Effect of Folic Acid in Levodopa Treated Parkinson's Disease Patients
NCT ID: NCT05959044
Last Updated: 2023-09-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
60 participants
INTERVENTIONAL
2023-04-16
2024-07-16
Brief Summary
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Detailed Description
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This study is a Randomized, Double-Blind, Placebo-Controlled Trial and conducting at Department of Pharmacology, BSMMU in collaboration with Department of Neurology, BSMMU. A total of 60 patients suffering from Parkinson's disease is selected according to inclusion and exclusion criteria. The diagnosis of the patients suffering from Parkinson's disease will be performed by a neurologist at movement disorder clinic of department of Neurology, BSMMU. Patients will undergo MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) to assess the severity of the disease. The patients will be randomly allocated into two arms: control and intervention. Patients in intervention arm consisted of 30 patients who will receive levodopa plus folic acid orally for 8 weeks. On the other hand, control arm consisted of 30 patients who will receive levodopa plus placebo for 8 weeks. The severity of Parkinson's disease will be assessed 8 weeks follow up.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Folic acid
30 patinets will receive Orally 5mg tablet two times daily for 8 weeks
Folic Acid Tablet
oral 5mg tablet two times daily for 8 weeks
Control
30 patinets will receive Orally 5mg tablet two times daily for 8 weeks
Placebo
orally 5mg two times daily for 8weeks
Interventions
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Folic Acid Tablet
oral 5mg tablet two times daily for 8 weeks
Placebo
orally 5mg two times daily for 8weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Mild to moderate Parkinson's disease patient according to Hoehn and Yahr staging, stage -I, II, III
* Homocysteine level ≥ 13 µmol/L
Exclusion Criteria
* Prior stereotactic surgery for PD
* Suffering from active malignancy
* Known hypersensitivity to folic acid
* Multivitamin supplementation within 30 days of enrollment
* Patients taking anticonvulsant, oral contraceptive pill, disease modifying anti-rheumatic drugs
* Pregnancy or lactating mother
* Has any clinically significant medical condition that could interfere with the subject's ability to safely participate in the study or to be followed
18 Years
ALL
Yes
Sponsors
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Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
OTHER
Responsible Party
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Dr. Shimu Akter Ayshi
MD Resident
Locations
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BSMMU
Dhaka, , Bangladesh
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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BSMMU/2023/6247
Identifier Type: -
Identifier Source: org_study_id
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