Upper Respiratory Tract InfectionNCT06689995
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.
A study testing Bio-immune Capsule in people with Upper Respiratory Tract Infection, run by NovoBliss Research Pvt Ltd at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Upper Respiratory Tract Infection
- What is being tested?
- Bio-immune Capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteIndia
- Study dates
- 30 Dec 2024to 29 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
- 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.
Who cannot join
- 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.
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the 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.
- Conditions
- Upper Respiratory Tract Infection
- Being tested
- Bio-immune Capsule, Placebo
- Medical subject headings
- Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bio-immune CapsuleOther
Dosage Form: Capsule Route of administration: Oral Frequency: 1 capsule, twice a day after meal for 5 days Dose: 100 mg
PlaceboOther
Dosage Form: Capsule Route of administration: Oral Frequency: 1 capsule, twice a day after meal for 5 days
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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."
Measured: 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"
Measured: 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.
VAS which indicates 0: No Symptoms and 100: Worst Imaginable Symptoms
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: on Day 1 (before administration) for baseline, and post-dosage on Day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2024
- Study start30 Dec 2024
- Primary completion29 Jan 2025
- Study completion29 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Upper Respiratory Tract InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- NovoBliss Research Pvt Ltd
- Sponsor type
- University, hospital or other
- Collaborators
- Ambe Phytoextracts Pvt. Ltd
- Responsible party
- Sponsor
- Investigators
- Dr. Nayan K Patel, Principal investigator, NovoBliss Research Pvt Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06689995
- Sponsor's protocol ID
- NB240047-AP
- Status last verified
- Feb 2025
- First submitted
- 23 Oct 2024
- Last updated
- 28 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Singh SC, Choudhary M, Choudhary K, Singh HP. Evaluating Safety and Efficacy of Bio-Immune (Andrographolide) in Managing URTI Symptoms: A Randomized, Double-Blinded, Placebo-Controlled, Single-Center, Comparative Study. ScientificWorldJournal. 2026;2026(1):e2916630. doi: 10.1155/tswj/2916630.
PubMed 42760788
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT06689995
- Acronym / sponsor ID
- NB240047-AP
- Conditions
- Upper Respiratory Tract Infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- NovoBliss Research Pvt LtdUniversity, hospital or other
- Collaborators
- Ambe Phytoextracts Pvt. Ltd
- Study start
- 30 Dec 2024 (actual)
- Primary completion
- 29 Jan 2025 (actual)
- Study completion
- 29 Jan 2025 (actual)
- First posted
- 15 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bio-immune Capsule | Experimental | Other: Bio-immune CapsuleDosage Form: Capsule Route of administration: Oral Frequency: 1 capsule, twice a day after meal for 5 days Dose: 100 mg |
| Placebo Capsule | Placebo comparator | Other: PlaceboDosage Form: Capsule Route of administration: Oral Frequency: 1 capsule, twice a day after meal for 5 days Dose: 100 mg |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (11 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bio-immune CapsuleDosage Form: Capsule Route of administration: Oral Frequency: 1 capsule, twice a day after meal for 5 days Dose: 100 mg | Other | Bio-immune Capsule |
| PlaceboDosage Form: Capsule Route of administration: Oral Frequency: 1 capsule, twice a day after meal for 5 days | Other | Placebo Capsule |
Primary outcome
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."
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"
43 secondary outcomes
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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 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 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 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 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 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 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 by evaluating Urinalysis
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.
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.
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.
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
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
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
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
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
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)
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)
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)
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 (%)
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 )
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
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
Time frame: on Day 1 (before administration) for baseline, and post-dosage on Day 3
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2025.
- Derived from this study: PubMed 42760788Singh SC, Choudhary M, Choudhary K, Singh HP. Evaluating Safety and Efficacy of Bio-Immune (Andrographolide) in Managing URTI Symptoms: A Randomized, Double-Blinded, Placebo-Controlled, Single-Center, Comparative Study. ScientificWorldJournal. 2026;2026(1):e2916630. doi: 10.1155/tswj/2916630.
- Individual participant dataSharing planned: No
Related trials for Upper Respiratory Tract Infection
RecruitingPhase 1
A Clinical Trial of V175 and V175A in Healthy Adults
Lower Respiratory Tract Infection
Not yet recruiting
Influence of Patient Positioning During Nasal Lavage
Acute Upper Respiratory Tract Infections, Nasal Obstruction
Recruiting
The Impact of MeMed BV® on Management of Patients With Suspected Lower Respiratory Tract Infections (LRTI) in the Emergency Department (ED) and Urgent Care Center (UCC) ("JUPITER" TRIAL)
Lower Respiratory Tract Infection
RecruitingPhase 3
Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia
Respiratory Tract Diseases, Influenza (Pandemic)
Recruiting
Vocxi Breath Analyzer Study in Pediatric Respiratory Infection
Acute Respiratory Illness, Viral Respiratory Infection
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr. Nayan K Patel principal investigator
NovoBliss Research Pvt Ltd
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bio-immune Capsule in people with Upper Respiratory Tract Infection, run by NovoBliss Research Pvt Ltd at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: on Day 1 (before administration) for baseline and 6 hours post-dosage, and later on Day 2, Day 3, and Day 5). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06689995, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2025.