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

Not Applicable
Completed
Conditions
Healthy
Interventions
Dietary Supplement: StemAlive®
Dietary Supplement: Placebo (For StemAlive®)
Registration Number
NCT02027467
Lead Sponsor
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
23
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
StemAlive®StemAlive®Stem Alive® includes ingredients like green tea, ashwagandha. Dose: 3 capsules twice daily to be taken orally for 14 days.
PlaceboPlacebo (For StemAlive®)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.
Primary Outcome Measures
NameTimeMethod
CD34+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
CD45+Day 0, Day 1, Day 2, Day 7, Day 12 and Day 14
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Dhanwantari Clinic

🇮🇳

Mumbai, Maharashtra, India

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