CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 182 enrolled
Drug / intervention
Traditional Chinese Medicine (NeuroAiD II™ (MLC901) +1 morecombination
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04861688
NCT04861688Phase 3Completed
CompareCT.gov

A Randomized Double-blind, Placebo-controlled, Multi-center Trial to Investigate the Efficacy and Safety of NeuroAiD II™ (MLC901) to Improve Cognitive Functioning in Non-surgical Mild Traumatic Brain Injury Patients

Moleac Pte Ltd.·interventional·Posted Apr 27, 2021·Updated Mar 15, 2023

In Brief

A Phase 3 clinical trial evaluating Traditional Chinese Medicine (NeuroAiD II™ (MLC901) and Placebo for Traumatic Brain Injury. Completed, enrolled 182 participants across 4 sites.

Detailed Summary

A Randomized Double-blind, Placebo-controlled, Multi-center Trial to determine the efficacy of NeuroAiD II™ (MLC901) in improvement of cognitive functioning of adult patients with long-term cognitive impairment following mild traumatic brain injury (mTBI) and to assess safety of NeuroAiD™ (MLC901) in these patients.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTraumatic Brain Injury
CountriesRussia
Collaborators--

Timeline

Phase 3CompletedFinished
20222023202420252026
First PostedApr 27, 2021
Enrollment StartAug 23, 2021
Primary CompletionFeb 14, 2023
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 5.2 years ago

Interventions

Traditional Chinese Medicine (NeuroAiD II™ (MLC901)combination

NeuroAiD II™ (MLC901) contains the extracts of 9 botanical active ingredients blended with commonly used excipients. The 9 botanical active ingredients are traditional herbs well documented in the Pharmacopoeia of the People's Republic of China.

Placeboother

Placebo with same appearance as active intervention