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

NCT ID: NCT01006460

Last Updated: 2010-08-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2010-08-31

Brief Summary

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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

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Conditions

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Depression Stress

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Adapt 232

Group Type EXPERIMENTAL

Rhodiola rosea, L., Eleutherococcus senticosus, Schisandra chinensis

Intervention Type DRUG

3 capsules twice a day

Arctic root group

Group Type EXPERIMENTAL

Rhodiola rosea, L

Intervention Type DRUG

3 Capsules twice a day

Ginseng group

Group Type ACTIVE_COMPARATOR

Panax ginseng

Intervention Type DRUG

3 capsules twice a day

Placebo group

Group Type PLACEBO_COMPARATOR

Placebo - dark brown sugar

Intervention Type DRUG

3 capsules twice a day

Interventions

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Rhodiola rosea, L

3 Capsules twice a day

Intervention Type DRUG

Rhodiola rosea, L., Eleutherococcus senticosus, Schisandra chinensis

3 capsules twice a day

Intervention Type DRUG

Panax ginseng

3 capsules twice a day

Intervention Type DRUG

Placebo - dark brown sugar

3 capsules twice a day

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Frederiksberg University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Frederiksbegg University Hospital

Principal Investigators

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Kaj Winther, Dr

Role: PRINCIPAL_INVESTIGATOR

Clinical Biochemistry department, Frederiksberg Hospital

Locations

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Department of Clinical Biochemistry, Frederikbergs Hospital

Frederiksberg, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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SHR5/DK

Identifier Type: -

Identifier Source: org_study_id

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