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临床试验/NCT05492019
NCT05492019Unknown2 期

Effect of Doxycycline in Levodopa Treated Parkinson's Disease Patients: Randomized, Double-Blind, Placebo-Controlled Trial.

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年7月1日最近更新:
适应症
干预措施

试验速览

阶段
2 期
发起方
入组人数
60
试验地点
1
主要终点
Effect of doxycycline on improvement of motor performance and cognitive functions of Parkinson's disease.

研究概览

简要总结

This study is a Randomized, Double-Blind, Placebo-Controlled Trial. The objective of the study is to assess the effect of doxycycline in levodopa treated Parkinson's disease patients regarding motor performance and cognitive functions. Parkinson's disease patients on levodopa medications will be assigned to receive doxycycline 50mg twice daily or placebo over 8 weeks. The motor and cognitive symptoms of Parkinson's disease will be assessed after 4 weeks and 8 weeks follow up.

详细描述

Parkinson's disease is a progressive neurodegenerative disorder that is caused by degeneration of dopaminergic neuron in the substantia nigra. Most commonly used drug, levodopa can improve the dopamine level in brain but cannot give neuroprotection and also induces motor fluctuations and dyskinesia in many patients. Doxycycline has been shown anti-inflammatory and neuroprotective effects against Parkinson's disease on animal model. It also reduced Levodopa induced dyskinesia without compromising the motor benefits of Levodopa. Therefore, the present study is to attempt to improve the sign symptoms of Parkinson's disease by giving doxycycline along with Levodopa.

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 doxycycline 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 after 4 weeks and 8 weeks follow up.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Investigator)

盲法说明

Participants and investigators will not know which arm patients have been assigned to or if they receive doxycycline or placebo.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosed Parkinson's disease patient taking Levodopa
  • Age: More than 18 years

排除标准

  • Secondary causes of parkinsonism
  • Atypical parkinsonian syndromes
  • Prior stereotaxic surgery for Parkinson's disease
  • Known hypersensitivity to doxycycline
  • Pregnancy and lactation
  • Suffering from active malignancy

研究组 & 干预措施

Doxycyline- Patients receiving Doxycycline .

Experimental

Drug generic name: Doxycycline Dosage form- oral capsule Dosage- (50mg) one capsule Frequency- twice daily Duration- 8 weeks.

干预措施: Doxycycline (Drug)

Control- Patients receiving placebo

Placebo Comparator

Patient will receive one capsule of placebo twice daily

干预措施: Placebo (Drug)

结局指标

主要结局

Effect of doxycycline on improvement of motor performance and cognitive functions of Parkinson's disease.

时间窗: 8 weeks

Assessing and comparing the severity of symptoms of Parkinson's disease of two groups by using MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) at baseline, 4 weeks and 8 weeks following doxycycline and placebo supplementation.

次要结局

  • High sensitive C-reactive protein(8 weeks)

研究者

发起方
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Shahanaz Parvin

MBBS

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

研究点 (1)

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