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Therapeutic Issues for Autism

NCT03887754 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2019-03-25

No results posted yet for this study

Summary

This study aimed to show the effects of hyperbaric oxygen therapy and/or Risperidone in improving symptoms of autism

Conditions

Interventions

DRUG

Risperidone

It is antipsychotic drug used by dose: 0.25 mg per day in children weighing less than (20 kg); 0.5 mg per day in persons weighing more for 8 months.

DEVICE

hyperbaric oxygen therapy

Sessions were done at pressure 1.5 ATA (atmosphere absolute) with 100% oxygen concentration, each lasting for one hour either in multiplace chamber or in monoplace chamber.

DRUG

Non specific Multivitamin

control group received non specific multivitamins as placebo for 8 months.

Sponsors & Collaborators

  • Minia University

    lead OTHER

Principal Investigators

  • Usama Aly, PhD · Minia University

  • Khaled Khaled, Prof. · Minia University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
7 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2018-01-31
Completion
2018-12-31
FDA Drug
Yes

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03887754 on ClinicalTrials.gov