Efficacy of Hammam i Murattib and Ustukhudus with Sibr as an Adjuvant in Parkinsons Disease A Randomized Assessor Blinded Controlled Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Unified Parkinson’s Disease rating scale (UPDRS) Part I + II + III
研究概览
简要总结
Parkinson’s disease (PD) is a common age-related neurodegenerative disorder characterized by motor symptoms such as tremors, stiffness, and slowness of movement, as well as non-motor symptoms like cognitive impairment and mood disorders.PD is the second-most common neurodegenerative disorder that could affect 1–2/1000 of the population at any time, and its prevalence is increasing along with age increasing. This disease affects 1–3% of the population with more than 65 years old.
Pharmacological management of PD could involve administration of levodopa, dopamine agonists, Monoamine oxidase B (MAO-B) Inhibitors, anticholinergics, amantadine and/or Catechol-O-methyltransferase (COMT) Inhibitors. None of these medications has been acted convincingly in order to decelerate or stop the PD progression.
In Unani literature, there is a description of same disease by different name such as Rasha, Istirkha Wa Falij, Zouf-i-Aasab, Zouf-i-Quwa, Ikhtelaj-i-Azlat, Burudat-i-Azlat etc.Parkinsonian tremors can be well visualized in the context of: Rasha as it is one of the essential aspects of Parkinsonism.
In unani literature, Ustukhudus and Sibr is reported as a nerve tonic and neuroprotective agent, and its preparations are recommended for some neurologic disorders. However, the possible useful effects of Ustukhudus and Sibr on Parkinson’s disease (PD) have not been evaluated, yet. Hence, Ustukhudus (Lavandula stoechas L.) and Sibr (aloe) has been chosen as a study drug among the various medications for management of Parkinson as both possess Munaqqi-i-Dimagh, Muqawwi-i-Asab, Mushil-i-Balgham, Mushil-i-Sawda, Muharrik-i-Asab. Along with the drug administration Ilaj bit tadbeer is one of the effective modes of treatment that has been described in Unani system of medicine. In which Hammam is one of the famous regimens practiced all over the world since antiquity. Hammam therapy for the treatment of motor and non-motor symptoms in patients with early-stage PD can have favorable results in terms of slowed movement, dystonia, balance, pain, quality of life, and physical function.
The study emphasizes the need for further validation of the biological mechanisms through which these drugs and therapy reduce the symptoms and signs of Parkinson’s disease. Hence, it has been decided to conduct a clinical study to determine the Efficacy of Hammam-i-Murattib and Ustukhudus (Lavandula stoechas L.) with Sibr (Aloe barbadensis) in patient with Parkinson’s disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 30.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Clinically diagnosed patients of Idiopathic Parkinson’s Disease (PD) with Yahr staging (Hoehn and yahr scale) equal or less than
- •Patients having the age between 30 and 70 years with either gender having initiation of PD symptoms not more than six years.
- •No treatment change within four weeks before the intervention start.
- •Patient who are willing to sign the informed consent form.
排除标准
- •Patients taking selective serotonin reuptake inhibitors (SSRIs), and monoamine oxidase inhibitors (MAOIs).
- •Patients with severe systemic disease Patients who suffered from any complication of standard treatment of PD, including urticaria, pruritus, nausea, vomiting, vertigo, etc.
- •Pregnant and lactating women.
- •Patients who fail to follow up.
结局指标
主要结局
Unified Parkinson’s Disease rating scale (UPDRS) Part I + II + III
时间窗: At baseline, 12th day, 24th day and 35th day
次要结局
- 12-Item Short Form Survey (SF-12)(At baseline, 12th day, 24th day and 35th day)
研究者
Dr Mohammad Najeeb
National Institute of Unani Medicine