A Study on the Effects of Soulera Herbal Blend Intake on Chronic Stress in Healthy Adults
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Soulera Herbal Blend
|
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 Comparator: Placebo Blend
|
Dietary Supplement: 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.
|
Outcome Measures
Primary Outcome Measures
- 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
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Healthy men and women between the ages of 21-65.
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No concerns that would confound the study as determined by study physicians.
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Women must not be pregnant or become pregnant for the duration of the study.
Exclusion Criteria:
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The subject has a history of hypersensitivity to any of the compounds used in the study
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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.
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History of Psychiatric Illness or Chronic Stress or Anxiety
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Hypertension, cardiovascular disease, liver, hypokalemia, or kidney disease or other health concerns that the study physician feels may confound study results
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Individuals who are cognitively impaired or who are not able to give informed consent
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Any routine prescription medication that the study physician feels may cause drug interaction with Soulera or alter the prescription medications' activity
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Previous participation in a clinical research trial within 30 days prior to randomization
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The subject has an ongoing abuse of illicit substances, alcohol, or actively smoking marijuana
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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.
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The subject is a current smoker or uses tobacco products such as chewing tobacco.
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The subject is actively engaging in the use of Herbal Medicine, Traditional Chinese Medicine, Ancient Indian Medicine, Yoga, or Ayurveda
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | NEMA Research, Inc. | Naples | Florida | United States | 34108 |
Sponsors and Collaborators
- Joseph Pergolizzi, MD
- LeraPharm Inc.
Investigators
- Principal Investigator: Joseph V Pergolizzi, Jr., M.D., NEMA Research, Inc.
- Principal Investigator: Robert Taylor Jr., Ph.D., NEMA Research, Inc.
- Study Director: Ismail Shalaby, M.D., Ph.D., NEMA Research, Inc.
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- Adaptogen Study 002