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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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01006460
Enrollment
200
Registered
2009-11-02
Start date
2009-11-30
Completion date
2010-08-31
Last updated
2010-08-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression, Stress

Keywords

Quality of life and subjective well-being in middle aged women

Brief summary

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.

Interventions

DRUGRhodiola rosea, L

3 Capsules twice a day

DRUGRhodiola rosea, L., Eleutherococcus senticosus, Schisandra chinensis

3 capsules twice a day

DRUGPanax ginseng

3 capsules twice a day

DRUGPlacebo - dark brown sugar

3 capsules twice a day

Sponsors

Frederiksberg University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
40 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Psychological parameters: changes in cognitive functions as measured by the D2 Test of AttentionOver a period of 28 days of treatment

Secondary

MeasureTime 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 scaleOver a period of 28 days of treatment

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026