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IRCT20190427043389N5 IRCT 2023-12-11 Zanjan University of Medical Sciences Investigating the effect of ondansetron on Levodopa-induced dyskinesia in patients with parkinson's disease Investigating the effect of ondansetron on Levodopa-induced dyskinesia in patients with parkinson's disease 2023-12-21 anticipated 32 Complete https://irct.ir/trial/74003 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Eligible people will be selected from the usual referrals to the neurology clinic of Vali Asr Zanjan educational center by the available method and then will be allocated to two groups by random block method (blocks of 4). The first group will receive oral tablets of ondansetron and the second group will receive placebo. For this purpose, blocks of 4 will be selected using a table of random numbers in the size of 16 blocks so that the sample size reaches 32 people. Blocking will be done by a person not involved in sampling. Each of the generated random sequences will be recorded on a card and the cards will be placed in the envelopes in order. Finally, the lids of the envelopes will be glued and placed inside a box. At the start of the intervention to identify the order of the participants, one of the envelopes will be opened in order and the assigned group of that participant will be revealed, Blinding description: In this study, people will be assigned to two groups by random block method (blocks of 4). Patients will be blinded in this study. One group will receive standard treatment along with ondansetron tablets, while the other group will receive standard treatment along with a placebo. Placebo tablets are very similar to ondansetron tablets in terms of color, shape and size, but do not contain the active drug. 3 levodopa-induced dyskinesia. Intervention 1: Intervention group: will take ondansetron tablets in the form of 8 mg daily orally in the first week and then in the form of 12 mg daily (8 mg in the morning and 4 mg at night) from the second to the eighth week for two months. Intervention 2: Control group: will receive the placebo in the order of the first week, two in the morning, and then, from the second to the eighth week, two in the morning and one in the evening. Yes - There is a plan to make this available What will be shared: Part of the data, such as the information related to the main outcome, can be shared. When: 3 months To whom: Researchers Conditions: A person can access the data after requesting the person in the charge of the trial and checking her reliability. Where to obtain: Central Library of Zanjan University of Medical Science How to obtain: A person can access the data after requesting the person in the charge of the trial and checking her reliability. Comments:
public Hamed Ghavimi
Gavazang Road, next to ayatollah mousavi hospital, Faculty of Pharmacy, Zanjan
Zanjan Iran (Islamic Republic of) 4513956184 0098 24 334736354 Hamed.ghavimi@gmail.com Zanjan University of Medical Sciences scientific Dr. Hamed Ghavimi
Gavazang Road, Next to Ayatollah Mousavi Hospital, Faculty of Pharmacy, Zanjan
Zanjan Iran (Islamic Republic of) 4513956184 +98 24 3347 3635 Hamed.ghavimi@gmail.com Zanjan University of Medical Sciences Iran (Islamic Republic of) patients with Parkinson's disease stages 3, and 4 based on Hoehn and Yahr scale age over 18 years patients with levodpa induced dyskinesia Patient satisfaction 18 years no limit Both Allergy to ondansetron (rash, itching) Concomitant use of apomorphine in patients with off episodes pregnancy breastfeeding The patient's unwillingness for participation G21.11 Neuroleptic induced parkinsonism Treatment - Drugs Placebo Intervention group: will take ondansetron tablets in the form of 8 mg daily orally in the first week and then in the form of 12 mg daily (8 mg in the morning and 4 mg at night) from the second to the eighth week for two months. Control group: will receive the placebo in the order of the first week, two in the morning, and then, from the second to the eighth week, two in the morning and one in the evening. Levodopa induced dyskinesia score in Unified Dyskinesia Rating Scale questionnare. Timepoint: Before intervention, one and two months after starting intervention. Method of measurement: Unified Dyskinesia Rating Scale questionnare. Levodopa-induced dyskinesia 's severity. Timepoint: Before starting intervention, one and two months after starting intervention. Method of measurement: Unified Dyskinesia Rating Scale questionnare. Zanjan University of Medical Science Approved 2023-10-31 Research Ethics Committee of Zanjan University of Medical Science Jomhouri Street, Azadi Boulevard, University Headquarters, 1st floor, Deputy of Research and Technology, Zanjan University of Medical Science Zanjan Zanjan Iran (Islamic Republic of)