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A Study on the Effects of VR-3 Herbal Blend Intake on Acute and Chronic Stress in Healthy Adults

This study has been completed.
Sponsor:
Information provided by:
NEMA Research, Inc.
ClinicalTrials.gov Identifier:
NCT00741962
First received: August 25, 2008
Last updated: May 11, 2009
Last verified: May 2009
History of Changes
  Purpose

The purpose of this study is to determine the safety and efficacy of VR-3 Herbal Blend and its effects on acute and chronic stress responses.


Condition Intervention
Healthy Adults
 Dietary Supplement: VR-3 Herbal Blend
Dietary Supplement: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: A Pilot Double-Blind Crossover Study on the Effects of VR-3 Herbal Blend Intake on Acute and Chronic Stress and Their Biomarkers in Healthy Adults

Further study details as provided by NEMA Research, Inc.:

Primary Outcome Measures:
  • Change in salivary alpha-amylase and cortisol as stress biomarkers for the acute and chronic stress response following VR-3 Herbal Blend use [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in acute psychological stress [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
  • Change in chronic stress [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: August 2008
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Dietary Supplement: VR-3 Herbal Blend
This is a liquid blend of various reputed adaptogenic herbs. The dosage will be 2ml of liquid per day.
Placebo Comparator: 2 Dietary Supplement: Placebo
The placebo will be a similar tasting liquid as VR-3 Herbal blend. The dosage will be 2ml of liquid per day.

  Eligibility

Ages Eligible for Study:   35 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Men and women between the ages of 35-45
  2. No health concerns as determined by study physicians
  3. Women must not be pregnant or become pregnant for the duration of the study.

Exclusion Criteria:

  1. The subject has a history of hypersensitivity to any of the compounds used in the study
  2. The subject is pregnant or a lactating female. Note: If the potential subject is a post-menarcheal female, a pregnancy test (urine or serum) must be performed within 24 hours of study drug administration and confirmed negative in order for the potential subject to be enrolled).
  3. History of Psychiatric Illness or Chronic Stress or Anxiety
  4. Hypertension, cardiovascular disease, or other health concerns that may confound study results
  5. Allergy or sensitivity to test product or ingredients
  6. Individuals who are cognitively impaired or who are not able to give informed consent
  7. Clinically significant or abnormal laboratory result that can confound the study
  8. Medication or nutraceutical intake that can interact with the adaptogens or the biomarkers used in the study (to be determined by study physician)
  9. Previous participation in a clinical research trial within 30 days prior to randomization
  10. The subject has an ongoing abuse of illicit substances, alcohol, or actively smoking marijuana.
  11. The subject is actively engaging in the use of Herbal Medicine, Traditional Chinese Medicine, Ancient Indian Medicine, Yoga, or Ayurveda
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00741962

Locations
United States, Florida
NEMA Research
Naples, Florida, United States, 34108
Sponsors and Collaborators
NEMA Research, Inc.
  More Information

No publications provided

Responsible Party: Dr. Ismail Shalaby, CEO, NEMA Research, Inc.,
ClinicalTrials.gov Identifier: NCT00741962     History of Changes
Other Study ID Numbers: Adaptogen Study 001
Study First Received: August 25, 2008
Last Updated: May 11, 2009
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on May 23, 2013