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Completed

NCT Number: NCT02027467

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

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.

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Key information

Conditions

Healthy

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dhanwantari Clinic

Mumbai, Maharashtra, 400072, India

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

StemAlive®

Dietary Supplement

Placebo (For StemAlive®)

Dietary Supplement

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Vedic Lifesciences Pvt. Ltd.

Industry

Collaborators

  • Stem Vida International

Registry information

Official study title

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

Acronym: Hematoalive

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jan 6, 2014
Registry last updated
May 6, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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