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 study has been completed.
Sponsor:
Information provided by:
Frederiksberg University Hospital
ClinicalTrials.gov Identifier:
NCT01006460
First received: November 1, 2009
Last updated: August 26, 2010
Last verified: November 2009
  Purpose

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.


Condition Intervention
Depression
Stress
Drug: Rhodiola rosea, L
Drug: Rhodiola rosea, L., Eleutherococcus senticosus, Schisandra chinensis
Drug: Panax ginseng
Drug: Placebo - dark brown sugar

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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

Further study details as provided by Frederiksberg University Hospital:

Primary Outcome Measures:
  • Psychological parameters: changes in cognitive functions as measured by the D2 Test of Attention [ Time Frame: Over a period of 28 days of treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 200
Study Start Date: November 2009
Study Completion Date: August 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Adapt 232 Drug: Rhodiola rosea, L., Eleutherococcus senticosus, Schisandra chinensis
3 capsules twice a day
Experimental: Arctic root group Drug: Rhodiola rosea, L
3 Capsules twice a day
Active Comparator: Ginseng group Drug: Panax ginseng
3 capsules twice a day
Placebo Comparator: Placebo group Drug: Placebo - dark brown sugar
3 capsules twice a day

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01006460

Locations
Denmark
Department of Clinical Biochemistry, Frederikbergs Hospital
Frederiksberg, Denmark, 2000
Sponsors and Collaborators
Frederiksberg University Hospital
Investigators
Principal Investigator: Kaj Winther, Dr Clinical Biochemistry department, Frederiksberg Hospital
  More Information

No publications provided

Responsible Party: Kaj Winther Hansen, Frederiksbegg University Hospital
ClinicalTrials.gov Identifier: NCT01006460     History of Changes
Other Study ID Numbers: SHR5/DK
Study First Received: November 1, 2009
Last Updated: August 26, 2010
Health Authority: Denmark: Danish Medicines Agency

Keywords provided by Frederiksberg University Hospital:
Quality of life and subjective well-being in middle aged women

Additional relevant MeSH terms:
Depression
Behavioral Symptoms

ClinicalTrials.gov processed this record on September 18, 2014