None listed
Conditions
Brief summary
This study will evaluate the effect of MH-PR on a range of biomarkers and cognitive tests associated with age-related decline. Additionally, this study aims to evaluate additional health benefit through measuring change in QOL and blood pressure.
Interventions
MediHerb PhytoRegenex (AUST L 225226) tablets contain extracts of Ginseng (Panax ginseng) 250 mg, Giant Knotweed (Fallopia japonica) 8.0 g, St Mary’s Thistle (Silybum marianum) 4.2 g, Ginkgo (Ginkgo biloba) 1.5 g and Grape Seed (Vitis vinifera) 4.8 g. Participants will take 4 tablets per day (2 tablets morning and 2 tablets evening) orally. The tablets will be supplied in clear brown glass containers with 60 tablets per container. The bottle will be clearly labelled as clinical trial medication
MediHerb PhytoRegenex (AUST L 225226) tablets contain extracts of Ginseng (Panax ginseng) 250 mg, Giant Knotweed (Fallopia japonica) 8.0 g, St Mary’s Thistle (Silybum marianum) 4.2 g, Ginkgo (Ginkgo biloba) 1.5 g and Grape Seed (Vitis vinifera) 4.8 g. Participants will take 4 tablets per day (2 tablets morning and 2 tablets evening) orally. The tablets will be supplied in clear brown glass containers with 60 tablets per container. The bottle will be clearly labelled as clinical trial medication with all necessary clinical trial information including contact details. Trial participation lasts for 84 days. Participants will be provided with sufficient MediHerb PhytoRegenex tablets at baseline (day 0) visit to last for 6 weeks, and an appointment will be made to visit on day 42. Study intervention use will be recorded, and any returned medication will be counted as a measure of compliance. At day 42 participants will be provided with sufficient MediHerb PhytoRegenex tablets at day 42 visit to last for 6 weeks, and an appointment will be made to visit on day 84. Study intervention use will be recorded, and any returned medication will be counted as a measure of compliance. Any participant with less than 60% compliance overall will be excluded from analysis. Follow up phone calls every 2 weeks (at week 2, 4, 8 and 10) will be used to monitor adherence. The last day of taking tablets will be on day 84, the day of the last visit. The last visit can occur (+/- 2) days depending on the availability of the participant.
Sponsors
Integria Healthcare Pty Ltd
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
50 Years to 75 Years
Healthy volunteers
Yes
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
Outcome results
None listed