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

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

    • Maharashtra
      • Mumbai, Maharashtra, India, 400072
        • Dhanwantari Clinic

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.

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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