CTRI/2020/04/024903已完成不适用
A Prospective Open Label, Single Center, Single-Arm Trial to evaluate the efficacy of AP-Bio®/KalmCold® Capsules in enhancing the immunity and to evaluate its safety in healthy adults
Health Care Company Natural Products1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2020年4月5日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in NK cell count measured using flow cytometry
研究概览
简要总结
Total 30 healthy, adult, human subjects will be enrolled in the study. Single -Arm trial and followed up for one month treatment period . The primary objective to evaluate the efficacy of AP-Bio®/ KalmCold® capsules in enhancing the immunity in healthy adults.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Male or female subjects aged between 18-60 years with BMI 18 to 30 kg/m
- •2.Healthy subjects as determined by: Medical history, Physical examination and Clinical judgment of the Investigator.
- •3.Devoid of any medication during last one month.
- •4.Subject provides written informed consent and comes for regular follow up.
排除标准
- •1.Female subjects who are pregnant, lactating or planning to become pregnant during the study period.
- •2.Subjects receiving influenza vaccination within 3 months before the screening examination.
- •3.Subjects with a clinically significant acute or chronic cardiovascular system, endocrine system, immune system, respiratory system, liver biliary system, kidney and urinary system, neuropsychiatry, musculoskeletal system, inflammatory and hematologic.
- •4.Subjects suffering from different diseases/disorders and/or having any kind of allergy, undergone surgery during last one year.
- •5.Subjects who have received organ transplant, chronic smokers, underlying conditions which might affect immunity.
- •6.Subjects who take a medication or health function food that affects your promotion of immunity within 1 month prior to the screening examination.
- •7.Subjects receiving antipsychotic medication within 3 months prior to the screening examination.
- •8.Subjects who is alcoholic or drug abuse suspected.
- •9.Subjects who have participated in other clinical trials within 3 months prior to the screening examination.
结局指标
主要结局
Change in NK cell count measured using flow cytometry
时间窗: Day -1, Day 3, Day 7 and Day 30
次要结局
- Changes in cytokines(Changes in T cell counts)
研究者
研究点 (1)
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