Ashwagandha: Effects on Stress, Inflammation and Immune Cell Activation
Condition: Inflammation; Cancer; Autoimmune Diseases
MeSH terms: Autoimmune Diseases; Inflammation
Study type: Interventional
Phase: Phase 1

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Ashwagandha
Intervention type(s): Dietary Supplement
Intervention description(s): 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.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: stress; inflammation; natural remedy; cytokines; interleukin; inflammatory conditions; auto-immune disorders