Ashwagandha: Effects on Stress, Inflammation and Immune Cell Activation

NCT00817752 | Completed Phase 1 DMC

• 1 other identifier: 02202007A
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Inflammation; Cancer; Autoimmune Diseases

Keywords

stress; inflammation; natural remedy; cytokines; interleukin; inflammatory conditions; auto-immune disorders

Outcome Measures

Primary Outcomes (1)

• The primary endpoint of this study will be to measure immune cell activation, inflammatory cytokines and cortisol levels after administration of the herb.

  24 hours and again at 5 days

Secondary Outcomes (1)

• The secondary endpoint of this study will be to measure and correlate stress levels to the use of the herb.

  24 hours and again at 5 days

Study Arms (1)

1

EXPERIMENTAL

Receives Ashwagandha herb.

Dietary Supplement: Ashwagandha

Interventions

Ashwagandha DIETARY_SUPPLEMENT

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.

1

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy adults, not pregnant

You may not qualify if:

• 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.

Sponsors & Collaborators

• National University of Natural Medicine: lead
• Helfgott Research Institute: collaborator

Study Sites (1)

Helfgott Research Institute

Portland, Oregon, 97201, United States

Location

MeSH Terms

Conditions

Inflammation; Neoplasms; Autoimmune Diseases

Interventions

Ashwagandha

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Immune System Diseases

Study Officials

• Heather Zwickey, PhD

  Helfgott Research Institute at NCNM

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 2, 2009
• First Posted: January 6, 2009
• Study Start: May 1, 2007
• Primary Completion: January 1, 2008
• Study Completion: February 1, 2008
• Last Updated: March 18, 2010

Record last verified: 2009-01

Locations

US (1)