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IRCT20200415047096N1 IRCT 2020-09-09 Kerman University of Medical Sciences Effects of Combination Therapy of Baclofen & Trihexyphenidyl on Spasticity in Brain Injury Patients Effects of Combination Therapy of Baclofen & Trihexyphenidyl on Early Onset Spasticity in Post Traumatic Brain Injury Patients 2020-03-31 anticipated 90 Complete https://irct.ir/trial/47397 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Factorial, Purpose: Treatment, Randomization description: In this study, patients randomly divided in three groups (30 patients in each group) using random allocation sequence with SAS statistical software. According to this method, a simple randomization list product and patients` involvement in each group determine base on order entry. we used sequentially numbered sealed opaque for allocation concealment, Blinding description: This study was double blinded study. The tablets will be given by oral Gavage. Due to the patient's anesthesia, one side will be blind. The treatment regimen is also given by the nurse and therefore the Spasm assessment Physician will also be unaware of the treatment protocol. 2 Spasticity in Post Traumatic Brain Injury Patients. Intervention 1: Intervention group: In addition to baclofen, Trihexyphenidyl 1 mg per day with increasing dose of Trihexyphenidyl up to a maximum of 8 mg per day if no response and the initial dose of baclofen remains constant. Intervention 2: Control group: Only baclofen is taken with an initial dose of 5 mg three times a day with an increase of 5 mg every three days to a maximum dose of 25 mg three times a day if no response. Intervention 3: Intervention group: Baclofen and Trihexyphenidyl provided that the initial dose of Trihexyphenidyl remains constant and the dose of baclofen increases if the first group does not respond similarly. Yes - There is a plan to make this available What will be shared: At the end of the study, some of the information, including the effect of a combination of baclofen and Trihexyphenidyl (with two different doses) on the early treatment of spasm following trauma in stroke patients, was shared with health workers. When: 2 months after data analysis To whom: Health researchers Conditions: In order to use the results and during the written request Where to obtain: Pedram Arfa- Email How to obtain: The purpose of accessing data - requesting e-mail Comments:
public Pedram Arfa
Gharani
Kerman Iran (Islamic Republic of) 7613747181 +98 34 3223 5011 parfaf@gmail.com Kerman University of Medical Sciences scientific Mohsen Shahba
GHarani
kerman Iran (Islamic Republic of) 7613747181 +98 34 3223 5011 mshahba@kmu.ac.ir Kerman University of Medical Sciences Iran (Islamic Republic of) Early Onset Spasticity in Post Traumatic Brain Injury Patients no limit no limit Both The level of consciousness (GCS) is equal to 3 out of 15 Severe drug side effects following baclofen or Trihexyphenidyl History of severe allergy to baclofen or Trihexyphenidyl Dyskinetic G80.3 Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group: In addition to baclofen, Trihexyphenidyl 1 mg per day with increasing dose of Trihexyphenidyl up to a maximum of 8 mg per day if no response and the initial dose of baclofen remains constant Control group: Only baclofen is taken with an initial dose of 5 mg three times a day with an increase of 5 mg every three days to a maximum dose of 25 mg three times a day if no response. Intervention group: Baclofen and Trihexyphenidyl provided that the initial dose of Trihexyphenidyl remains constant and the dose of baclofen increases if the first group does not respond similarly. Spasm in the muscles of the wrist flexor muscles on one side. Timepoint: Spasm in the flexor muscles of the wrist on one side (left hand) is recorded on First day, third day, seventh day, first month, third month, and sixth month after administration. Method of measurement: Modified Ashworth Scale. Kerman University of Medical Sciences Approved 2020-04-24 Ethics committee of kerman University of Medical Sciences Kerman,The beginning of Haft Bagh Alavi Road, Kerman University of Medical Sciences Campus Kerman Kerman Iran (Islamic Republic of)