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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:
ClinicalTrials.gov Identifier:
NCT00741962
First Posted: August 26, 2008
Last Update Posted: May 12, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
NEMA Research, Inc.
  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
Intervention Model: Crossover Assignment
Masking: Double (Participant, 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 ]

Secondary Outcome Measures:
  • Change in acute psychological stress [ Time Frame: 10 weeks ]
  • Change in chronic stress [ Time Frame: 10 weeks ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   35 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00741962


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

Responsible Party: Dr. Ismail Shalaby, CEO, NEMA Research, Inc.,
ClinicalTrials.gov Identifier: NCT00741962     History of Changes
Other Study ID Numbers: Adaptogen Study 001
First Submitted: August 25, 2008
First Posted: August 26, 2008
Last Update Posted: May 12, 2009
Last Verified: May 2009