A prospective, randomized, double-blind, multiple dose, parallel, placebo-controlled, clinical interventional study to evaluate the efficacy and safety of an Immunostimulant supplement on the immunity of healthy human subjects.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- •Mean change from baseline on immunity as determined by laboratory parameters
研究概览
简要总结
A prospective, randomized, double-blind, multipledose, parallel, placebo-controlled, clinical interventional study, proof ofconcept study on healthy human subjects.Single tablet to be taken preferably in the morningafter breakfast for 2 months.Approximately 30 healthy male or non-pregnant,non-lactating female subjects age between ≥ 30 and ≤ 70 years who frequentlysuffer from cold, flu, and fever shall be enrolled into the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 30.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Healthy male or non-pregnant, non-lactating female human subjects between age of ≥ 30 and ≤ 70 years who frequently suffers from cold, flu, and fever.
- •2.Subjects who smoke and willing to abstain from smoking and consuming tobacco throughout the study duration.
- •3.Subjects who consume alcohol and willing to abstain from consuming alcohol throughout the study duration.
- •4.Absence of significant disease or clinically significant abnormal laboratory values on laboratory evaluation at baseline measurement.
- •5.Subjects willing to avoid anti-inflammatory/immunostimulant/ immunosuppressant medications during the study period.
- •6.Female subjects of childbearing potential practicing an approved method of contraception and willing to continue its use throughout the study duration or female subjects of non-childbearing potential.
- •7.Subjects willing to provide written consent.
- •8.Subjects shall be willing and able to understand and comply with the requirements of the study, consume the study IP as instructed, return at the appropriate scheduled visits, comply with therapy prohibitions, and be able to complete the study.
排除标准
- •1.History or evidence of hypersensitivity to any ingredient from the formula or its metabolites.
- •2.Subjects with clinically significant disease(s) or disorder(s) in the opinion of the Investigator may (i) put the subject at risk because of participation in the study (ii) interfere with the study evaluations or (iii) cause concern regarding subject’s ability to participate in the study.
- •3.History of hypo and hyperthyroidism.
- •4.Presence of alarm signs or symptoms, including fever, gastrointestinal bleeding, unintentional weight loss, anemia, dysphagia, or abdominal mass.
- •5.History of milk, gluten allergies, or other known food intolerances and/or any food allergies.
- •6.History of significant systemic diseases, seizures, psychiatric disorders, neurological disorders, depression, or mental illness and allergic rash.
- •7.Subjects taking ace-inhibitors, cholesterol-lowering medications.
- •8.History of difficulty with donating blood or difficulty in the accessibility of veins.
- •9.Receipt of any prescription drugs or over-the-counter drugs (e.g.: cough and cold preparations, antacid preparations and natural products used for therapeutic benefits) within 30 days before screening.
- •10.Current use of an immunostimulant/immunosuppressant supplement.
- •11.Subjects who are pregnant, nursing, or planning a pregnancy within the study participation period.
- •12.Female subjects with positive Urine Pregnancy Test at the screening.
- •13.Subjects who have been treated with any investigational drug or investigational device within 3 months before study entry.
结局指标
主要结局
•Mean change from baseline on immunity as determined by laboratory parameters
时间窗: •Baseline (Visit 1), 4 weeks (Visit 2) and 8 weeks (Visit 3) | •Visit 1 (Baseline), Visit 2 (4 weeks) and Visit 3 (8 weeks) | •Visit 1 (Baseline), Visit 2 (4 weeks) and Visit 3 (8 weeks)
•Mean change from baseline on stress as determined by Perceived Stress Scale
时间窗: •Baseline (Visit 1), 4 weeks (Visit 2) and 8 weeks (Visit 3) | •Visit 1 (Baseline), Visit 2 (4 weeks) and Visit 3 (8 weeks) | •Visit 1 (Baseline), Visit 2 (4 weeks) and Visit 3 (8 weeks)
•Mean change from baseline on sleep as determined by PSQI
时间窗: •Baseline (Visit 1), 4 weeks (Visit 2) and 8 weeks (Visit 3) | •Visit 1 (Baseline), Visit 2 (4 weeks) and Visit 3 (8 weeks) | •Visit 1 (Baseline), Visit 2 (4 weeks) and Visit 3 (8 weeks)
次要结局
未报告次要终点