]>
IRCT20170315033086N6 IRCT 2020-07-19 Tehran University of Medical Sciences The efficacy of Inflawell capsules containing Boswellic acids in patients with cognitive impairment due to traumatic brain injury The efficacy of Inflawell capsules containing Boswellic acids in patients with cognitive impairment due to traumatic brain injury: A Randomized, Double-blind Placebo-controlled Trial 2018-11-22 anticipated 100 Complete https://irct.ir/trial/47581 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Randomization is designed based on four-sized block randomization procedure. A non-ordered computer sequence list including the patient-assigned code and the order of recruitment is generated by an epidemiologist via Stata v.15 software. Given the block size of 4, there are 6 possible ways to equally assign participants to each treatment group. Therefore recruitment of participants to each treatment category is randomized and unpredictable. Following this randomization, an equal number of participants is randomly assigned to each treatment group, Blinding description: Patient allocation and sequencing are done blindly. All the members of the staff who are involved in performing the enrollment, physicians, nurses and the investigation team as well as patients and their guardians, are masked. The research group is uninformed of drug and/or placebo prescription and its dosage. Codes will be written on the sealed envelopes and the medication bottles. Following patient assessment by the doctor, according to the admission sequence, the envelopes with the same number will be opened. Subsequently, the patients are going to be handed a bottle that could be the drug or placebo based on the assigned code. Therefore, the patient is unbeknownst whether the intervention is drug or the placebo. 2 Traumatic brain injury. Intervention 1: Intervention group: Inflawell receiving group, 3 month, 3 times/day, Oral Administration (400 mg), Boswellic acids powder in KondorPharma Pharmaceutical Company (Canada), was encapsulated in orange gelatin capsules (400 mg / capsule) and they were packed in brown container. Intervention 2: Control group: placebo receiving group, 3 month, 3 times/day, oral administration, Microcrystalline cellulose compound was also purchased under the brand name AVICEL (particle diameter: less than 50 micrometers) as placebo from Exir Pharmaceutical Company, Iran and encapsulated in Osweh Pharmaceutical Factory in orange gelatin capsules similar to the drug group (400 mg / capsule) and they were packed in brown container. Yes - There is a plan to make this available What will be shared: collected deidentified IPD, IPD collected for the primary outcome measure only When: Deidentified data will be available starting from April, 2022 To whom: People working in academic institutions or people working in businesses. Conditions: No specific condition Where to obtain: Vajihe Aghamolaie, Roozbeh hospital, Tehran University of Medical Sciences, Tel: 00982155419151, Mobile phone:00989133412204 How to obtain: The process is: 1- Asking a written request contain the main reasons of data importance for the applicant 2- After receiving the request letter, data will be provided in one month. Comments:
public Vajihe Aghamolie
After Lashgar crossroads, South Karegar Street
Tehran Iran (Islamic Republic of) 13337159140 +98 21 5541 9151 vajiheh102@gmail.com Tehran University of Medical Sciences scientific Vajihe Aghamolaie
After Lashgar crossroads, South Karegar St.
Tehran Iran (Islamic Republic of) 13337159140 +98 21 5541 9151 vajiheh102@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) traumatic brain injury patients Patients who are in 3 months to 3 years from the time of traumatic brain injury no limit no limit Both 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 S06.2 Diffuse traumatic brain injury Treatment - Drugs Placebo Intervention group: Inflawell receiving group, 3 month, 3 times/day, Oral Administration (400 mg), Boswellic acids powder in KondorPharma Pharmaceutical Company (Canada), was encapsulated in orange gelatin capsules (400 mg / capsule) and they were packed in brown container Control group: placebo receiving group, 3 month, 3 times/day, oral administration, Microcrystalline cellulose compound was also purchased under the brand name AVICEL (particle diameter: less than 50 micrometers) as placebo from Exir Pharmaceutical Company, Iran and encapsulated in Osweh Pharmaceutical Factory in orange gelatin capsules similar to the drug group (400 mg / capsule) and they were packed in brown container 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). Vice-Chancellor of Research Affairs, Tehran university of medical sciences, Tehran University of Medical Sciences Approved 2018-11-10 Research Ethics CommitteeĜŒ School of Medicine, Tehran University of Medical Sciences, No 1, Poursina St., Ghods St., Keshavarz Blvd, Tehran Tehran Tehran Iran (Islamic Republic of)