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Completed

NCT Number: NCT01006460

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

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.

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Key information

Conditions

Depression Behavior Behavioral Symptoms Stress

Age range

40 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Department of Clinical Biochemistry, Frederikbergs Hospital

Frederiksberg, 2000, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rhodiola rosea, L

Drug

3 Capsules twice a day

Rhodiola rosea, L., Eleutherococcus senticosus, Schisandra chinensis

Drug

3 capsules twice a day

Panax ginseng

Drug

3 capsules twice a day

Placebo - dark brown sugar

Drug

3 capsules twice a day

Primary outcomes

  1. Psychological parameters: changes in cognitive functions as measured by the D2 Test of Attention

    Time frame: Over a period of 28 days of treatment

Secondary outcomes

  1. Depression parameters: changes in depressive state as measured by the using Hamilton Depression Rating Scale (HAM-D) and Bechs Depression Inventory (BDI).

    Time frame: over a period of 28 days of treatment

  2. 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

    Time frame: Over a period of 28 days of treatment

Sponsors and collaborators

Lead sponsor

Frederiksberg University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Nov 2, 2009
Registry last updated
Aug 27, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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