A Study to Evaluate the Efficacy of EQ-778 on Upper Respiratory Tract Health Status in Healthy Adults
- Conditions
- Upper Respiratory Tract Infection
- Interventions
- Other: EQ-778Other: Placebo
- Registration Number
- NCT05835375
- Lead Sponsor
- Vedic Lifesciences Pvt. Ltd.
- Brief 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 374
- 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.
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History of rhinitis medicamentosa, anatomical nasal obstruction or deformity, nasal reconstructive surgery, etc.
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Known sensitivity to the investigational product or any excipients of the drug product.
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Any clinically significant abnormalities of the upper respiratory tract (such as stridor, laryngomalacia, etc)
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Any clinically significant acute or chronic respiratory illness (such as Sinusitis, pharyngitis/tonsillitis, etc)
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Chronic cough of any origin
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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
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Individuals with uncontrolled hypertension on medication and with systolic blood pressure ≥160 and/or diastolic blood pressure ≥100 mm Hg will be excluded.
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Unable to abstain from herbal or dietary supplements for URTI throughout the study period.
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Vaccination against influenza or swine flu within 3 months prior to screening.
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Individuals with COVID infection in the last 30 days
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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.
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History of any significant neurological and psychiatric condition which may affect the participation and inference of the study's end points.
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Participation in other clinical trials in last 30 days prior to screening
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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.
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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.)
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Females who are pregnant/planning to be pregnant/lactating or taking any oral contraceptives.
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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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description EQ-778 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) Placebo 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)
- Primary Outcome Measures
Name Time Method 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. 180 Days
- Secondary Outcome Measures
Name Time Method To evaluate the effect of the IP as compared to placebo 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
Trial Locations
- Locations (13)
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
🇮🇳Dombivli, 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
Umarji Mother and Child Care Hospital, Balewadi Phata, Baner
🇮🇳Pune, Maharashtra, India
Life Care Hospital, Life Care Hospital, Mumbai-Agra Highway, Lekha Nagar
🇮🇳Nashik, Maharashtra, India
Dhanwantri Hospital
🇮🇳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
Tulsi Hospital
🇮🇳Delhi, India
Shatayu, Multispeciality Hospital, Sr no. 275/1, Times Square Building, Bhatewara Nagar, Hinjawadi
🇮🇳Pune, Maharashtra, India
Janta Hospital & Maternity Centre
🇮🇳Varanasi, Uttar Pradesh, India
Dr. Desale's Joint Clinic, 1st Floor, Canada Complex, Above Sagar Sweet, College Road
🇮🇳Nashik, Maharashtra, India