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IRCT20200708048060N1 IRCT 2022-06-06 Tehran University of Medical Sciences Gingko Biloba efficacy in treatment of drug-induced parkinsonism Assessment of Gingko Biloba efficacy in treatment of drug-induced parkinsonism:; A randomized, double-blind, placebo-controlled clinical trial 2022-06-20 anticipated 102 Complete https://irct.ir/trial/49589 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patient randomization is based on simple randomization method. Thus, based on the table of random numbers, even numbers are considered for the Ginkgo receiving group and odd numbers for the placebo receiving group. The statistical software used for randomization is R, Blinding description: One of the out-of-field researchers prepared a random sequence of patients and coding the drug packages of each patient. Drugs and placebo tablets, which are similar in appearance, are taken into similar boxes. All tablets required by each patient are packed in coded boxed during the study period. The patient listing is also provided to the field-based researcher based on these codes. All clinical evaluations will be performed by another researcher in the field who is not involved in the allocation process. 2-3 drug-induced parkinsonism. Intervention 1: Intervention group: Intervention group: Ginkgo biloba tablets - 40 mg every 8 hours 2 tablets (daily dose 240 mg) - for 3 months - drug manufacture: tolid darou. Intervention 2: Control group: placebo tablets - every 8 hours 2 tablets for 3 months - drug manufacture: tolid darou. Yes - There is a plan to make this available What will be shared: Information about the study process, demographic information and patients' disease conditions, results of questionnaires and statistical analysis When: starting immediately after publication To whom: for researchers Conditions: Use of documentation for other research and improvement of patients Where to obtain: Refer to the related researcher (Arash Kalantar) at Email address below arash_kalantarmehrjardi@yahoo.com How to obtain: Refer to the sites where the study was published, act via email and respond within one week after receiving the email. Comments:
public Niayesh Mohebbi
Faculty of pharmacy, Tehran university of medical sciences, 16 Azar Avenue, Enqelab Square, Tehran,
Tehran Iran (Islamic Republic of) 1417614411 +98 21 6695 4709 niayesh_mohebbi@yahoo.com Tehran University of Medical Sciences scientific Fatemeh Mohammadian
After Lashgar intersection, South Karegar street
Tehran Iran (Islamic Republic of) 13337159140 +98 21 5541 9151 fm4568@yahoo.com Tehran University of Medical Sciences Iran (Islamic Republic of) All psychiatric patients with the symptoms of drug induced parkinsonism, who have been given neurological counseling and Parkinson's drug-induced event has been confirmed based on clinical judgments and other findings among them Age over 18 years 18 years no limit Both Thrombocytopenia Coagulopathy Kidney failure Liver failure GI bleeding history Consumption of warfarin, high dose NSAIDs or NSAIDS with SSRIs and CCBs. G21.21 Other drug-induced secondary parkinsonism Treatment - Drugs Treatment - Drugs Intervention group: Intervention group: Ginkgo biloba tablets - 40 mg every 8 hours 2 tablets (daily dose 240 mg) - for 3 months - drug manufacture: tolid darou Control group: placebo tablets - every 8 hours 2 tablets for 3 months - drug manufacture: tolid darou Improving the severity of drug induced parkinsonism symptoms in patients. Timepoint: before intervention and 1 and 3 months after intervention. Method of measurement: Unified Parkinson's Disease Rating Scale ( UPDRS ) questionnaire Simpson-Angus Extrapyramidal Side Effects Scale (SAS ) questionnaire. Improving the cognitive function in patients. Timepoint: before intervention and 1 and 3 months after intervention. Method of measurement: MoCA (Montreal Cognitive Assessment) questionnaire. Improving the quality of life of patients. Timepoint: before intervention and 1 and 3 months after intervention. Method of measurement: PDQ-39 questionnaire. Tehran University of Medical Sciences Approved 2019-12-19 Ethics committee of Tehran University of Medical Sciences 13th floor, block A, Headquarters of the Ministry of Health, Treatment and Medical Education, Simaye-Iran st., between Zarafshan and south Falamak st., Shahrak Qods, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)