Chronic StressPhase 1NCT01299402
A Study on the Effects of Soulera Herbal Blend Intake on Chronic Stress in Healthy Adults
A Phase 1 study testing Soulera Herbal Blend in people with Chronic Stress, run by Joseph Pergolizzi, MD at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Stress
- What is being tested?
- Soulera Herbal Blend
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2011to Sep 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- Soulera Herbal Blend, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Soulera Herbal BlendDietary supplement
This a powder blend of various reputed adaptogenic herbs. The dosage will be one 8.6 gram powder sachet daily.
PlaceboDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| Soulera Herbal Blend | Experimental | Not described Receives: Dietary Supplement: Soulera Herbal Blend |
| Placebo Blend | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Salivary Cortisol Levels
Change in salivary cortisol as stress biomarkers for the chronic stress response following Soulera Herbal Blend intake
Measured: 14 Weeks
Secondary outcomes (3)
Change in chronic stress
The State-Trait Anxiety Test will be given to measure the change in both chronic stress and anxiety.(
Measured: 6 times during 14 weeks
Quality of Life Questionaire
A survery to measure your quality of life.
Measured: 6 times during 14 weeks
Spot Urine Potassium Test
A spot urine test will be conducted to determine potassium level. Only the potassium will be measured in the urine.
Measured: 6 times during 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2011 (estimated)
- Study startAug 2011
- Primary completionAug 2012
- Study completionSep 2012
Why it stopped: Financial Reasons
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Joseph Pergolizzi, MD
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- LeraPharm Inc.
- Responsible party
- Sponsor-investigator, Joseph Pergolizzi, MD, NEMA Research, Inc.
- Investigators
- Joseph V Pergolizzi, Jr., M.D., Principal investigator, NEMA Research, Inc.Robert Taylor Jr., Ph.D., Principal investigator, NEMA Research, Inc.Ismail Shalaby, M.D., Ph.D., Study director, NEMA Research, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01299402
- Sponsor's protocol ID
- Adaptogen Study 002
- Status last verified
- Sep 2012
- First submitted
- 15 Feb 2011
- Last updated
- 2 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01299402
- Acronym / sponsor ID
- Adaptogen Study 002
- Conditions
- Chronic Stress
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Financial Reasons
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Joseph Pergolizzi, MDIndustry (pharma, biotech, devices)
- Collaborators
- LeraPharm Inc.
- Study start
- Aug 2011
- Primary completion
- Aug 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 18 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Soulera Herbal Blend | Experimental | Dietary Supplement: Soulera Herbal Blend |
| Placebo Blend | Placebo comparator | Dietary Supplement: Placebo |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Soulera Herbal BlendThis a powder blend of various reputed adaptogenic herbs. The dosage will be one 8.6 gram powder sachet daily. | Dietary supplement | Soulera Herbal Blend |
| PlaceboThe 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. | Dietary supplement | Placebo Blend |
Primary outcome
Salivary Cortisol Levels
Time frame: 14 Weeks
Change in salivary cortisol as stress biomarkers for the chronic stress response following Soulera Herbal Blend intake
3 secondary outcomes
Change in chronic stress
Time frame: 6 times during 14 weeks
Quality of Life Questionaire
Time frame: 6 times during 14 weeks
Spot Urine Potassium Test
Time frame: 6 times during 14 weeks
Results and safety
The study was stopped early (reason given: Financial Reasons). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2012.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joseph V Pergolizzi, Jr., M.D. principal investigator
NEMA Research, Inc.
Robert Taylor Jr., Ph.D. principal investigator
NEMA Research, Inc.
Ismail Shalaby, M.D., Ph.D. study director
NEMA Research, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Soulera Herbal Blend in people with Chronic Stress, run by Joseph Pergolizzi, MD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Financial Reasons). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Salivary Cortisol Levels (time frame: 14 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2012.