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 | Completed

• 1 other identifier: SHR5/DK
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression; Stress

Keywords

Quality of life and subjective well-being in middle aged women

Outcome Measures

Primary Outcomes (1)

• Psychological parameters: changes in cognitive functions as measured by the D2 Test of Attention

  Over a period of 28 days of treatment

Secondary Outcomes (2)

• 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

Study Arms (4)

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

Rhodiola rosea, L DRUG

3 Capsules twice a day

Arctic root group

Rhodiola rosea, L., Eleutherococcus senticosus, Schisandra chinensis DRUG

3 capsules twice a day

Adapt 232

Panax ginseng DRUG

3 capsules twice a day

Ginseng group

Placebo - dark brown sugar DRUG

3 capsules twice a day

Placebo group

Eligibility Criteria

• Age: 40 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Frederiksberg University Hospital: lead

Study Sites (1)

Department of Clinical Biochemistry, Frederikbergs Hospital

Frederiksberg, 2000, Denmark

Location

MeSH Terms

Conditions

Depression

Interventions

Siberian ginseng root; schizandrin; Asian ginseng

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Kaj Winther, Dr

  Clinical Biochemistry department, Frederiksberg Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 1, 2009
• First Posted: November 2, 2009
• Study Start: November 1, 2009
• Primary Completion: July 1, 2010
• Study Completion: August 1, 2010
• Last Updated: August 27, 2010

Record last verified: 2009-11

Locations

DK (1)