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

NCT01299402 | Terminated Phase 1

• 1 other identifier: Adaptogen Study 002
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Stress

Outcome Measures

Primary Outcomes (1)

• Salivary Cortisol Levels

  Change in salivary cortisol as stress biomarkers for the chronic stress response following Soulera Herbal Blend intake

  14 Weeks

Secondary Outcomes (3)

• Change in chronic stress

  6 times during 14 weeks

• Quality of Life Questionaire

  6 times during 14 weeks

• Spot Urine Potassium Test

  6 times during 14 weeks

Study Arms (2)

Soulera Herbal Blend

EXPERIMENTAL

Dietary Supplement: Soulera Herbal Blend

Placebo Blend

PLACEBO COMPARATOR

Dietary Supplement: Placebo

Interventions

Soulera Herbal Blend DIETARY_SUPPLEMENT

This a powder blend of various reputed adaptogenic herbs. The dosage will be one 8.6 gram powder sachet daily.

Soulera Herbal Blend

Placebo DIETARY_SUPPLEMENT

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.

Placebo Blend

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Joseph Pergolizzi, MD: lead
• LeraPharm Inc.: collaborator

Study Sites (1)

NEMA Research, Inc.

Naples, Florida, 34108, United States

Location

Related Links

• Related Info

Study Officials

• Joseph V Pergolizzi, Jr., M.D.

  NEMA Research, Inc.

  PRINCIPAL INVESTIGATOR

• Robert Taylor Jr., Ph.D.

  NEMA Research, Inc.

  PRINCIPAL INVESTIGATOR

• Ismail Shalaby, M.D., Ph.D.

  NEMA Research, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 15, 2011
• First Posted: February 18, 2011
• Study Start: August 1, 2011
• Primary Completion: August 1, 2012
• Study Completion: September 1, 2012
• Last Updated: October 2, 2012

Record last verified: 2012-09

Locations

US (1)