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

NCT01299402 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2012-10-02

No results posted yet for this study

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

Interventions

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.

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.

Sponsors & Collaborators

  • LeraPharm Inc.

    collaborator INDUSTRY

  • Joseph Pergolizzi, MD

    lead INDUSTRY

Principal Investigators

  • Joseph V Pergolizzi, Jr., M.D. · NEMA Research, Inc.

  • Robert Taylor Jr., Ph.D. · NEMA Research, Inc.

  • Ismail Shalaby, M.D., Ph.D. · NEMA Research, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
21 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-08-31
Primary Completion
2012-08-31
Completion
2012-09-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01299402 on ClinicalTrials.gov