A Study on the Effects of Soulera Herbal Blend Intake on Chronic Stress in Healthy Adults
NCT ID: NCT01299402
Last Updated: 2012-10-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1
64 participants
INTERVENTIONAL
2011-08-31
2012-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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Soulera Herbal Blend
Soulera Herbal Blend
This a powder blend of various reputed adaptogenic herbs. The dosage will be one 8.6 gram powder sachet daily.
Placebo Blend
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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 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
21 Years
65 Years
ALL
Yes
Sponsors
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LeraPharm Inc.
INDUSTRY
Joseph Pergolizzi, MD
INDUSTRY
Responsible Party
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Joseph Pergolizzi, MD
Principal Investigator
Principal Investigators
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Joseph V Pergolizzi, Jr., M.D.
Role: PRINCIPAL_INVESTIGATOR
NEMA Research, Inc.
Robert Taylor Jr., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
NEMA Research, Inc.
Ismail Shalaby, M.D., Ph.D.
Role: STUDY_DIRECTOR
NEMA Research, Inc.
Locations
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NEMA Research, Inc.
Naples, Florida, United States
Countries
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Related Links
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Related Info
Other Identifiers
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Adaptogen Study 002
Identifier Type: -
Identifier Source: org_study_id