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

Completed · Not applicable · Has a placebo group

Conditions studied: Healthy Adults

In brief

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.

Key facts

Study ID

NCT00741962

Run by

NEMA Research, Inc.

People needed

20

Starts

2008-08-01

Expected to finish

2009-04-01

Last updated by the study team

2009-05-12

Who can join

Age: 35 and older, up to 45. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• NEMA Research — Naples, Florida, United States

Full record on ClinicalTrials.gov

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