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

Healthy Adults Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00741962
• Other study ID #: Adaptogen Study 001
• Status: Completed
• Phase: N/A
• First received: August 25, 2008
• Last updated: May 11, 2009
• Start date: August 2008
• Est. completion date: April 2009

Study information

• Verified date: May 2009
• Source: NEMA Research, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: April 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 35 Years to 45 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Healthy Adults

Intervention

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

Locations

Country	Name	City	State
United States	NEMA Research	Naples	Florida

Sponsors (1)

Lead Sponsor	Collaborator
NEMA Research, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in salivary alpha-amylase and cortisol as stress biomarkers for the acute and chronic stress response following VR-3 Herbal Blend use		10 weeks	No
Secondary	Change in acute psychological stress		10 weeks	No
Secondary	Change in chronic stress		10 weeks	No