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

Not Applicable

Completed

• Conditions: Depression; Stress
• Interventions: Drug: Rhodiola rosea, L., Eleutherococcus senticosus, Schisandra chinensis; Drug: Rhodiola rosea, L; Drug: Placebo - dark brown sugar; Drug: Panax ginseng

• Registration Number: NCT01006460
• Lead Sponsor: Frederiksberg University Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2009-11
• Study Start: 2009-11
• Study First Submitted: 2009-11-01
• Study First Submitted QC: 2009-11-01
• Study First Posted: 2009-11-01
• Primary Completion: 2010-07
• Study Completion: 2010-08
• Last Update Submitted: 2010-08-26
• Last Update Posted: 2010-08-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 200

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Adapt 232	Rhodiola rosea, L., Eleutherococcus senticosus, Schisandra chinensis	-
Arctic root group	Rhodiola rosea, L	-
Placebo group	Placebo - dark brown sugar	-
Ginseng group	Panax ginseng	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Department of Clinical Biochemistry, Frederikbergs Hospital; 🇩🇰 Frederiksberg, Denmark