Ashwagandha: Effects on Stress, Inflammation and Immune Cell Activation

NCT00817752 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2010-03-18

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Helfgott Research Institute

    collaborator UNKNOWN
  • National University of Natural Medicine

    lead OTHER

Principal Investigators

  • Heather Zwickey, PhD · Helfgott Research Institute at NCNM

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-05-31
Primary Completion
2008-01-31
Completion
2008-02-29

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00817752 on ClinicalTrials.gov