Upper Respiratory Tract InfectionNCT05835375
A Study to Evaluate the Efficacy of EQ-778 on Upper Respiratory Tract Health Status in Healthy Adults
A study testing EQ-778 in people with Upper Respiratory Tract Infection, run by Vedic Lifesciences Pvt. Ltd. at 13 sites in India.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Upper Respiratory Tract Infection
- What is being tested?
- EQ-778
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 374 participants
- Where
- 13 sitesIndia
- Study dates
- 2 Aug 2023to 26 Apr 2024
- 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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male and female individuals ≥ 18 and ≤ 50 years' old with moderate physical activity level as per International Physical Activity Questionnaire - Short Form (IPAQ - SF)
- BMI ≥ 18.5 and ≤ 34.9 kg/m2
- High susceptibility to URTIs (≥ 3 and ≤ 6 episodes within 12 months)
- Commitment to adhere to routine diet and physical activity.
- Willing to consume IP or placebo, complete questionnaires, records, etc., associated with the study and to complete all clinical study visits.
Who cannot join
- History of rhinitis medicamentosa, anatomical nasal obstruction or deformity, nasal reconstructive surgery, etc.
- Known sensitivity to the investigational product or any excipients of the drug product.
- Any clinically significant abnormalities of the upper respiratory tract (such as stridor, laryngomalacia, etc)
- Any clinically significant acute or chronic respiratory illness (such as Sinusitis, pharyngitis/tonsillitis, etc)
- Chronic cough of any origin
- Any individual not willing to follow the abstinence from any home-based remedies for common cold such as steam inhalation, decoctions, vapour rub, etc.
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- Individuals with uncontrolled type 2 diabetes as assessed by fasting blood glucose ≥ 126 mg/dL
- Individuals with uncontrolled hypertension on medication and with systolic blood pressure ≥160 and/or diastolic blood pressure ≥100 mm Hg will be excluded.
- Unable to abstain from herbal or dietary supplements for URTI throughout the study period.
- Vaccination against influenza or swine flu within 3 months prior to screening.
- Individuals with COVID infection in the last 30 days
- 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.
- History of any significant neurological and psychiatric condition which may affect the participation and inference of the study's end points.
- Participation in other clinical trials in last 30 days prior to screening
- Individuals with substance abuse problems (within 2 years) defined as:
- Use of recreational drugs (such as cocaine, methamphetamine, marijuana, etc.)/Nicotine, tobacco or smoking dependence.
- 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.
- 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.)
- Females who are pregnant/planning to be pregnant/lactating or taking any oral contraceptives.
- 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.
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
India13 sites, 13 recruiting
- Recruiting
V S General Hospital, 239, E-Ward, 2nd floor, Trauma Centre, VS General Hospital, Paldi
Ahmedabad, Gujarat, 380006
Dr. Dhaiwat Shukla, MBBS, MD, 8980024107 ext. +91, dr.dhaiwatshukla89@gmail.com
- Recruiting
Poojan Multispeciality Hospital, Navnidhi Avenue, Shubhash Chowk, Swami Vivekanand Marg, Near, Memnagar
Ahmedabad, Gujarat, 380052
Dr. Ronak Shah, MBBS, MD, 9924656600 ext. +91, poojan.research@gmail.com
- Recruiting
Tulsi Hospital
Delhi, 110094.
Dr. Dipti Gupta, MBBS;MD, 9811678409, drdipti16@gmail.com
- Recruiting
AIMS Hospital, M.I.D.C., Rd Number 5, Milap Nagar, Dombivli East
Dombivali, Maharashtra, 421203
Dr. Sandeep Kadian, MBBS, MD, 9870364574 ext. +91, drsandeepkadian@rediffmail.com
- Recruiting
Shreepad ENT and Head and Neck Hospital, T-3-5, Third Floor, Hare Krishna Plaza Building, Hirawadi Corner, Opp Panchavati Bus Depo
Nashik, Maharashtra, 422003
Dr. Maheshkumar Nikam, MBBS, MS, 8805556996 ext. +91, drmaheshnikam211@gmail.com
- Recruiting
Dr. Desale's Joint Clinic, 1st Floor, Canada Complex, Above Sagar Sweet, College Road
Nashik, Maharashtra, 422005
Dr. Namrata Modi, MBBS, DNB, 7045103821 ext. +91, namratamodi11@gmail.com
- Recruiting
Life Care Hospital, Life Care Hospital, Mumbai-Agra Highway, Lekha Nagar
Nashik, Maharashtra, 422009
Dr. Sandeep Gaidhani, MBBS, MD, 7588606598 ext. +91, drsandeepgaidhani@gmail.com
- Recruiting
Dhanwantri Hospital
Pune, Maharashtra, 411011
Dr. Bharat Jain, MBBS, DNB, 8087448919, dr_bharatjain@rediffmail.com
- Recruiting
Umarji Mother and Child Care Hospital, Balewadi Phata, Baner
Pune, Maharashtra, 411045
Dr. Pramod Umarji, MBBS, MD, 9822307068 ext. +91, pramod.umarji@gmail.com
- Recruiting
Shatayu, Multispeciality Hospital, Sr no. 275/1, Times Square Building, Bhatewara Nagar, Hinjawadi
Pune, Maharashtra, 411057
Dr. Sachin Shivnitwar, 8999285166 ext. +91, drsachinshivnitwar044@gmail.com
- Recruiting
Janta Hospital & Maternity Centre
Varanasi, Uttar Pradesh, 221011
Dr.Manoj Pal, MBBS, PGDGM, 9198677778, manojpalvns@gmail.com
- Recruiting
Gayatri Hospital, 16, 17, 18, Lavdeep Building, Waliv, Vasai East
Vasai, Maharashtra, 401208
Dr. Ashok Jangid, BAMS, MD, 8286163751, ashokbjangid@gmail.com
- Recruiting
Care n Cure Multispeciality Hospital, Kamdhenu Society, Achole Road, Nallasopara East
Virār, Maharashtra, 401209
Dr. Chandrakant Mishra, BAMS, 8888444609 ext. +91, dr.chandrakant89@gmail.com
About this study
Official title: 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
- Conditions
- Upper Respiratory Tract Infection
- Being tested
- EQ-778, 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.
EQ-778Other
- capsule daily after breakfast (in case of no URTI episode);
- capsules after breakfast (in case of URTI episode)
PlaceboOther
- capsule daily after breakfast (in case of no URTI episode);
- capsules after breakfast (in case of URTI episode)
| Study group | Role | What they receive |
|---|---|---|
| EQ-778 | Active comparator | 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) Receives: Other: EQ-778 |
| Placebo | Placebo comparator | 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) Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 180 Days
Secondary outcomes (14)
To evaluate the effect of the IP as compared to placebo
Nasal Viral load as assessed by TRU-PCR analysis
Measured: During episodes of URTI throughout the study
To evaluate the effect of the IP as compared to placebo
Change in participants' URTI symptoms severity as compared to the previous day
Measured: 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
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
Measured: 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
Percentage of population suffering having one or more episode of URTIs during study.
Measured: 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
The time taken for resolution of the symptoms of the URTIs by eDiary records
Measured: 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
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)
Measured: 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
Immunity as assessed by the change in salivary IgA from baseline
Measured: Day 0 and Day 180
To evaluate the effect of the IP as compared to placebo
Sleep quality assessed by Pittsburgh Sleep Quality Index
Measured: 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
Mood as assessed by Visual Analogue Scale (VAS)
Measured: 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
Stress measured by Perceived Stress Scale (PSS)
Measured: 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
General fatigue as assessed by Fatigue Severity Scale (FSS)
Measured: 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
To assess the effect of the IP on the consumption of rescue medication
Measured: 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
To assess the impact of the intervention on daily routine activities by a VAS scale
Measured: 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
To assess the impact of the IP on mood, stress, fatigue, sleep quality and physical activity as assessed by a VAS scale
Measured: On the last day of the URTI episode.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2023
- Study start2 Aug 2023
- Primary completion26 Apr 2024 (estimated)
- Study completion26 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Model description
- Randomized, parallel group, double-blind, placebo-controlled trial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 374 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vedic Lifesciences Pvt. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05835375
- Sponsor's protocol ID
- PL/221201/EQ/CCI
- Status last verified
- Jan 2024
- First submitted
- 18 Apr 2023
- Last updated
- 31 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo Controlled Study to Evaluate the Efficacy of EQ-778 on Upper Respiratory Tract Health Status in Healthy Adults
- ClinicalTrials.gov ID
- NCT05835375
- Acronym / sponsor ID
- PL/221201/EQ/CCI
- Conditions
- Upper Respiratory Tract Infection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 374 participants (estimated)
- Lead sponsor
- Vedic Lifesciences Pvt. Ltd.Industry (pharma, biotech, devices)
- Study start
- 2 Aug 2023 (actual)
- Primary completion
- 26 Apr 2024 (estimated)
- Study completion
- 26 Apr 2024 (estimated)
- First posted
- 28 Apr 2023 (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 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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Randomized, parallel group, double-blind, placebo-controlled trial
| Arm | Type | Receives |
|---|---|---|
| EQ-778 | Active comparator | Other: EQ-7781. 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) |
| Placebo | Placebo comparator | Other: Placebo1. 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) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male and female individuals ≥ 18 and ≤ 50 years' old with moderate physical activity level as per International Physical Activity Questionnaire - Short Form (IPAQ - SF)
- BMI ≥ 18.5 and ≤ 34.9 kg/m2
- High susceptibility to URTIs (≥ 3 and ≤ 6 episodes within 12 months)
- Commitment to adhere to routine diet and physical activity.
- Willing to consume IP or placebo, complete questionnaires, records, etc., associated with the study and to complete all clinical study visits.
Key exclusion criteria (20 listed)
- History of rhinitis medicamentosa, anatomical nasal obstruction or deformity, nasal reconstructive surgery, etc.
- Known sensitivity to the investigational product or any excipients of the drug product.
- Any clinically significant abnormalities of the upper respiratory tract (such as stridor, laryngomalacia, etc)
- Any clinically significant acute or chronic respiratory illness (such as Sinusitis, pharyngitis/tonsillitis, etc)
- Chronic cough of any origin
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 |
|---|---|---|
| EQ-7781. capsule daily after breakfast (in case of no URTI episode); 2. capsules after breakfast (in case of URTI episode) | Other | EQ-778 |
| Placebo1. capsule daily after breakfast (in case of no URTI episode); 2. capsules after breakfast (in case of URTI episode) | Other | Placebo |
Primary outcome
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
14 secondary outcomes
To evaluate the effect of the IP as compared to placebo
Time frame: 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)
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)
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)
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)
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 evaluate the effect of the IP as compared to placebo
Time frame: 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
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 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
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 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 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 evaluate the effect of the IP as compared to placebo
Time frame: On the last day of the URTI episode.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2024.
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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.
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EQ-778 in people with Upper Respiratory Tract Infection, run by Vedic Lifesciences Pvt. Ltd. at 13 sites 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 5 inclusion and 20 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: status not confirmed, as of the sponsor's last update on 31 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dr. Shalini Srivastava, MBBS, MD (42172300 ext. 022, shalini.s@vediclifesciences.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Jan 2024.