Study to Assess the Effect of StemAlive® Supplement on the Levels of Stem Cells in Human Volunteers
Hematoalive
Assessment of the Effect of StemAlive® Herbal Supplement on the Levels of Circulating Hematopoietic Stem Cells in Human Volunteers
1 other identifier
interventional
23
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable healthy
Started Feb 2014
Shorter than P25 for not_applicable healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 18, 2013
CompletedFirst Posted
Study publicly available on registry
January 6, 2014
CompletedStudy Start
First participant enrolled
February 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2014
CompletedMay 6, 2014
May 1, 2014
2 months
November 18, 2013
May 3, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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
Study Arms (2)
StemAlive®
EXPERIMENTALStem Alive® includes ingredients like green tea, ashwagandha. Dose: 3 capsules twice daily to be taken orally for 14 days.
Placebo
PLACEBO COMPARATORMatching placebo capsules (for StemAlive®) containing polyethylene glycol, rice powder and magnesium stearate. Dose: 3 capsules twice daily to be taken orally for 14 days.
Interventions
Eligibility Criteria
You may qualify if:
- Healthy Male and Female Volunteers
- Willing to sign Informed Consent Form
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Vedic Lifesciences Pvt. Ltd.lead
- Stem Vida Internationalcollaborator
Study Sites (1)
Dhanwantari Clinic
Mumbai, Maharashtra, 400072, India
Study Officials
- PRINCIPAL INVESTIGATOR
Sandip Patil, MD
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 18, 2013
First Posted
January 6, 2014
Study Start
February 1, 2014
Primary Completion
April 1, 2014
Study Completion
April 1, 2014
Last Updated
May 6, 2014
Record last verified: 2014-05