Clinical trial 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Stress
Keywords: Quality of life and subjective well-being in middle aged women
Lead sponsor: Frederiksberg University Hospital
Sponsor class: OTHER
First posted: 2009-11-01
Enrollment: 200
Sex: FEMALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Psychological parameters: changes in cognitive functions as measured by the D2 Test of Attention
timeFrame: Over a period of 28 days of treatment
Secondary outcomes:
measure: Depression parameters: changes in depressive state as measured by the using Hamilton Depression Rating Scale (HAM-D) and Bechs Depression Inventory (BDI).
timeFrame: over a period of 28 days of treatment
measure: 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
timeFrame: Over a period of 28 days of treatment
Other outcomes:
Locations:
city: Frederiksberg
country: Denmark
facility: Department of Clinical Biochemistry, Frederikbergs Hospital
Study officials:
affiliation: Clinical Biochemistry department, Frederiksberg Hospital
name: Kaj Winther, Dr
role: PRINCIPAL_INVESTIGATOR
References: