Study to Assess the Effect of StemAlive® Supplement on the Levels of Stem Cells in Human Volunteers

Study Overview
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Brief Summary
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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.

Official Title
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Assessment of the Effect of StemAlive® Herbal Supplement on the Levels of Circulating Hematopoietic Stem Cells in Human Volunteers

Conditions
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Healthy

Intervention / Treatment
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* Dietary Supplement: StemAlive®
* Dietary Supplement: Placebo (For StemAlive®)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy Male and Female Volunteers Willing to sign Informed Consent Form Exclusion Criteria: Anemia 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: StemAlive®<br>Stem Alive® includes ingredients like green tea, ashwagandha. Dose: 3 capsules twice daily to be taken orally for 14 days. | Dietary Supplement: StemAlive®<br> <br> |
| Placebo Comparator: Placebo<br>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. | Dietary Supplement: Placebo (For StemAlive®)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CD34+ |  | Day 0, Day 1, Day 2, Day 7, Day 12 and Day 14 | 
| CD45+ |  | Day 0, Day 1, Day 2, Day 7, Day 12 and Day 14 | 
| CD133+ |  | Day 0, Day 1, Day 2, Day 7, Day 12 and Day 14 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hematopoietic stem cells, Herbal, Dietary, CD cells, Basic research