Phase
Condition
Respiratory Syncytial Virus (Rsv) Infection
Bronchitis (Pediatric)
Treatment
Placebo
EQ-778
Clinical Study ID
Ages 18-50 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Male and female individuals ≥ 18 and ≤ 50 years' old with moderate physical activitylevel 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., associatedwith the study and to complete all clinical study visits.
Exclusion
Exclusion Criteria:
- History of rhinitis medicamentosa, anatomical nasal obstruction or deformity, nasalreconstructive surgery, etc.
- Known sensitivity to the investigational product or any excipients of the drugproduct.
- Any clinically significant abnormalities of the upper respiratory tract (such asstridor, 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 forcommon cold such as steam inhalation, decoctions, vapour rub, etc.
- Individuals with uncontrolled type 2 diabetes as assessed by fasting blood glucose ≥ 126 mg/dL
- Individuals with uncontrolled hypertension on medication and with systolic bloodpressure ≥160 and/or diastolic blood pressure ≥100 mm Hg will be excluded.
- Unable to abstain from herbal or dietary supplements for URTI throughout the studyperiod.
- 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 othermedications that are expected to alleviate cold symptoms within two weeks prior toscreening.
- History of any significant neurological and psychiatric condition which may affect theparticipation 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 containingbeverages on any day or 8 or more alcohol containing beverages per week for womenand 5 or more alcohol containing beverages on any day or 15 or more alcoholcontaining beverages per week for men.
- Individuals who have clinically significant following severe illness (i.e.,Cardiovascular, endocrine system, immune system, respiratory system, hepatobiliarysystem, 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 oralcontraceptives.
- Any condition that could, in the opinion of the investigator, preclude theparticipant's ability to successfully and safely complete the study or that mayconfound study outcomes.
Study Design
Connect with a study center
Poojan Multispeciality Hospital, Navnidhi Avenue, Shubhash Chowk, Swami Vivekanand Marg, Near, Memnagar
Ahmedabad, Gujarat 380052
IndiaActive - Recruiting
V S General Hospital, 239, E-Ward, 2nd floor, Trauma Centre, VS General Hospital, Paldi
Ahmedabad, Gujarat 380006
IndiaActive - Recruiting
Aman Hospital and Research Centre, 15, Shashwat, Opp. E.S.I Hospital, Gotri Road
Vadodara, Gujarat 390021.
IndiaSite Not Available
AIMS Hospital, M.I.D.C., Rd Number 5, Milap Nagar, Dombivli East
Dombivli, Maharashtra 421203
IndiaActive - Recruiting
Shree Ashirwad Hospital, C/3, Shree Complex, Opp. Mahavir Nagar, Manpada Road, Dombivli East
Dombivli, Maharashtra 421201
IndiaSite Not Available
Dr. Desale's Joint Clinic, 1st Floor, Canada Complex, Above Sagar Sweet, College Road
Nashik, Maharashtra 422005
IndiaActive - Recruiting
Life Care Hospital, Life Care Hospital, Mumbai-Agra Highway, Lekha Nagar
Nashik, Maharashtra 422009
IndiaActive - 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
IndiaActive - Recruiting
Dhanwantri Hospital
Pune, Maharashtra 411011
IndiaActive - Recruiting
Shatayu, Multispeciality Hospital, Sr no. 275/1, Times Square Building, Bhatewara Nagar, Hinjawadi
Pune, Maharashtra 411057
IndiaActive - Recruiting
Umarji Mother and Child Care Hospital, Balewadi Phata, Baner
Pune, Maharashtra 411045
IndiaActive - Recruiting
Gayatri Hospital, 16, 17, 18, Lavdeep Building, Waliv, Vasai East
Vasai, Maharashtra 401208
IndiaActive - Recruiting
Care n Cure Multispeciality Hospital, Kamdhenu Society, Achole Road, Nallasopara East
Virār, Maharashtra 401209
IndiaActive - Recruiting
Janta Hospital & Maternity Centre
Varanasi, Uttar Pradesh 221011
IndiaActive - Recruiting
Tulsi Hospital
Delhi, 110094.
IndiaActive - Recruiting

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