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OpenTrials
Completed

NCT Number: NCT00741962

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

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.

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Key information

Conditions

Healthy Adults

Age range

35 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NEMA Research

Naples, Florida, 34108, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • The subject has a history of hypersensitivity to any of the compounds used in the study
  • 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).
  • History of Psychiatric Illness or Chronic Stress or Anxiety
  • Hypertension, cardiovascular disease, or other health concerns that may confound study results
  • Allergy or sensitivity to test product or ingredients
  • Individuals who are cognitively impaired or who are not able to give informed consent
  • Clinically significant or abnormal laboratory result that can confound the study
  • Medication or nutraceutical intake that can interact with the adaptogens or the biomarkers used in the study (to be determined by study physician)
  • Previous participation in a clinical research trial within 30 days prior to randomization
  • The subject has an ongoing abuse of illicit substances, alcohol, or actively smoking marijuana.
  • The subject is actively engaging in the use of Herbal Medicine, Traditional Chinese Medicine, Ancient Indian Medicine, Yoga, or Ayurveda

Treatment and study plan

VR-3 Herbal Blend

Dietary Supplement

This is a liquid blend of various reputed adaptogenic herbs. The dosage will be 2ml of liquid per day.

Placebo

Dietary Supplement

The placebo will be a similar tasting liquid as VR-3 Herbal blend. The dosage will be 2ml of liquid per day.

Primary outcomes

  1. 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 outcomes

  1. Change in acute psychological stress

    Time frame: 10 weeks

  2. Change in chronic stress

    Time frame: 10 weeks

Sponsors and collaborators

Lead sponsor

NEMA Research, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Aug 26, 2008
Registry last updated
May 12, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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