Next Article in Journal
Protective Effect of Vanillic Acid against Hyperinsulinemia, Hyperglycemia and Hyperlipidemia via Alleviating Hepatic Insulin Resistance and Inflammation in High-Fat Diet (HFD)-Fed Rats
Previous Article in Journal
Gestational Vitamin 25(OH)D Status as a Risk Factor for Receptive Language Development: A 24-Month, Longitudinal, Observational Study
Article Menu

Export Article

Open AccessCommunication
Nutrients 2015, 7(12), 9931-9945; doi:10.3390/nu7125507

A Randomized Controlled Trial Investigating the Effects of a Special Extract of Bacopa monnieri (CDRI 08) on Hyperactivity and Inattention in Male Children and Adolescents: BACHI Study Protocol (ANZCTRN12612000827831)

1
Centre for Human Psychopharmacology, Swinburne University of Technology, Hawthorn 3122, Australia
2
Swinburne Babylab, Swinburne University of Technology, Hawthorn 3122, Australia
3
Central Drug Research Institute, Lucknow 226001, India
4
Department of Psychiatry, University of Melbourne, Parkville 3010, Australia
5
NaturalPowerMeds Consulting SL, Barcelona 08003, Spain
*
Author to whom correspondence should be addressed.
Received: 7 July 2015 / Revised: 9 October 2015 / Accepted: 27 October 2015 / Published: 2 December 2015
View Full-Text   |   Download PDF [931 KB, uploaded 2 December 2015]   |  

Abstract

Clinical diagnoses of Attention Deficit Hyperactivity Disorder (ADHD) and the use of prescription medications for its treatment have increased in recent years. Current treatments may involve the administration of amphetamine-type substances, a treatment path many parents are apprehensive to take. Therefore, alternative pharmacological treatments are required. Few nutritional or pharmacological alternatives that reduce ADHD associated symptoms (hyperactivity and inattention) have been subjected to rigorous clinical trials. Bacopa monnieri is a perennial creeping herb. CDRI 08 is a special extract of Bacopa monnieri which has been subjected to hundreds of scientific studies and has been shown in human randomized controlled trials (RCTs) to improve memory, attention, and mood. It is hypothesised that chronic administration of CDRI 08 will improve attention, concentration and behaviour in children with high levels of hyperactivity and/or inattention. This paper reports the protocol for the first 16-week, randomized, placebo-controlled, double-blind, parallel groups trial examining the efficacy and safety of CDRI 08 in male children aged 6–14 years with high levels of inattention and hyperactivity. The primary outcome variable will be the level of hyperactivity and inattention measured by the Conners’ Parent Rating Scale (CPRS). Secondary outcome variables include cognition, mood, sleep, and EEG. Trial registration: Australia and New Zealand Clinical Trials Register (ANZCTR): ACTRN12612000827831. View Full-Text
Keywords: bacopa monnieri; CDRI 08; ADHD; inattention; hyperactivity; cognition; RCT bacopa monnieri; CDRI 08; ADHD; inattention; hyperactivity; cognition; RCT
This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. (CC BY 4.0).

Scifeed alert for new publications

Never miss any articles matching your research from any publisher
  • Get alerts for new papers matching your research
  • Find out the new papers from selected authors
  • Updated daily for 49'000+ journals and 6000+ publishers
  • Define your Scifeed now

SciFeed Share & Cite This Article

MDPI and ACS Style

Kean, J.D.; Kaufman, J.; Lomas, J.; Goh, A.; White, D.; Simpson, D.; Scholey, A.; Singh, H.; Sarris, J.; Zangara, A.; Stough, C. A Randomized Controlled Trial Investigating the Effects of a Special Extract of Bacopa monnieri (CDRI 08) on Hyperactivity and Inattention in Male Children and Adolescents: BACHI Study Protocol (ANZCTRN12612000827831). Nutrients 2015, 7, 9931-9945.

Show more citation formats Show less citations formats

Related Articles

Article Metrics

Article Access Statistics

1

Comments

[Return to top]
Nutrients EISSN 2072-6643 Published by MDPI AG, Basel, Switzerland RSS E-Mail Table of Contents Alert
Back to Top