HealthyHematoaliveNCT02027467
Study to Assess the Effect of StemAlive® Supplement on the Levels of Stem Cells in Human Volunteers
A study testing StemAlive® in people with Healthy, run by Vedic Lifesciences Pvt. Ltd. at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- StemAlive®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- 1 siteIndia
- Study dates
- Feb 2014to Apr 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy Male and Female Volunteers
- Willing to sign Informed Consent Form
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Healthy
- Being tested
- StemAlive®, Placebo (For StemAlive®)
- Keywords
- Hematopoietic stem cells, Herbal, Dietary, CD cells, Basic research
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StemAlive®Dietary supplement
Placebo (For StemAlive®)Dietary supplement
| Study group | Role | What they receive |
|---|---|---|
| StemAlive® | Experimental | Stem Alive® includes ingredients like green tea, ashwagandha. Dose: 3 capsules twice daily to be taken orally for 14 days. Receives: Dietary Supplement: StemAlive® |
| Placebo | Placebo comparator | 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. Receives: Dietary Supplement: Placebo (For StemAlive®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
CD34+
Measured: Day 0, Day 1, Day 2, Day 7, Day 12 and Day 14
CD45+
Measured: Day 0, Day 1, Day 2, Day 7, Day 12 and Day 14
CD133+
Measured: Day 0, Day 1, Day 2, Day 7, Day 12 and Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2014 (estimated)
- Study startFeb 2014
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vedic Lifesciences Pvt. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Stem Vida International
- Responsible party
- Sponsor
- Investigators
- Sandip Patil, MD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02027467
- Sponsor's protocol ID
- SV/121108/SA/HSC
- Acronym
- Hematoalive
- Status last verified
- May 2014
- First submitted
- 18 Nov 2013
- Last updated
- 6 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Effect of StemAlive® Herbal Supplement on the Levels of Circulating Hematopoietic Stem Cells in Human Volunteers
- ClinicalTrials.gov ID
- NCT02027467
- Acronym / sponsor ID
- Hematoalive / SV/121108/SA/HSC
- Conditions
- Healthy
- Keywords
- Hematopoietic stem cells, Herbal, Dietary, CD cells, Basic research
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Vedic Lifesciences Pvt. Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Stem Vida International
- Study start
- Feb 2014
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 6 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| StemAlive® | Experimental | Dietary Supplement: StemAlive®Stem Alive® includes ingredients like green tea, ashwagandha. Dose: 3 capsules twice daily to be taken orally for 14 days. |
| Placebo | Placebo comparator | Dietary Supplement: Placebo (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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy Male and Female Volunteers
- Willing to sign Informed Consent Form
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| StemAlive® | Dietary supplement | StemAlive® |
| Placebo (For StemAlive®) | Dietary supplement | Placebo |
Primary outcome
CD34+
Time frame: 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
CD133+
Time frame: Day 0, Day 1, Day 2, Day 7, Day 12 and Day 14
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sandip Patil, MD principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing StemAlive® in people with Healthy, run by Vedic Lifesciences Pvt. Ltd. at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CD34+ (time frame: Day 0, Day 1, Day 2, Day 7, Day 12 and Day 14). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2014.