time frame: on Day 1 (before administration) for baseline, and post-dosage on Day 3

    To evaluate the safety of test treatment by evaluating change in RBC Morphology using lab test

  34. To evaluate the safety of test treatment by evaluating mean corpuscular volume (μm3)

    Time frame: on Day 1 (before administration) for baseline, and post-dosage on Day 3

    To evaluate the safety of test treatment by evaluating change in mean corpuscular volume using lab test

  35. To evaluate the safety of test treatment by evaluating 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 change in Mean corpuscular haemoglobin (picograms (pg) per cell)

  36. To evaluate the safety of test treatment by evaluating Mean corpuscular hemoglobin concentration (g/dl)

    Time frame: on Day 1 (before administration) for baseline, and post-dosage on Day 3

    To evaluate the safety of test treatment by evaluating change in Mean corpuscular hemoglobin concentration

  37. To evaluate the safety of test treatment by evaluating 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 change in red cell distribution width

  38. To evaluate the safety of test treatment by evaluating Total White Blood Cell Count (microliter )

    Time frame: on Day 1 (before administration) for baseline, and post-dosage on Day 3

    To evaluate the safety of test treatment by evaluating change in Total WBC Count using lab test

  39. To evaluate the safety of test treatment by evaluating Differential WBC Count

    Time frame: on Day 1 (before administration) for baseline, and post-dosage on Day 3

    To evaluate the safety of test treatment by evaluating change in Differential WBC Count usinglab test

  40. To evaluate the safety of test treatment by evaluating Platelet Count

    Time frame: on Day 1 (before administration) for baseline, and post-dosage on Day 3

    To evaluate the safety of test treatment by evaluating change in Platelet Count using lab test

  41. To evaluate the safety of test treatment by evaluating mean platelet volume

    Time frame: on Day 1 (before administration) for baseline, and post-dosage on Day 3

    To evaluate the safety of test treatment by evaluating change in mean platelet volume using lab test

  42. To evaluate the safety of test treatment by evaluating Procalcitonin

    Time frame: on Day 1 (before administration) for baseline, and post-dosage on Day 3

    To evaluate the safety of test treatment by evaluating change in Procalcitonin using blood test

  43. To evaluate the safety of test treatment by evaluating Platelet 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 change in Platelet distribution width using lab test

Sponsors and collaborators

Lead sponsor

NovoBliss Research Pvt Ltd

Other

Collaborators

  • Ambe Phytoextracts Pvt. Ltd

Registry information

Official study 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.

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 15, 2024
Registry last updated
Feb 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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