A Study to Evaluate the Efficacy of EQ-778 on Upper Respiratory Tract Health Status in Healthy Adults
NCT ID: NCT05835375
Last Updated: 2024-01-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
374 participants
INTERVENTIONAL
2023-08-02
2024-04-26
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
TRIPLE
Study Groups
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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)
EQ-778
1. capsule daily after breakfast (in case of no URTI episode);
2. capsules after breakfast (in case of URTI episode)
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)
Placebo
1. capsule daily after breakfast (in case of no URTI episode);
2. capsules after breakfast (in case of URTI episode)
Interventions
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EQ-778
1. capsule daily after breakfast (in case of no URTI episode);
2. capsules after breakfast (in case of URTI episode)
Placebo
1. capsule daily after breakfast (in case of no URTI episode);
2. capsules after breakfast (in case of URTI episode)
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
50 Years
ALL
Yes
Sponsors
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Vedic Lifesciences Pvt. Ltd.
INDUSTRY
Responsible Party
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Locations
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V S General Hospital, 239, E-Ward, 2nd floor, Trauma Centre, VS General Hospital, Paldi
Ahmedabad, Gujarat, India
Poojan Multispeciality Hospital, Navnidhi Avenue, Shubhash Chowk, Swami Vivekanand Marg, Near, Memnagar
Ahmedabad, Gujarat, India
AIMS Hospital, M.I.D.C., Rd Number 5, Milap Nagar, Dombivli East
Dombivali, Maharashtra, India
Shreepad ENT and Head and Neck Hospital, T-3-5, Third Floor, Hare Krishna Plaza Building, Hirawadi Corner, Opp Panchavati Bus Depo
Nashik, Maharashtra, India
Dr. Desale's Joint Clinic, 1st Floor, Canada Complex, Above Sagar Sweet, College Road
Nashik, Maharashtra, India
Life Care Hospital, Life Care Hospital, Mumbai-Agra Highway, Lekha Nagar
Nashik, Maharashtra, India
Dhanwantri Hospital
Pune, Maharashtra, India
Umarji Mother and Child Care Hospital, Balewadi Phata, Baner
Pune, Maharashtra, India
Shatayu, Multispeciality Hospital, Sr no. 275/1, Times Square Building, Bhatewara Nagar, Hinjawadi
Pune, Maharashtra, India
Gayatri Hospital, 16, 17, 18, Lavdeep Building, Waliv, Vasai East
Vasai, Maharashtra, India
Care n Cure Multispeciality Hospital, Kamdhenu Society, Achole Road, Nallasopara East
Virār, Maharashtra, India
Janta Hospital & Maternity Centre
Varanasi, Uttar Pradesh, India
Tulsi Hospital
Delhi, , India
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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PL/221201/EQ/CCI
Identifier Type: -
Identifier Source: org_study_id
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