Evaluation of the effects of a herbal medicine on cognitive function associated with age-related decline in older adults

Not Applicable

Active, not recruiting

• Conditions: Cognitive function; Elderly; Alternative and Complementary Medicine - Other alternative and complementary medicine; Mental Health - Studies of normal psychology, cognitive function and behaviour

• Registration Number: ACTRN12618001850268
• Lead Sponsor: Integria Healthcare Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-11-14
• Last Update Posted: 19 November 2018

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

1) Aged 50-75 years
2) In good health (no serious current illness)
3) If taking any allowed medication(s) or supplement, must be stable for greater than or equal to 2 months

Exclusion Criteria

1) Individuals who are diagnosed with a significant chronic disease, including kidney, liver, neurological disease, autoimmune disease, Diabetes Type 1 or medicated for Type 2, or cancer
2) Hypertension grade 2 or above (>160 systolic and/or >100 diastolic)
3) Individuals taking warfarin or other anti-coagulation medication, antiretroviral, immunosuppressant, anti-psychotic or anti-epileptic medication
4) Currently taking anti-inflammatory medicines (including specific complementary e.g. curcumin and conventional medicines e.g. NSAIDs, corticosteroids, antihistamines, immunosupressants and antibiotics)
5) Currently taking herbal medicines
6) Individuals who have commenced a new conventional or complementary medication in the last 2 months
7) Smokers or currently on nicotine therapy
8) Known allergy to any of the ingredients in the formulation
9) Individuals that have participated in another clinical trial in the last 30 days
10) Current or recent history of stimulant use/abuse

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cognition tests (composite primary outcome): CANTAB core cognition test battery (Paired Associates Learning, Reaction Time, Spatial Working Memory)[Screening visit (day -5) – familiarize CANTAB cognition software<br>CANTAB cognition tests conducted at baseline (day 0); day 42 and day 84 (primary endpoint)]

Secondary Outcome Measures

Name	Time	Method
Biomarkers (composite secondary outcome): Serum assays will be performed for all biomarkers.<br>Interleukin-6 (IL-6), Tumor necrosis factor alpha (TNF-a), High sensitivity C-reactive protein (hs-CRP), Glutathione (GSH), Brain derived neurotrophic factor (BDNF), Dehydroepiandrosterone sulphate (DHEAS), Glycosylated haemoglobin (HbA1c), Fasting blood glucose, Insulin, IGF-1, 8-iso prostaglandin F2a, 8-hydroxy-2' -deoxyguanosine (8-OHdG) <br>[Baseline (day 0) and day 84 ];Quality of Life using Short form -12 (SF-12)[Baseline (day 0); day 42 and day 84];Blood pressure measured using a digital blood pressure monitor.[Baseline (day 0); day 42 and day 84]