CTRI/2023/06/054387招募中Unknown
A Randomized, double-blind, Placebo Controlled study to evaluate the efficacy of EQ-778 on upper respiratory tract health status in healthy adults
试验速览
- 阶段
- Unknown
- 状态
- 招募中
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Male and female individuals more than equal to 18 and less than equal to 50 years old with moderate physical activity level as per International Physical Activity Questionnaire Short Form (IPAQ - SF)
- •2. BMI more than equal to 18.5 and less than equal to 34.9 kg per m2
- •3. High susceptibility to URTIs (more than equal to 3 and less than equal to 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.
排除标准
- •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 more than equal to 126 mg/dL
- •8. Individuals with uncontrolled hypertension on medication and with systolic blood pressure more than equal to 160 and/or diastolic blood pressure more than equal to 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
- •a) Use of recreational drugs (such as cocaine, methamphetamine, marijuana, etc.)/Nicotine, tobacco or smoking dependence.
- •b) 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
研究者
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