A randomized, multi center, double blinded, placebo-controlled,parallel-group, comparative clinical study to evaluate the immunomodulatory support and overall health benefits ofCUQ1720 and AK-CQAB-0520 among population with Allergic Rhinitis having significant nasal conjunction, sneezing andwheezing (upper respiratory infections).
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- Changes in Allergic Rhinitis (AR) Symptoms
研究概览
简要总结
This is a double blind, randomized (1:1:1), placebo controlled, parallel group, multi-centre, threearm study. Male and female subjects (Age 18-45 years) meeting all inclusion and no exclusioncriteria after signing a written informed consent will be enrolled in the study.After passing the eligibility criteria, subjects will be randomized into 3 treatment arms in 1:1:1 ratioto receive Investigation products CUQ1720 , AK-CQAB-0520 or Placebo twice a day The subjects will undergo laboratory assessments for immune system function assessments. A 7-point visual analogue scale (VAS) will be used for assessing nasal, non-nasal symptom severityand quality of life in the assessment of rhinitis severity.. Health-related quality of life will beassessed by Short Form (SF)-12 questionnaire at the study site.The study is planned to be conducted in 3 visits over a period of 84 days
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Subjects categorized as AR according to international guideline of American Academy of Allergy Asthma and Immunology
- •History of allergic rhinitis (persistent or seasonal) symptoms for at least two consecutive years.
- •No antibiotics use within 1 month prior to entering the study or during the study
- •If female of childbearing age, willing to use an acceptable form of birth control measure, should be stable for past 3 months prior to baseline and throughout the Study
- •Must be willing and able to give informed consent and comply with the study procedures.
排除标准
- •Asthmatic subjects who required long term inhaled or systemic corticosteroids within the previous 30 days
- •Subjects with nasal polyps and chronic respiratory tract infections
- •Subjects having symptoms of viral infection, including COVID-19 infection
- •Subjects with deteriorating health status at the time of enrolment, rapid weight loss, terminal disease, significant chronic disease (e.g., chronic diarrhoea, gastro-intestinal diseases, irritable bowel syndrome)
- •History of Recent blood donation, Immunodeficiency disease (e.g., human immunodeficiency virus [HIV] infection)
- •Concomitant medication/supplement which could affect the study
- •Any contraindication to blood sampling
- •Pregnant and lactating women
- •Subjects allergic to herbal products, nuts or any component of the study product
- •Currently participating or having participated in another clinical trial during the last 3 months prior to the beginning of this study
- •Any additional condition(s) that in the Investigators opinion would warrant exclusion from the study or prevent the subject from completing the study.
结局指标
主要结局
Changes in Allergic Rhinitis (AR) Symptoms
时间窗: Day 0, Day 28, Day 84
次要结局
- Over all health benefits(Day 0, Day 28, Day 84)
- Over all Safety of the test products(Day 0, Day 28, Day 84)