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

Joseph Pergolizzi, MD

Status and phase

Terminated

Phase 1

Conditions

Chronic Stress

Treatments

Dietary Supplement: Placebo

Dietary Supplement: Soulera Herbal Blend

Study type

Interventional

Funder types

Industry

Identifiers

NCT01299402

Adaptogen Study 002

Details and patient eligibility

About

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.

Enrollment

64 patients

Sex

All

Ages

21 to 65 years old

Volunteers

Accepts Healthy Volunteers

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