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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00741962 |
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Date of registration:
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25/08/2008 |
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Primary sponsor: |
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Public title:
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A Study on the Effects of VR-3 Herbal Blend Intake on Acute and Chronic Stress in Healthy Adults
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Scientific title:
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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 |
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Date of first enrolment:
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August 2008 |
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Target sample size:
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20 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00741962 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
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Countries of recruitment
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United States
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Key inclusion & exclusion criteria
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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
Age minimum:
35 Years
Age maximum:
45 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Healthy Adults
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Intervention(s)
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Dietary Supplement: Placebo
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Dietary Supplement: VR-3 Herbal Blend
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Primary Outcome(s)
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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]
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Secondary Outcome(s)
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Change in acute psychological stress
[Time Frame: 10 weeks]
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Change in chronic stress
[Time Frame: 10 weeks]
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Secondary ID(s)
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Adaptogen Study 001
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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