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

Early Phase 1CompletedNCT05621590

Shahid Beheshti University of Medical Sciences35 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Hypoxic Ischaemic Encephalopathy Due to Cardiac Arrest

Interventions

MLC 901DRUG

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

PlaceboDRUG

placebo capsules filled with stevia sweetened powder

Eligibility

Sex: ALLMin age: 14 Years

Medical Language ↔ Plain English

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.

Locations (1)

Shahid Beheshti University of Medical Sciences, Shohada Hospital

Tehran, Iran

Outcomes

Primary Outcomes

neurofunctional outcome using Glasgow Outcome Scale (GOS)

Time frame: 6 months

neurofunctional outcome using modified Rankin Scale (mRS)

Time frame: 6 months

Data from ClinicalTrials.gov

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