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

This study has been terminated.
(Financial Reasons)
Sponsor:
Collaborator:
LeraPharm Inc.
Information provided by (Responsible Party):
Joseph Pergolizzi, MD, NEMA Research, Inc.
ClinicalTrials.gov Identifier:
NCT01299402
First received: February 15, 2011
Last updated: September 30, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention Phase
Chronic Stress
Dietary Supplement: Soulera Herbal Blend
Dietary Supplement: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Pilot Double-Blind Crossover Study on the Effects of Soulera Herbal Blend Intake on Chronic Stress and Its Biomarkers in Healthy Adults

Further study details as provided by NEMA Research, Inc.:

Primary Outcome Measures:
  • Salivary Cortisol Levels [ Time Frame: 14 Weeks ] [ Designated as safety issue: No ]
    Change in salivary cortisol as stress biomarkers for the chronic stress response following Soulera Herbal Blend intake


Secondary Outcome Measures:
  • Change in chronic stress [ Time Frame: 6 times during 14 weeks ] [ Designated as safety issue: No ]
    The State-Trait Anxiety Test will be given to measure the change in both chronic stress and anxiety.(

  • Quality of Life Questionaire [ Time Frame: 6 times during 14 weeks ] [ Designated as safety issue: No ]
    A survery to measure your quality of life.

  • Spot Urine Potassium Test [ Time Frame: 6 times during 14 weeks ] [ Designated as safety issue: Yes ]
    A spot urine test will be conducted to determine potassium level. Only the potassium will be measured in the urine.


Enrollment: 64
Study Start Date: August 2011
Study Completion Date: September 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   21 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01299402

Locations
United States, Florida
NEMA Research, Inc.
Naples, Florida, United States, 34108
Sponsors and Collaborators
Joseph Pergolizzi, MD
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.
  More Information

Additional Information:
No publications provided

Responsible Party: Joseph Pergolizzi, MD, Principal Investigator, NEMA Research, Inc.
ClinicalTrials.gov Identifier: NCT01299402     History of Changes
Other Study ID Numbers: Adaptogen Study 002
Study First Received: February 15, 2011
Last Updated: September 30, 2012
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on October 23, 2014