Authors
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Swedish Herbal Institute -More
Category
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Primary study
Registry of Trials»EU Clinical Trials Register
Year
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2008
INTERVENTION: 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 extract Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 45mg dry extract‐ INN or Proposed INN: 5,6,7,8‐tetrahydro‐1,2,3,10,11, 12‐hexamethoxy‐6,7dimethyldibenzo (a,c)cycklo‐octen‐6‐ol Current Sponsor code: SP.EX‐005 Other descriptive name: schisandra chinesis fruit, dry extract Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 175mg dry extract‐ INN or Proposed INN: 3‐[4‐(1‐O‐ß‐D‐Glucopyranosyl)‐oxy‐3,5‐dimethoxyphenyl)‐2‐propen‐1‐ol,E‐form and 2,6‐Bis[1‐O‐ß‐Glucopyranosyl)‐oxy‐3,5‐dimethoxyphenyl)‐3,7–dioxabicycl Current Sponsor code: SP.EX‐003 Other descriptive name: Eleutherococcus senticosus root dry extraxt, eleutheroside E, eleutheroside B Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 55mg dry extract‐ Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use Product Name: Artcic root Pharmaceutical Form: Capsule, hard INN or Proposed INN: p‐hydroxyphenylethyl‐O‐ß‐D‐glucopyranoside Current Sponsor code: SP.EX.006 Other descriptive name: Rhodiola rosea root dry extract Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 180mg dry extract‐ Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use Product Name: Panax Ginseng Dry Extract/IDB Product Code: 9033921 Pharmaceutical Form: Capsule, hard INN or Proposed INN: 3beta,12beta)‐20‐[(6‐O‐beta‐D‐Glucopyranosyl‐beta‐D‐glucopyranosyl)oxy]‐12‐hydroxydammar‐24‐en‐3‐yl2‐O‐beta‐D‐glucopyranosyl‐beta‐D‐glucopyranoside CAS Number: 41753‐43‐9 Other descriptive name: Panax ginseng root dry extract Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 55mg dry extract‐ Pharmaceu CONDITION: 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. 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 PRIMARY OUTCOME: 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. 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); Secondary Objective:
Epistemonikos ID: 00adb02cdf96d9e838608fb2eaff0eacfa417551
First added on: Aug 21, 2024