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NEURoaid II (MLC 901) Assessment in Cognitively Impaired Not Demented Subjects

NCT01847924 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 103

Last updated 2018-07-27

No results posted yet for this study

Summary

Patients who have suffered from stroke may develop problems with thinking. Moreover, such patients have a high risk of becoming demented, more dependent or dying. Therefore, further studies are urgently needed to find effective and safe treatments.

Neuroaid is a Traditional Chinese Medicine which has been shown to stimulate growth of brain cells and connections in animals. Neuroaid may improve blood flow in the brain and functional recovery after stroke in patients. Neuroaid-II is a simplified formula with only the main 9 herbal ingredients of the original formula and no animal ingredients.

The NEURoaid II (MLC 901) assessment in cognitively Impaired not demented subjects: a pilot double blind, placebo-controlled randomized Trial on Efficacy and Safety (NEURITES) Study is a 24-week, early phase trial of Neuroaid-II in patients who have thinking problems after stroke. The study aims to investigate the effectiveness of the study drug in improving cognitive performance. The safety of the study drug will be closely monitored using adverse events, laboratory tests and vital signs.

The trial is important as it aims to set new standards for the scientific evaluation of Asian Traditional Medicine for integration into standard medicine practice. It may potentially establish a novel therapeutic approach for improving cognition after stroke.

Conditions

Interventions

DRUG

MLC901

24 weeks intervention with orally MLC901. 2 capsules 3 times a day

DRUG

Placebo

24 weeks intervention with orally placebo. 2 capsules 3 times a day

Sponsors & Collaborators

  • National University Hospital, Singapore

    lead OTHER

Principal Investigators

  • Christopher LH Chen, FRCP · National University Hospital, Singapore

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
55 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-03-31
Primary Completion
2018-04-30
Completion
2018-04-30

Countries

  • Philippines
  • Singapore
  • Vietnam

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01847924 on ClinicalTrials.gov