NeuroAiD II™ (MLC901) in Mild Traumatic Brain Injury
NCT04861688 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 182
Last updated 2023-03-15
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.
Conditions
Interventions
- COMBINATION_PRODUCT
-
Traditional Chinese Medicine (NeuroAiD II™ (MLC901)
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.
- OTHER
-
Placebo
Placebo with same appearance as active intervention
Sponsors & Collaborators
-
Moleac Pte Ltd.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-08-23
- Primary Completion
- 2023-02-14
- Completion
- 2023-02-14
Countries
- Russia
Study Locations
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