Hypoxic Ischaemic Encephalopathy Due to Cardiac Arrest
Conditions
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
Interventions
DRUGMLC 901
MLC901, also known as NeuroAiDII, is a capsule form of drug which should be taken orally and combines nine herbal components
DRUGPlacebo
placebo capsules filled with stevia sweetened powder
Sponsors
Shahid Beheshti University of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
14 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| neurofunctional outcome using Glasgow Outcome Scale (GOS) | 6 months |
| neurofunctional outcome using modified Rankin Scale (mRS) | 6 months |
Countries
Iran
Outcome results
None listed