MLC901 in Hypoxic-ischemic Brain Injury Patients; A Double-blind, Randomized Placebo-controlled Trial

Sponsor

Shahid Beheshti University of Medical Sciences (Other)

Overall Status

Completed

CT.gov ID

NCT05621590

Collaborator

(none)

Enrollment

Location

Arms

29.1

Actual Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Hypoxic Ischaemic Encephalopathy Due to Cardiac Arrest	Drug: MLC 901 Drug: Placebo	Early Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

35 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

MLC901 in Hypoxic-ischemic Brain Injury Patients; A Double-blind, Randomized Placebo-controlled Trial

Actual Study Start Date :

Mar 10, 2020

Actual Primary Completion Date :

Aug 12, 2022

Actual Study Completion Date :

Aug 12, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: mlc-901 group	Drug: MLC 901 MLC901, also known as NeuroAiDII, is a capsule form of drug which should be taken orally and combines nine herbal components Other Names: Nueroaid II
Placebo Comparator: placebo group	Drug: Placebo placebo capsules filled with stevia sweetened powder

Arm

Intervention/Treatment

Experimental: mlc-901 group

Drug: MLC 901

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

Other Names:

Nueroaid II

Placebo Comparator: placebo group

Drug: Placebo

placebo capsules filled with stevia sweetened powder

Outcome Measures

Primary Outcome Measures

neurofunctional outcome using Glasgow Outcome Scale (GOS) [6 months]
neurofunctional outcome using modified Rankin Scale (mRS) [6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

14 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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.