NCT05835375招募中不适用
A Randomized, Double-blind, Placebo Controlled Study to Evaluate the Efficacy of EQ-778 on Upper Respiratory Tract Health Status in Healthy Adults
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 374
- 试验地点
- 26
- 主要终点
- 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.
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
- •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.
结局指标
主要结局
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.
时间窗: 180 Days
次要结局
- To evaluate the effect of the IP as compared to placebo(On the last day of the URTI episode.)
研究者
研究点 (26)
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