- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02027467
Study to Assess the Effect of StemAlive® Supplement on the Levels of Stem Cells in Human Volunteers (Hematoalive)
May 3, 2014 updated by: Vedic Lifesciences Pvt. Ltd.
Assessment of the Effect of StemAlive® Herbal Supplement on the Levels of Circulating Hematopoietic 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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
23
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Maharashtra
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Mumbai, Maharashtra, India, 400072
- Dhanwantari Clinic
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / 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.
|
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
CD34+
Time Frame: Day 0, Day 1, Day 2, Day 7, Day 12 and Day 14
|
Day 0, Day 1, Day 2, Day 7, Day 12 and Day 14
|
CD45+
Time Frame: Day 0, Day 1, Day 2, Day 7, Day 12 and Day 14
|
Day 0, Day 1, Day 2, Day 7, Day 12 and Day 14
|
CD133+
Time Frame: Day 0, Day 1, Day 2, Day 7, Day 12 and Day 14
|
Day 0, Day 1, Day 2, Day 7, Day 12 and Day 14
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Sandip Patil, MD
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2014
Primary Completion (Actual)
April 1, 2014
Study Completion (Actual)
April 1, 2014
Study Registration Dates
First Submitted
November 18, 2013
First Submitted That Met QC Criteria
January 2, 2014
First Posted (Estimate)
January 6, 2014
Study Record Updates
Last Update Posted (Estimate)
May 6, 2014
Last Update Submitted That Met QC Criteria
May 3, 2014
Last Verified
May 1, 2014
More Information
Terms related to this study
Other Study ID Numbers
- SV/121108/SA/HSC
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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