A Study on the Effects of Soulera Herbal Blend Intake on Chronic Stress in Healthy Adults
|ClinicalTrials.gov Identifier: NCT01299402|
Recruitment Status : Terminated (Financial Reasons)
First Posted : February 18, 2011
Last Update Posted : October 2, 2012
|Condition or disease||Intervention/treatment||Phase|
|Chronic Stress||Dietary Supplement: Soulera Herbal Blend Dietary Supplement: Placebo||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||64 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
|Study Start Date :||August 2011|
|Actual Primary Completion Date :||August 2012|
|Actual Study Completion Date :||September 2012|
|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.
- Salivary Cortisol Levels [ Time Frame: 14 Weeks ]Change in salivary cortisol as stress biomarkers for the chronic stress response following Soulera Herbal Blend intake
- Change in chronic stress [ Time Frame: 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 [ Time Frame: 6 times during 14 weeks ]A survery to measure your quality of life.
- Spot Urine Potassium Test [ Time Frame: 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01299402
|United States, Florida|
|NEMA Research, Inc.|
|Naples, Florida, United States, 34108|
|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.|