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Ashwagandha: Effects on Stress, Inflammation and Immune Cell Activation

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ClinicalTrials.gov Identifier: NCT00817752
Recruitment Status : Completed
First Posted : January 6, 2009
Last Update Posted : March 18, 2010
Sponsor:
Collaborator:
Helfgott Research Institute
Information provided by:
National University of Natural Medicine

January 2, 2009
January 6, 2009
March 18, 2010
May 2007
January 2008   (Final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00817752 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Ashwagandha: Effects on Stress, Inflammation and Immune Cell Activation
Ashwagandha: Effects on Stress, Inflammation and Immune Cell Activation
Ayurvedic medicine has been practiced in for more than 2,500 years. Ashwagandha is one of the most widely utilized herbs in the system. It is thought to affect the endocrine, immune, nervous, and cardiopulmonary systems. This study is designed as a preliminary investigation of the effects of Ashwagandha on stress, inflammation, and immune modulation. Participants will take the liquid extract in cow's milk twice a day for five days. The results of initial, one-day, and final blood draws will be compared to determine participant's beginning and ending levels of cortisol, inflammatory cytokines, and immune-cell activation (CD4 T-cells, CD8 T-cells, B cells and natural killer cells). Measurements will be completed using flow cytometry and ELISA assay. The purpose of this study is to determine which effects of Ashwagandha are most suitable for further investigation.

Due to the increased use of alternative medicine, supplements and herbs are consumed more frequently in the treatment of common ailments. This pilot study investigates the immune, anti-inflammatory and anti-stress effects of Ashwagandha in human subjects.

Liquid extract of the herb will be taken followed by milk; this mode of administration will be used as it approximates the traditional administration as well as making self administration easier for participants. Extract will be taken in 3 milliliter quantities 2 times per day, (morning and evening), for five days. Total dosage of 6 milliliters will approximate the higher end of the traditional daily dosage of 6 grams daily of powdered root.

Flow of visit:

25 participants will arrive at the research lab and after being consented, filling out health histories and two stress questionnaires, (POMS and STAI Self-Evaluation), average milk intake questionnaire. The 25 participants will receive blood draws. They will then be administered the herb extract, milk and instructions for taking them.

Subjects will return to the research institute after 24 hours for a second blood draw and then after 5 days for a final blood draw and two more stress questionnaires, (POMS and STAI Self-Evaluation).

Once the blood samples are drawn, they will be refrigerated and processed within 24 hours at the NCNM laboratory. Initially they will be centrifuged to separate the white from the red blood cells using Ficoll separating tubes. Then the white blood cells will be stained using CD69 marker (Cytokine Detection type 69) which assesses cell-surface phenotypic markers in combination with intracellular cytokines, measuring response to activation. It is especially effective for rare-event, antigen-specific events, such as the administration of a specific immune-stimulating herbal tincture. We will also stain with other similar florescent CD markers specific for CD4 T-cells, CD8 T-cells, B-cells, NK cells, and macrophages. These markers will be analyzed using a FACScan flow cytometer, which will count the number of cells that have been activated in each subtype of the immune cell and overall action. Blood will also be analyzed for cortisol levels and inflammatory cytokines, (IL-1, IL-6 and TNF-alpha) using the ELISA assay procedure.

Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
  • Inflammation
  • Cancer
  • Autoimmune Diseases
Dietary Supplement: Ashwagandha
Participants consume 3mL of Ashwagandha for 5 days. Blood work/immune cells (CD4 T-cells, CD8 T-cells, B-cells, NK cells, macrophages, IL-1, IL-6 and TNF-alpha) and psychological assessments (POMS and STAI Self-Evaluation) given at specified time intervals.
Experimental: 1
Receives Ashwagandha herb.
Intervention: Dietary Supplement: Ashwagandha
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
25
Same as current
February 2008
January 2008   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00817752
02202007A
Yes
Not Provided
Not Provided
Heather Zwickey, PhD., Helfgott Research Institute
National University of Natural Medicine
Helfgott Research Institute
Principal Investigator: Heather Zwickey, PhD Helfgott Research Institute at NCNM
National University of Natural Medicine
January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP