A Study to Evaluate the Efficacy of EQ-778 on Upper Respiratory Tract Health Status in Healthy Adults

January 30, 2024 updated by: Vedic Lifesciences Pvt. Ltd.

A Randomized, Double-blind, Placebo Controlled Study to Evaluate the Efficacy of EQ-778 on Upper Respiratory Tract Health Status in Healthy Adults

This study is a randomized, double-blind, Placebo Controlled study to evaluate the efficacy of 180 days administration of EQ-778 on upper respiratory tract health status in healthy adults

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
374

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • India
      • Delhi, India, 110094.
        • Recruiting
        • Tulsi Hospital
        • Contact:
    • Gujarat
      • Ahmedabad, Gujarat, India, 380006
        • Recruiting
        • V S General Hospital, 239, E-Ward, 2nd floor, Trauma Centre, VS General Hospital, Paldi
        • Contact:
      • Ahmedabad, Gujarat, India, 380052
        • Recruiting
        • Poojan Multispeciality Hospital, Navnidhi Avenue, Shubhash Chowk, Swami Vivekanand Marg, Near, Memnagar
        • Contact:
    • Maharashtra
      • Dombivli, Maharashtra, India, 421203
        • Recruiting
        • AIMS Hospital, M.I.D.C., Rd Number 5, Milap Nagar, Dombivli East
        • Contact:
      • Nashik, Maharashtra, India, 422003
        • Recruiting
        • Shreepad ENT and Head and Neck Hospital, T-3-5, Third Floor, Hare Krishna Plaza Building, Hirawadi Corner, Opp Panchavati Bus Depo
        • Contact:
      • Nashik, Maharashtra, India, 422005
        • Recruiting
        • Dr. Desale's Joint Clinic, 1st Floor, Canada Complex, Above Sagar Sweet, College Road
        • Contact:
      • Nashik, Maharashtra, India, 422009
        • Recruiting
        • Life Care Hospital, Life Care Hospital, Mumbai-Agra Highway, Lekha Nagar
        • Contact:
      • Pune, Maharashtra, India, 411011
      • Pune, Maharashtra, India, 411045
        • Recruiting
        • Umarji Mother and Child Care Hospital, Balewadi Phata, Baner
        • Contact:
      • Pune, Maharashtra, India, 411057
        • Recruiting
        • Shatayu, Multispeciality Hospital, Sr no. 275/1, Times Square Building, Bhatewara Nagar, Hinjawadi
        • Contact:
      • Vasai, Maharashtra, India, 401208
        • Recruiting
        • Gayatri Hospital, 16, 17, 18, Lavdeep Building, Waliv, Vasai East
        • Contact:
      • Virār, Maharashtra, India, 401209
        • Recruiting
        • Care n Cure Multispeciality Hospital, Kamdhenu Society, Achole Road, Nallasopara East
        • Contact:
    • Uttar Pradesh
      • Varanasi, Uttar Pradesh, India, 221011
        • Recruiting
        • Janta hospital & Maternity Centre
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Male and female individuals ≥ 18 and ≤ 50 years' old with moderate physical activity level as per International Physical Activity Questionnaire - Short Form (IPAQ - SF)
  2. BMI ≥ 18.5 and ≤ 34.9 kg/m2
  3. High susceptibility to URTIs (≥ 3 and ≤ 6 episodes within 12 months)
  4. Commitment to adhere to routine diet and physical activity.
  5. Willing to consume IP or placebo, complete questionnaires, records, etc., associated with the study and to complete all clinical study visits.

Exclusion Criteria:

  1. History of rhinitis medicamentosa, anatomical nasal obstruction or deformity, nasal reconstructive surgery, etc.
  2. Known sensitivity to the investigational product or any excipients of the drug product.
  3. Any clinically significant abnormalities of the upper respiratory tract (such as stridor, laryngomalacia, etc)
  4. Any clinically significant acute or chronic respiratory illness (such as Sinusitis, pharyngitis/tonsillitis, etc)
  5. Chronic cough of any origin
  6. Any individual not willing to follow the abstinence from any home-based remedies for common cold such as steam inhalation, decoctions, vapour rub, etc.
  7. Individuals with uncontrolled type 2 diabetes as assessed by fasting blood glucose ≥ 126 mg/dL
  8. Individuals with uncontrolled hypertension on medication and with systolic blood pressure ≥160 and/or diastolic blood pressure ≥100 mm Hg will be excluded.
  9. Unable to abstain from herbal or dietary supplements for URTI throughout the study period.
  10. Vaccination against influenza or swine flu within 3 months prior to screening.
  11. Individuals with COVID infection in the last 30 days
  12. Those who have taken or should be taking or are taking antibiotics, antivirals, steroids, nasal decongestants, antihistamines, NSAIDS (paracetamol) or other medications that are expected to alleviate cold symptoms within two weeks prior to screening.
  13. History of any significant neurological and psychiatric condition which may affect the participation and inference of the study's end points.
  14. Participation in other clinical trials in last 30 days prior to screening

  15. Individuals with substance abuse problems (within 2 years) defined as:

    1. Use of recreational drugs (such as cocaine, methamphetamine, marijuana, etc.)/Nicotine, tobacco or smoking dependence.
    2. High-risk drinking as defined by consumption of 4 or more alcohol containing beverages on any day or 8 or more alcohol containing beverages per week for women and 5 or more alcohol containing beverages on any day or 15 or more alcohol containing beverages per week for men.
  16. Individuals who have clinically significant following severe illness (i.e., Cardiovascular, endocrine system, immune system, respiratory system, hepatobiliary system, kidney and urinary system, neuropsychiatric, musculoskeletal, inflammatory, blood and tumors, gastrointestinal diseases, etc.)
  17. Females who are pregnant/planning to be pregnant/lactating or taking any oral contraceptives.
  18. Any condition that could, in the opinion of the investigator, preclude the participant's ability to successfully and safely complete the study or that may confound study outcomes.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: EQ-778
  1. capsule to be taken daily after breakfast (in case no URTI episode)
  2. capsules to be taken daily after breakfast (in case of URTI episode)
Other: EQ-778
  1. capsule daily after breakfast (in case of no URTI episode);
  2. capsules after breakfast (in case of URTI episode)
Placebo Comparator: Placebo
  1. capsule to be taken daily after breakfast (in case no URTI episode)
  2. capsules to be taken daily after breakfast (in case of URTI episode)
Other: Placebo
  1. capsule daily after breakfast (in case of no URTI episode);
  2. capsules after breakfast (in case of URTI episode)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
To assess effect of administration of IP on the severity of Upper respiratory tract infections (URTI) symptoms as assessed by area under curve (AUC) for Wisconsin Upper Respiratory Symptom Survey - 21 (WURSS-21) symptom severity score.
Time Frame: 180 Days
180 Days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
To evaluate the effect of the IP as compared to placebo
Time Frame: During episodes of URTI throughout the study
Nasal Viral load as assessed by TRU-PCR analysis
During episodes of URTI throughout the study
To evaluate the effect of the IP as compared to placebo
Time Frame: On every visit (Day 0, Day 30, Day 60, Day 90, Day 120, Day 150, and Day 180)
Change in participants' URTI symptoms severity as compared to the previous day
On every visit (Day 0, Day 30, Day 60, Day 90, Day 120, Day 150, and Day 180)
To evaluate the effect of the IP as compared to placebo
Time Frame: On every visit (Day 0, Day 30, Day 60, Day 90, Day 120, Day 150, and Day 180)
Change in frequency of current URTI episodes rates as compared to the self-reported historical frequency of URTI in previous 6 months before study begins
On every visit (Day 0, Day 30, Day 60, Day 90, Day 120, Day 150, and Day 180)
To evaluate the effect of the IP as compared to placebo
Time Frame: On every visit (Day 0, Day 30, Day 60, Day 90, Day 120, Day 150, and Day 180)
Percentage of population suffering having one or more episode of URTIs during study.
On every visit (Day 0, Day 30, Day 60, Day 90, Day 120, Day 150, and Day 180)
To evaluate the effect of the IP as compared to placebo
Time Frame: On every visit (Day 0, Day 30, Day 60, Day 90, Day 120, Day 150, and Day 180)
The time taken for resolution of the symptoms of the URTIs by eDiary records
On every visit (Day 0, Day 30, Day 60, Day 90, Day 120, Day 150, and Day 180)
To evaluate the effect of the IP as compared to placebo
Time Frame: Day 0, Day 30, Day 60, Day 90, Day 120, Day 150, and Day 180
Change in quality of life using the WURSS-21 questionnaire (in eDiary, as and when the subject gets an episode - recall period: last 24 hours)
Day 0, Day 30, Day 60, Day 90, Day 120, Day 150, and Day 180
To evaluate the effect of the IP as compared to placebo
Time Frame: Day 0 and Day 180
Immunity as assessed by the change in salivary IgA from baseline
Day 0 and Day 180
To evaluate the effect of the IP as compared to placebo
Time Frame: Day 0, Day 30, Day 60, Day 90, Day 120, Day 150 and Day 180
Sleep quality assessed by Pittsburgh Sleep Quality Index
Day 0, Day 30, Day 60, Day 90, Day 120, Day 150 and Day 180
To evaluate the effect of the IP as compared to placebo
Time Frame: Day 0, Day 30, Day 60, Day 90, Day 120, Day 150 and Day 180
Mood as assessed by Visual Analogue Scale (VAS)
Day 0, Day 30, Day 60, Day 90, Day 120, Day 150 and Day 180
To evaluate the effect of the IP as compared to placebo
Time Frame: Day 0, Day 30, Day 60, Day 90, Day 120, Day 150, Day 180 and during each URTI episode
Stress measured by Perceived Stress Scale (PSS)
Day 0, Day 30, Day 60, Day 90, Day 120, Day 150, Day 180 and during each URTI episode
To evaluate the effect of the IP as compared to placebo
Time Frame: Day 0, Day 30, Day 60, Day 90, Day 120, Day 150 and Day 180
General fatigue as assessed by Fatigue Severity Scale (FSS)
Day 0, Day 30, Day 60, Day 90, Day 120, Day 150 and Day 180
To evaluate the effect of the IP as compared to placebo
Time Frame: Day 0, Day 30, Day 60, Day 90, Day 120, Day 150 and Day 180
To assess the effect of the IP on the consumption of rescue medication
Day 0, Day 30, Day 60, Day 90, Day 120, Day 150 and Day 180
To evaluate the effect of the IP as compared to placebo
Time Frame: Day 0, Day 30, Day 60, Day 90, Day 120, Day 150 and Day 180
To assess the impact of the intervention on daily routine activities by a VAS scale
Day 0, Day 30, Day 60, Day 90, Day 120, Day 150 and Day 180
To evaluate the effect of the IP as compared to placebo
Time Frame: On the last day of the URTI episode.
To assess the impact of the IP on mood, stress, fatigue, sleep quality and physical activity as assessed by a VAS scale
On the last day of the URTI episode.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Vedic Lifesciences Pvt. Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 2, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 26, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 26, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 18, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 18, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 28, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 31, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 30, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PL/221201/EQ/CCI

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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