Ashwagandha: Effects on Stress, Inflammation and Immune Cell Activation

This study has been completed.
Sponsor:
Collaborator:
Helfgott Research Institute
Information provided by:
National College of Natural Medicine
ClinicalTrials.gov Identifier:
NCT00817752
First received: January 2, 2009
Last updated: March 17, 2010
Last verified: January 2009
  Purpose

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.


Condition Intervention Phase
Inflammation
Cancer
Autoimmune Diseases
Dietary Supplement: Ashwagandha
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Ashwagandha: Effects on Stress, Inflammation and Immune Cell Activation

Resource links provided by NLM:


Further study details as provided by National College of Natural Medicine:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 25
Study Start Date: May 2007
Study Completion Date: February 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Receives Ashwagandha herb.
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00817752

Locations
United States, Oregon
Helfgott Research Institute
Portland, Oregon, United States, 97201
Sponsors and Collaborators
National College of Natural Medicine
Helfgott Research Institute
Investigators
Principal Investigator: Heather Zwickey, PhD Helfgott Research Institute at NCNM
  More Information

No publications provided

Responsible Party: Heather Zwickey, PhD., Helfgott Research Institute
ClinicalTrials.gov Identifier: NCT00817752     History of Changes
Other Study ID Numbers: 02202007A
Study First Received: January 2, 2009
Last Updated: March 17, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by National College of Natural Medicine:
stress
inflammation
natural remedy
cytokines
interleukin
inflammatory conditions
auto-immune disorders

Additional relevant MeSH terms:
Autoimmune Diseases
Inflammation
Immune System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on August 26, 2014