A Study With Arctic Root Compared With the Extract When C... | NCT01006460

Studies
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

NCT01006460

Sponsor

Frederiksberg University Hospital

Status

Completed

Last Update Posted

Aug 27, 2010Estimated

Enrollment

200Estimated

Phase

Not Applicable

Conditions

Depression
Stress

Interventions

Rhodiola rosea, L
Rhodiola rosea, L., Eleutherococcus senticosus, Schisandra chinensis
Panax ginseng
Placebo - dark brown sugar

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Brief Title

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

Status Module

Record Verification Date

Nov 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2009

Primary Completion Date

Jul 2010Actual

Completion Date

Aug 2010Actual

First Submitted Date

Nov 1, 2009

First Submission Date that Met QC Criteria

Nov 1, 2009

First Posted Date

Nov 2, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 26, 2010

Last Update Posted Date

Aug 27, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
Adapt 232	Experimental	Drug: Rhodiola rosea, L., Eleutherococcus senticosus, Schisandra chinensis
Arctic root group	Experimental	Drug: Rhodiola rosea, L
Ginseng group	Active Comparator	Drug: Panax ginseng
Placebo group	Placebo Comparator	Drug: Placebo - dark brown sugar

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Rhodiola rosea, L	Drug	3 Capsules twice a day	Arctic root group
Rhodiola rosea, L., Eleutherococcus senticosus, Schisandra chinensis

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Psychological parameters: changes in cognitive functions as measured by the D2 Test of Attention		Over a period of 28 days of treatment

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kaj Winther, Dr	Clinical Biochemistry department, Frederiksberg Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Clinical Biochemistry, Frederikbergs Hospital		Frederiksberg		2000	Denmark

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

MeSH Terms

ID	Term
D001526	Behavioral Symptoms
D001519	Behavior

ID	Term
C000713177	Siberian ginseng root
C011105	schizandrin
C000713447	Asian ginseng