NCT05621590

Brief Summary

In a randomized, placebo-controlled trial, 35 patients with HIBI were randomly designated to receive either MLC901 or placebo capsules over six months. We evaluated patients in two groups by modified Rankin Scale (mRS) and Glasgow outcome scale (GOS) to examine their state of disability and recovery

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P50-P75 for early_phase_1

Timeline
Completed

Started Mar 2020

Typical duration for early_phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 10, 2020

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 12, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 12, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 11, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 18, 2022

Completed
Last Updated

November 18, 2022

Status Verified

November 1, 2022

Enrollment Period

2.4 years

First QC Date

November 11, 2022

Last Update Submit

November 17, 2022

Conditions

Hypoxic Ischaemic Encephalopathy Due to Cardiac Arrest

Outcome Measures

Primary Outcomes (2)

  • neurofunctional outcome using Glasgow Outcome Scale (GOS)

    6 months

  • neurofunctional outcome using modified Rankin Scale (mRS)

    6 months

Study Arms (2)

mlc-901 group

EXPERIMENTAL
Drug: MLC 901

placebo group

PLACEBO COMPARATOR
Drug: Placebo

Interventions

MLC 901DRUG

MLC901, also known as NeuroAiDII, is a capsule form of drug which should be taken orally and combines nine herbal components

Also known as: Nueroaid II
mlc-901 group
PlaceboDRUG

placebo capsules filled with stevia sweetened powder

placebo group

Eligibility Criteria

Age14 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • an initial cardiac arrest leading to coma, successful return of spontaneous circulation, and persistent coma after the return of spontaneous circulation.

You may not qualify if:

  • pregnancy, cardiogenic shock (systolic blood pressure less than 90 mm Hg despite epinephrine infusion), possible causes of coma other than cardiac arrest (drug overdose, head trauma, or cerebrovascular accident), an underlying background of known acute or chronic disease including renal failure, liver or pulmonary disorders, previous stroke, dementia, and brain injury.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shahid Beheshti University of Medical Sciences, Shohada Hospital

Tehran, Iran

Location

Related Publications (1)

  • Pakdaman H, Amini Harandi A, Gharagozli K, Abbasi M, Ghaffarpour M, Ashrafi F, Delavar Kasmaei H, Amini Harandi A. MLC601 in vascular dementia: an efficacy and safety pilot study. Neuropsychiatr Dis Treat. 2017 Oct 5;13:2551-2557. doi: 10.2147/NDT.S145047. eCollection 2017.

    PMID: 29042785BACKGROUND

MeSH Terms

Interventions

Neuroaid

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor

Study Record Dates

First Submitted

November 11, 2022

First Posted

November 18, 2022

Study Start

March 10, 2020

Primary Completion

August 12, 2022

Study Completion

August 12, 2022

Last Updated

November 18, 2022

Record last verified: 2022-11

Locations

IR(1)