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

Study Overview
=================
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.

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

Conditions
-----------------
Healthy Adults

Intervention / Treatment
-----------------
* Dietary Supplement: VR-3 Herbal Blend
* Dietary Supplement: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Dietary Supplement: VR-3 Herbal Blend<br>* This is a liquid blend of various reputed adaptogenic herbs. The dosage will be 2ml of liquid per day.<br>|
| Placebo Comparator: 2<br> | Dietary Supplement: Placebo<br>* The placebo will be a similar tasting liquid as VR-3 Herbal blend. The dosage will be 2ml of liquid per day.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in acute psychological stress |  | 10 weeks | 
| Change in chronic stress |  | 10 weeks |