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

Phase 1

Terminated

• Conditions: Chronic Stress
• Interventions: Dietary Supplement: Soulera Herbal Blend; Dietary Supplement: Placebo

• Registration Number: NCT01299402
• Lead Sponsor: Joseph Pergolizzi, MD

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-02-15
• Study First Submitted QC: 2011-02-16
• Study First Posted: 2011-02-18
• Study Start: 2011-08
• Primary Completion: 2012-08
• Status Verified: 2012-09
• Study Completion: 2012-09
• Last Update Submitted: 2012-09-30
• Last Update Posted: 2012-10-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 64

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Soulera Herbal Blend	Soulera Herbal Blend	-
Placebo Blend	Placebo	-

Primary Outcome Measures

Name	Time	Method
Salivary Cortisol Levels	14 Weeks	Change in salivary cortisol as stress biomarkers for the chronic stress response following Soulera Herbal Blend intake

Secondary Outcome Measures

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

Trial Locations

Locations (1)

NEMA Research, Inc.; 🇺🇸 Naples, Florida, United States