Clinical Trials

A key challenge in validating complementary medicine is to systematically assess and evaluate clinical outcomes using scientific research methodologies. Clinical research contributes to improved health by providing new options for disease management and prevention that can be directly integrated into mainstream health practices.

NICM HRI's clinical program concentrates on four key nodes:

• Women's health
• Vascular dementia
• Cardiovascular health
• Gastroenterology

Partnerships with other institutions as well as various specialist centres nationally and internationally has created a productive network of leading clinical experts and facilities.

NICM HRI's clinical research projects are undertaken in accordance with global standards of Good Clinical Practice using Standard Operating Procedures, and have been published in high-quality medical journals. NICM HRI has successfully completed clinical trials on the evaluation of herbal medicines and/or acupuncture for health conditions such as:

• Irritable bowel syndrome
• Infertility
• Endometriosis
• Menopause
• Vascular dementia
• Dysmenorrhoea
• Metabolic syndrome
• Diabetes
• Delayed onset muscle soreness
• Cold sores
• Hepatitis C
• Eating disorders
• Management of cancer treatment related symptoms

NICM HRI is currently undertaking the following clinical trials:

Other current projects include:

• Effects of acupuncture on cognitive function in healthy adults
• Strengthening NICM's clinical trials platform through the Evado electronic data capture system, and analytical chemistry instrumentation required for herbal medicine definition
• Synergistic activity of herbal medicines in stroke
• Protocol to conduct a dose-ranging randomised placebo controlled clinical trial to evaluate the safety and tolerability of the traditional Chinese medicine formulation "Concord Care 1 (CC1)" in palliative cancer patients
• Assessing health literacy in a population of complementary medicine users
• Clinical trial to evaluate the effectiveness and safety of Nao Xin Qing for treatment of Ischemic Stroke

Clinical Research Facilities

Key technologies include:

• Psychophysiological assessment with continuous measures of:
  • Electroencephalograph (EEG) using Compumedics® Neuroscan Synamps 2 with 64 channel Ag/AgCl electrode caps
  • Electrocardiograph (ECG)
  • Skin conductance
  • Peripheral pulse pressure
  • Respiration
• Neuropsychological assessment:
  • Complete standardised neuropsychological assessment batteries delivered by research psychologists
  • Validated computerised cognitive assessment batteries including CogState®
• Cardiovascular assessment:
  • Vascular, echocardio, and transcranial doppler ultrasound
  • Central arterial pressure pulse wave analysis SphygmoCor®

Clinical research at NICM HRI is also supported by a well equipped onsite consultation room and access to the UniClinic for clinical trials. Good Clinical Practice (GCP) standards are supported through the use of software such as Epigeum (GCP training) and Evado (FDA compliant data management software).