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

F

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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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