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Ashwagandha: Effects on Stress, Inflammation and Immune Cell Activation

Phase 1
18 Years
55 Years
Not Enrolling
Inflammation, Cancer, Autoimmune Diseases

Thank you

Trial Information

Ashwagandha: Effects on Stress, Inflammation and Immune Cell Activation

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

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

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.

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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

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.

Outcome Time Frame:

24 hours and again at 5 days

Safety Issue:


Principal Investigator

Heather Zwickey, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Helfgott Research Institute at NCNM


United States: Institutional Review Board

Study ID:




Start Date:

May 2007

Completion Date:

February 2008

Related Keywords:

  • Inflammation
  • Cancer
  • Autoimmune Diseases
  • stress
  • inflammation
  • natural remedy
  • cytokines
  • interleukin
  • inflammatory conditions
  • auto-immune disorders
  • Autoimmune Diseases
  • Inflammation



Helfgott Research Institute Portland, Oregon  97201