A Study on the Effects of Soulera Herbal Blend Intake on Chronic Stress in Healthy Adults

A Pilot Double-Blind Crossover Study on the Effects of Soulera Herbal Blend Intake on Chronic Stress and Its Biomarkers in Healthy Adults

The purpose of the study was designed to evaluate the efficacy and safety of Soulera herbal mix in powder form and its effects on anxiety and the biomarkers for chronic stress.

Study Overview

• Status: Terminated
• Conditions: Chronic Stress
• Intervention / Treatment: Dietary supplement: Soulera Herbal Blend; Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Naples, Florida, United States, 34108
      • NEMA Research, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy men and women between the ages of 21-65.
• No concerns that would confound the study 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 breast feeding. Note: If the potential subject is a post-menarche female, a urine pregnancy test must be performed within 24 hours prior to study drug administration and confirmed negative in order for the potential subject to eb enrolled.
• History of Psychiatric Illness or Chronic Stress or Anxiety
• Hypertension, cardiovascular disease, liver, hypokalemia, or kidney disease or other health concerns that the study physician feels may confound study results
• Individuals who are cognitively impaired or who are not able to give informed consent
• Any routine prescription medication that the study physician feels may cause drug interaction with Soulera or alter the prescription medications' activity
• 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 uses or has used in the past 30 days any steroid formulation, be it topical like face cream, ocular as in an eye drop, nasal as in a spray, injection or pill.
• The subject is a current smoker or uses tobacco products such as chewing tobacco.
• The subject is actively engaging in the use of Herbal Medicine, Traditional Chinese Medicine, Ancient Indian Medicine, Yoga, or Ayurveda
• The subject is a night-shift worker and therefore presumably has an altered cortisol diurnal rhythm and is also unable to comply with the required cortisol collection times of the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Soulera Herbal Blend	Dietary supplement: Soulera Herbal Blend; This a powder blend of various reputed adaptogenic herbs. The dosage will be one 8.6 gram powder sachet daily.
Placebo Comparator: Placebo Blend	Dietary supplement: Placebo; The placebo will be a similar tasting and looking powder blend as the Soulera Herbal Blend. The dosage will be 8.6 grams per sachet daily.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Salivary Cortisol Levels	Change in salivary cortisol as stress biomarkers for the chronic stress response following Soulera Herbal Blend intake	14 Weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in chronic stress	The State-Trait Anxiety Test will be given to measure the change in both chronic stress and anxiety.(	6 times during 14 weeks
Quality of Life Questionaire	A survery to measure your quality of life.	6 times during 14 weeks
Spot Urine Potassium Test	A spot urine test will be conducted to determine potassium level. Only the potassium will be measured in the urine.	6 times during 14 weeks

Collaborators and Investigators

• Sponsor: Joseph Pergolizzi, MD
• Collaborators: LeraPharm Inc.
• Investigators: Principal Investigator: Joseph V Pergolizzi, Jr., M.D., NEMA Research, Inc.; Principal Investigator: Robert Taylor Jr., Ph.D., NEMA Research, Inc.; Study Director: Ismail Shalaby, M.D., Ph.D., NEMA Research, Inc.

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (Actual): August 1, 2012
• Study Completion (Actual): September 1, 2012

Study Registration Dates

• First Submitted: February 15, 2011
• First Submitted That Met QC Criteria: February 16, 2011
• First Posted (Estimate): February 18, 2011

Study Record Updates

• Last Update Posted (Estimate): October 2, 2012
• Last Update Submitted That Met QC Criteria: September 30, 2012
• Last Verified: September 1, 2012

More Information

Terms related to this study

• Other Study ID Numbers: Adaptogen Study 002