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

November 17, 2022 updated by: Ali Amini Harandi, Shahid Beheshti University of Medical Sciences

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Iran, Islamic Republic of
      • Tehran, Iran, Islamic Republic of
        • Shahid Beheshti University of Medical Sciences, Shohada Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: placebo group
Drug: Placebo
placebo capsules filled with stevia sweetened powder
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
neurofunctional outcome using Glasgow Outcome Scale (GOS)
Time Frame: 6 months
6 months
neurofunctional outcome using modified Rankin Scale (mRS)
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shahid Beheshti University of Medical Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 10, 2020

Primary Completion (Actual)

August 12, 2022

Study Completion (Actual)

August 12, 2022

Study Registration Dates

First Submitted

November 11, 2022

First Submitted That Met QC Criteria

November 17, 2022

First Posted (Actual)

November 18, 2022

Study Record Updates

Last Update Posted (Actual)

November 18, 2022

Last Update Submitted That Met QC Criteria

November 17, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IR.SBMU.RETECH.REC.1400.510

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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