A Study With Arctic Root Compared With the Extract When Combined With Schizandra and Russian Root (Adapt 232), Standardized Ginseng Extract and Placebo Regarding Impact on the Level of Energy, Ability to Work Under Stress, Quality of Life and Wellbeing, in Middleaged Women Who Are Still Employed

Study Overview
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Brief Summary
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This is clinical trial to document the efficacy of a proprietary standardized extract of Arctic root in comparison to a standardized commercial extract of ginseng and placebo from an every day consumer perspective to ameliorate mild depression, reduce stress and improve quality of life. A newly developed adaptogenic formulation, Adapt 232, was included into the study in order to evaluate its effect in comparison to the others.

Official Title
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A Randomized, Placebo Controlled, Parallel, Double Blinded Trial With Rhodiola Rosea Extract SHR-5 (Arctic Root) Compared With the Extract When Combined With Schizandra and Russian Root (Adapt 232), Standardized Ginseng Extract and Placebo Regarding Impact on the Level of Energy, Ability to Work Under Stress, Quality of Life and Wellbeing, in Middleaged Women Who Are Still Employed

Conditions
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Depression, Stress

Intervention / Treatment
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* Drug: Rhodiola rosea, L
* Drug: Rhodiola rosea, L., Eleutherococcus senticosus, Schisandra chinensis
* Drug: Panax ginseng
* Drug: Placebo - dark brown sugar


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: healthy females, over 40 years of age, who have stated that they for a longer period of time have felt stressed due to demanding daily activities at work and/or at home. Exclusion Criteria: suffering from any known medical disease, e.g. cardiovascular, joint, and liver or kidney diseases, cancer, or psychiatric disease. with a psychiatric diagnose, using narcotics or suffering from HIV. with known allergy to any of the study medications. misusing euphorizing or pain killing drugs having used any adaptogenic product the last 2 months. having used cortisol or any other corticosteroid products the last 6 months being pregnant or breast-feeding which at the first interview are judged to be not cooperative or not to be able to finalize the study

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Adapt 232<br> | Drug: Rhodiola rosea, L., Eleutherococcus senticosus, Schisandra chinensis<br>* 3 capsules twice a day<br>|
| Experimental: Arctic root group<br> | Drug: Rhodiola rosea, L<br>* 3 Capsules twice a day<br>|
| Active Comparator: Ginseng group<br> | Drug: Panax ginseng<br>* 3 capsules twice a day<br>|
| Placebo Comparator: Placebo group<br> | Drug: Placebo - dark brown sugar<br>* 3 capsules twice a day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Psychological parameters: changes in cognitive functions as measured by the D2 Test of Attention |  | Over a period of 28 days of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depression parameters: changes in depressive state as measured by the using Hamilton Depression Rating Scale (HAM-D) and Bechs Depression Inventory (BDI). |  | over a period of 28 days of treatment | 
| Quality of Life parameters: changes in quality of life as measured by the SF-36 scale, Danish Stress Profile (SP) test and questions regarding various aspects of well-being as formulated in a non-validated VAS scale |  | Over a period of 28 days of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Quality of life and subjective well-being in middle aged women