Status:
COMPLETED
A Study on the Effects of VR-3 Herbal Blend Intake on Acute and Chronic Stress in Healthy Adults
Lead Sponsor:
NEMA Research, Inc.
Conditions:
Healthy Adults
Eligibility:
All Genders
35-45 years
Phase:
NA
Brief Summary
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2009
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00741962
Start Date
August 1 2008
End Date
April 1 2009
Last Update
May 12 2009
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
NEMA Research
Naples, Florida, United States, 34108