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

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ClinicalTrials.gov Identifier: NCT02027467
Recruitment Status : Completed
First Posted : January 6, 2014
Last Update Posted : May 6, 2014
Sponsor:
Collaborator:
Stem Vida International
Information provided by (Responsible Party):
Vedic Lifesciences Pvt. Ltd.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Healthy Dietary Supplement: StemAlive® Dietary Supplement: Placebo (For StemAlive®) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Official Title: Assessment of the Effect of StemAlive® Herbal Supplement on the Levels of Circulating Hematopoietic Stem Cells in Human Volunteers
Study Start Date : February 2014
Actual Primary Completion Date : April 2014
Actual Study Completion Date : April 2014

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



Primary Outcome Measures :
  1. CD34+ [ Time Frame: Day 0, Day 1, Day 2, Day 7, Day 12 and Day 14 ]
  2. CD45+ [ Time Frame: Day 0, Day 1, Day 2, Day 7, Day 12 and Day 14 ]
  3. CD133+ [ Time Frame: Day 0, Day 1, Day 2, Day 7, Day 12 and Day 14 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02027467


Locations
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India
Dhanwantari Clinic
Mumbai, Maharashtra, India, 400072
Sponsors and Collaborators
Vedic Lifesciences Pvt. Ltd.
Stem Vida International
Investigators
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Principal Investigator: Sandip Patil, MD

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Responsible Party: Vedic Lifesciences Pvt. Ltd.
ClinicalTrials.gov Identifier: NCT02027467     History of Changes
Other Study ID Numbers: SV/121108/SA/HSC
First Posted: January 6, 2014    Key Record Dates
Last Update Posted: May 6, 2014
Last Verified: May 2014

Keywords provided by Vedic Lifesciences Pvt. Ltd.:
Hematopoietic stem cells
Herbal
Dietary
CD cells
Basic research