Register your interest

Below and on the next page are questions to help discover whether your son may be eligible to participate in the Swinburne University trial.

Parent’s contact information

Parent's first name
Parent's last name
Post code
Phone
Email
Gender of parent
Parent's age

SFI Health Privacy Policy

By completing this online form you agree that your information will be collected and stored by SFI Research for the purposes of assessing your son's potential eligibility for the trial. The information you provide will not be used for any other purpose without your permission.

After completing this form, a Swinburne University representative may call you to ask you a few more questions about your son’s eligibility or ineligibility for the trial.

Does your son have problems with inattention or hyperactivity?

A new study investigating the effects of CDRI08® (a special extract of Bacopa) on children and adolescents with hyperactivity and inattention.

The trial is a 16 week clinical trial taking place in Melbourne investigating whether KeenMind® (containing CDRI 08®, a specific extract of the Ayurvedic herb Bacopa monnieri known for its memory enhancing qualities) may help with the symptoms of inattention and hyperactivity in boys aged between 6 and 14 years.

Over 16 weeks, study participants will be given KeenMind® or a placebo and sit tests measuring their IQ, memory, attention, reaction time, inhibition and behaviour.

Not all people with ADHD have all these symptoms, and everyone can be inattentive, hyperactive or impulsive some of the time, particularly children. But a person with ADHD has symptoms most of the time that can seriously affect their everyday life. They may also be clumsy, unable to sleep, have temper tantrums and mood swings and find it hard to socialise and make friends.

Source: National Institute for Health and Care Excellence

What is Inattention?

Inattention can be simply put as a lack of attention or a reduced attention span. Attention can be defined as the concentration of mental powers upon an object (e.g. a close or careful observing or listening). Everyone is inattentive sometimes. However, for some people inattention becomes a serious condition that leads to significant problems in school or work. Once, inattention was thought of as a problem only experienced by children. Now there is growing evidence that significant inattention affects many people of all ages.

Symptoms

There are many symptoms of inattention, some very obvious and some subtler. The symptoms of inattention include:

  • Making careless mistakes in work or schoolwork
  • Difficulty sustaining attention during a task or when playing
  • Seems to not listen when spoken to directly
  • Doesn’t follow through on instructions and doesn’t finish work or schoolwork
  • Difficulty organising complex tasks
  • Forgetfulness
  • Loses important items
  • Avoids or dislikes activities that require long periods of concentration (e.g. homework)

Some examples of inattention in children include:

  • Trouble keeping focussed during games
  • Avoids school projects (which involve a long periods of concentration)
  • Losing school supplies
  • Difficulties completing household chores
  • Easily distractible

www.myvmc.com/symptoms/inattention/

What is hyperactivity?

Hyperactivity is a common issue faced by many parents and families of children. Not only children can be hyperactive – it is also experienced by some adolescents and even adults. Hyperactivity may be described as an excessive level of activity in a person compared to what is normally expected for their age. Many normal children may at times be hyperactive or restless, but when the hyperactivity begins to affect performance in school, social relationships or behaviour at home, an underlying disorder may be suspected. Hyperactive teenagers or adults may feel internally restless or report needing to stay busy.

Features of hyperactivity

A hyperactive child often:

  • Is "on the go", or acts as if "driven by a motor"
  • Cannot remain seated in situations where sitting quietly is expected (e.g. may often leave his/her seat in class or at dinner)
  • Fidgets in seats, touches everything, or taps things noisily
  • Runs about or climbs excessively in situations where it is inappropriate (e.g. may roam or dash around playing with whatever is in sight)
  • Talks excessively

www.myvmc.com/symptoms/hyperactivity/

KeenMind®, containing CDRI 08®, has been researched for over a decade in Australian clinical trials undertaken by Swinburne University, and has been assisting the memory, recall and concentration of Australians for over a decade.

This trial investigating the effects of KeenMind® on children and adolescents with hyperactivity and inattention is being undertaken by Professor Con Stough at Swinburne University’s Centre For Human Psychopharmacology.

Over the 16 week trial period, parents and their sons are only required to attend 6 trial appointments at Swinburne University. Swinburne University is committed to being as flexible as possible for busy families.

Soho Flordis International are sponsors of the trial and have manufactured and provided the treatments for the study.

Following completion of the trial, parents will be reimbursed up to the value of $50 and receive a three month supply of KeenMind®, with trial participant children each receiving a $50 book voucher.

For more information about the trial or enrolling your son into the trial,
please call (03) 9214 4444 or email jkean@swin.edu.au.

About Bacopa monnieri, a natural plant used in Ayurvedic medicine

Bacopa monnieri (Bacopa) has been mentioned in Indian religious, social and medical histories since 3000 B.C. Its use as a cognitive aid can be traced back to 1500 B.C. Bacopa has been used in Ayurvedic medicine for various indications including memory decline and inflammation.

About KeenMind®

KeenMind®contains a specific extract of Bacopa monnieri (CDRI 08®) that is clinically proven to support memory, concentration and learning retention. It can also be beneficial during times of stress. KeenMind® has been researched for over 40 years by the Indian government’s Central Drug Research Institute and for over ten years in Australian clinical trials undertaken by Professor Stough at Swinburne University’s Centre for Human Psychopharmacology.

KeenMind® Product Leaflet

About Swinburne University’s Centre for Human Psychopharmacology

Swinburne University’s Centre for Human Psychopharmacology has published over 100 publications on clinical trials ranging from vitamins, herbal supplements, pharmaceuticals and illicit drugs across several populations including clinical disorders such as Down’s Syndrome, Major Depression, Generalised Anxiety Disorder, Cognitive Impairment and ADHD as well as in healthy children, adolescents and in the elderly.

Swinburne University Co-Director of The Centre for Human Psychopharmacology Professor Con Stough is the Principal Investigator for this trial, investigating the effects of CDRI08® in young boys between the ages of 6-14 years with symptoms of hyperactivity and inattention.

www.swinburne.edu.au/lss/chp

Healthcare practitioner trial information

The trial will investigate whether KeenMind® (containing CDRI 08®, a specific extract of the herb Bacopa monnieri), may help with the symptoms of inattention and hyperactivity in boys aged between 6 and 14 years of age.

KeenMind®, containing CDRI08®, has been researched for over a decade in Australian clinical trials undertaken by Swinburne University, and has been assisting the memory, recall and concentration of Australians for over a decade.

Study participants will be given KeenMind®, or a placebo, and sit tests measuring their IQ, memory, attention, reaction time, inhibition and behaviour.

The trial is a placebo-controlled, double blind, parallel groups, randomised controlled trial, sponsored by Soho Flordis International.

Parents will receive a report summarising some of their child’s test results.

Study Trial No.: ACTRN12612000827831

Healthcare Practitioner Fact Sheet and Trial Patient Eligibility Checklist

KeenMind® and CDRI 08® clinical papers

Please find below recent clinical research papers on KeenMind® and CDRI 08®

For more information about how participants can enrol into the trial,
call (03) 9214 4444

To assess your son’s eligibility

The information below regarding your son will not be stored and only used to assess trial enrolment eligibility.

  1. Do you wish to enrol you child into the trial investigating effects of CDRI08® on children and adolescents with hyperactivity and inattention?
  2. What is the gender of the child you wish to enrol into the trial?
  3. Is your child aged between 6 and 14 years?
  4. Does your child speak fluent English
  5. Are you and your son able to regularly attend trial appointments at Swinburne University?
  6. Is your child participating in another clinical trial or has participated in another clinical trial within the two months prior to the beginning of the trial?
  7. Does your child have any existing or pre-existing physical or neurological conditions?
  8. Does your child have or had a history of heart disease, high blood pressure or diabetes?
  9. Does your child have any health conditions which may affect their food metabolism? Such as food allergies, kidney disease, liver disease, or any form of gastrointestinal diseases (Irritable Bowel Syndrome, Coeliac disease, peptic ulcers)
  10. Is your child currently on any form of ADHD medication?
  11. How did you hear about this trial?