Middle-aged healthy females above 40 years of age, who for a longer period of time have felt stressed and have experienced reduced quality of life due to demanding daily activities at work and home.
Conditions
Interventions
Product Name: Adapt 232
Pharmaceutical Form: Capsule*
INN or Proposed INN: p-hydroxyphenylethyl-O-ß-D-glucopyranoside
Current Sponsor code: SP.EX-006
Other descriptive name: Rhodiola rosea root dry ex
Sponsors
Swedish Herbal Institute
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Included will be 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Excluded from participating in the study will be subjects: - 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: the objective of this clinical trial is 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+, a combination of three proprietary adaptogenic extracts; Rhodiola rosea extract SRH-5, an extract from berries of Schizandra chinensis, and an extract from roots of Eleutherococcus senticosus, was included into the study in order to evaluate its effect in comparison to the others.;Secondary Objective: ;Primary end point(s): Primary endpoints: Psychological parameters: changes in cognitive functions as measured by - the D2 Test of Attention - selected parts (digit span and digit symbol) of the revised Wechsler Adult Intelligence Scale (WAIS-R) | — |
Countries
Denmark
Outcome results
None listed