Assessment of the Effect of StemAlive® Herbal Supplement on the Levels of Circulating Hematopoietic Stem Cells in Human Volunteers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- CD45+
研究概览
简要总结
Combination of various herbs is known to promote mobilization of hematopoietic stem cells. Hence the current study has been intended to study the effect of Stem Alive® on mobilization of stem cells. Stem Alive® include ingredients like green tea, ashwagandha, etc which are known to be used as traditional medicine. They are also tested qualitatively in academic and nutritional science research centers throughout the world and which substantially according to those studies stimulate the augmented availability of circulating hematopoietic cells. This study is projected to investigate the mobilization of stem cells on healthy human volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy Male and Female Volunteers
- •Willing to sign Informed Consent Form
排除标准
- •SGOT and Serum Creatinine values twice the upper limit of normal
- •Volunteers who smoke / consume alcohol / take recreational drugs
- •Fever or Flu in the last one week of screening
- •History of Gastric or Duodenal Ulcer
- •Volunteers on vitamins, nutritional or herbal products since last one month
- •Pregnant, Breast feeding and Lactating women
- •Volunteers taking antibiotic, NSAIDS, anti-inflammatory within last 7 days
- •Allergic to ingredients of test product
- •Any co morbid or systemic condition or immunocompromised state making volunteer unfit for participation.
- •Volunteers deemed unfit for the study by the Investigator
研究组 & 干预措施
StemAlive®
Stem Alive® includes ingredients like green tea, ashwagandha. Dose: 3 capsules twice daily to be taken orally for 14 days.
干预措施: StemAlive® (Dietary Supplement)
Placebo
Matching placebo capsules (for StemAlive®) containing polyethylene glycol, rice powder and magnesium stearate. Dose: 3 capsules twice daily to be taken orally for 14 days.
干预措施: Placebo (For StemAlive®) (Dietary Supplement)
结局指标
主要结局
CD45+
时间窗: Day 0, Day 1, Day 2, Day 7, Day 12 and Day 14
CD34+
时间窗: Day 0, Day 1, Day 2, Day 7, Day 12 and Day 14
CD133+
时间窗: Day 0, Day 1, Day 2, Day 7, Day 12 and Day 14
次要结局
未报告次要终点