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

Chronic Stress Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01299402
• Other study ID #: Adaptogen Study 002
• Status: Terminated
• Phase: Phase 1
• First received: February 15, 2011
• Last updated: September 30, 2012
• Start date: August 2011
• Est. completion date: September 2012

Study information

• Verified date: September 2012
• Source: NEMA Research, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 64
• Est. completion date: September 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Stress

Intervention

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
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.

Locations

Country	Name	City	State
United States	NEMA Research, Inc.	Naples	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Joseph Pergolizzi, MD	LeraPharm Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Salivary Cortisol Levels	Change in salivary cortisol as stress biomarkers for the chronic stress response following Soulera Herbal Blend intake	14 Weeks	No
Secondary	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	No
Secondary	Quality of Life Questionaire	A survery to measure your quality of life.	6 times during 14 weeks	No
Secondary	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	Yes

External Links

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