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

Depression Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01006460
• Other study ID #: SHR5/DK
• Status: Completed
• Phase: N/A
• First received: November 1, 2009
• Last updated: August 26, 2010
• Start date: November 2009
• Est. completion date: August 2010

Study information

• Verified date: November 2009
• Source: Frederiksberg University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: August 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Depression
• Stress

Intervention

Drug:
• Rhodiola rosea, L
3 Capsules twice a day
• Rhodiola rosea, L., Eleutherococcus senticosus, Schisandra chinensis
3 capsules twice a day
• Panax ginseng
3 capsules twice a day
• Placebo - dark brown sugar
3 capsules twice a day

Locations

Country	Name	City	State
Denmark	Department of Clinical Biochemistry, Frederikbergs Hospital	Frederiksberg

Sponsors (1)

Lead Sponsor	Collaborator
Frederiksberg University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Psychological parameters: changes in cognitive functions as measured by the D2 Test of Attention		Over a period of 28 days of treatment	Yes
Secondary	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	Yes
Secondary	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	Yes