Clinical trial NCT01299402: A Study on the Effects of Soulera Herbal Blend Intake on Chronic Stress in Healthy Adults
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Chronic Stress
Lead sponsor: NEMA Research, Inc.
Sponsor class: INDUSTRY
Collaborators: name: LeraPharm Inc.
First posted: 2011-02-18
Enrollment: 64
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Salivary Cortisol Levels
timeFrame: 14 Weeks
Secondary outcomes:
measure: Change in chronic stress
timeFrame: 6 times during 14 weeks
measure: Quality of Life Questionaire
timeFrame: 6 times during 14 weeks
measure: Spot Urine Potassium Test
timeFrame: 6 times during 14 weeks
Other outcomes:
Locations:
city: Naples
country: United States
facility: NEMA Research, Inc.
state: Florida
Study officials:
affiliation: NEMA Research, Inc.
name: Joseph V Pergolizzi, Jr., M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: NEMA Research, Inc.
name: Robert Taylor Jr., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: NEMA Research, Inc.
name: Ismail Shalaby, M.D., Ph.D.
role: STUDY_DIRECTOR
References: