The efficacy of Inflawell capsules containing Boswellic acids in patients with cognitive impairment due to traumatic brain injury

Phase 2

• Conditions: Traumatic brain injury.; Diffuse traumatic brain injury; S06.2

• Registration Number: IRCT20170315033086N6
• Lead Sponsor: Tehran University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 26 April 2021

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

traumatic brain injury patients
Patients who are in 3 months to 3 years from the time of traumatic brain injury

Exclusion Criteria

Patients with uncontrollable seizures
Patients with impaired level of consciousness
Patients with (Glasgo outcome scale) GOS less than 3
Taking anticholinergic drugs
Taking anticonvulsants and sedatives drugs (such as Phenytoin, Topiramate, Levetiracetam)
Epidural hematoma, subdural hematoma and Contusion
substance abuse
Previous brain trauma
Multiple sclerosis, Bipolar mood disorder, Schizophrenia, aphasia, spinal cord injury, motor disorder
Lactation and pregnanacy

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cognitive impairment intensity. Timepoint: At the commencement of the investigation and after taking Inflawell capsules. Method of measurement: Rey Auditory Verbal Learning Test-Recognition Test (AVLT-R), Wechsler adult intelligence Digit Symbol Substitution Test (DSST) and trail-making test part B (TMT-B).