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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00817752 |
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Date of registration:
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02/01/2009 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Ashwagandha: Effects on Stress, Inflammation and Immune Cell Activation
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Scientific title:
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Ashwagandha: Effects on Stress, Inflammation and Immune Cell Activation |
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Date of first enrolment:
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May 2007 |
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Target sample size:
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25 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00817752 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
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Phase:
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Phase 1
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Countries of recruitment
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United States
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Contacts
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Name:
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Heather Zwickey, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Helfgott Research Institute at NCNM |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Healthy adults, not pregnant
Exclusion Criteria:
- Fear or aversion to needles or blood draws.
- Recent infection or immunocompromised.
- Allergy to cow's milk.
- Known herb allergies.
- Aversions or medical contraindications to alcohol.
- Medication contra-indications, such as: benzodiazepines, CNS
depressants,immunosuppressants and thyroid hormone and supplements.
Age minimum:
18 Years
Age maximum:
55 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Inflammation
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Autoimmune Diseases
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Cancer
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Intervention(s)
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Dietary Supplement: Ashwagandha
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Primary Outcome(s)
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The primary endpoint of this study will be to measure immune cell activation, inflammatory cytokines and cortisol levels after administration of the herb.
[Time Frame: 24 hours and again at 5 days]
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Secondary Outcome(s)
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The secondary endpoint of this study will be to measure and correlate stress levels to the use of the herb.
[Time Frame: 24 hours and again at 5 days]
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Secondary ID(s)
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02202007A
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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