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

Frederiksberg University Hospital

Status: Completed

Conditions: Depression; Stress

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

Study type: Interventional

Funder types: Other

Identifiers

NCT01006460

SHR5/DK

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: Female

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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200 participants in 4 patient groups, including a placebo group

Adapt 232

Experimental group

Treatment:

Drug: Rhodiola rosea, L., Eleutherococcus senticosus, Schisandra chinensis

Arctic root group

Experimental group

Treatment:

Drug: Rhodiola rosea, L

Ginseng group

Active Comparator group

Treatment:

Drug: Panax ginseng

Placebo group

Placebo Comparator group

Treatment:

Drug: Placebo - dark brown sugar