CTRI/2021/07/035206已完成未知
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
- 未知
- 状态
- 已完成
- 入组人数
- 30
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.Healthy male or non-pregnant, non-lactating female human subjects between age of ââ?°Â¥ 30 and ââ?°Â¤ 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 subjectââ?¬•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.
研究者
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