Effect of Ambroxol on the Inflammatory Markers and Clinical Outcome of Patients With Diabetic Peripheral Neuropathy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Effect of Ambroxol on NF-κB (or NF-kappaB, "nuclear factor kappa-light-chain-enhancer of activated B cells")
研究概览
简要总结
A prospective, randomized, controlled study will be conducted at Department of Endocrinology, Faculty of Medicine, Ain Shams University, assessing the efficacy of Ambroxol addition on the clinical outcome and inflammatory markers in Diabetic peripheral neuropathy patients
详细描述
All patients presenting to the Endocrinology department, Ain Shams University Hospitals, will be assessed for eligibility as follow:
Inclusion criteria:
- Patients aged 18-75 years diagnosed with Type 2 Diabetes.
- Patients diagnosed with Peripheral Diabetic Neuropathy.
Exclusion criteria:
- Patients with autoimmune disorders (Sjogren's syndrome, lupus, rheumatoid arthritis),inherited disorders causing PN (Charcot-Marie-Tooth), thyroid diseases, patients undergone gastroplasty surgery and cancer patients.
- Pressure on or injury to the nerves
- Patients with severe kidney or liver dysfunction.
- Patients with recent history of / or ongoing infection.
- Patients with cerebral vascular disease, vasculitis, peripheral arterial disease or claudication symptoms, toxic neuritis, vitamin B12 or folate deficiency, spondyloarthropathy, foot edema or ulcer and diagnosis of other neuromuscular disorders or neurodegenerative diseases.
- Use of medications or supplements known to cause peripheral neuropathy.
- Patients consuming alcohol, any antioxidant supplements or anti-inflammatory medicines and drug abuse.
- Ketoacidosis or hypoglycemia resulting in hospital admission within the last 3 months.
- Pregnancy or lactation or expecting to get pregnant during the study.
- Medical, psychological, behavioral or pharmacological factors interfering with ability to participate in trial, collection or interpretation of study data.
- Allergy to ambroxol.
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
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18-75 years diagnosed with Type 2 Diabetes.
- •Patients diagnosed with Peripheral Diabetic Neuropathy.
排除标准
- •Patients with autoimmune disorders (Sjogren's syndrome, lupus, rheumatoid arthritis),inherited disorders causing PN (Charcot-Marie-Tooth), thyroid diseases, patients undergone gastroplasty surgery and cancer patients.
- •Pressure on or injury to the nerves
- •Patients with severe kidney or liver dysfunction.
- •Patients with recent history of / or ongoing infection.
- •Patients with cerebral vascular disease, vasculitis, peripheral arterial disease or claudication symptoms, toxic neuritis, vitamin B12 or folate deficiency, spondyloarthropathy, foot edema or ulcer and diagnosis of other neuromuscular disorders or neurodegenerative diseases.
- •Use of medications or supplements known to cause peripheral neuropathy.
- •Patients consuming alcohol, any antioxidant supplements or anti-inflammatory medicines and drug abuse.
- •Ketoacidosis or hypoglycemia resulting in hospital admission within the last 3 months.
- •Pregnancy or lactation or expecting to get pregnant during the study.
- •Medical, psychological, behavioral or pharmacological factors interfering with ability to participate in trial, collection or interpretation of study data.
- •Allergy to ambroxol.
研究组 & 干预措施
Ambroxol (intervention arm)
40 patients will receive conventional therapy for diabetic neuropathy in addition to ambroxol 450 mg/day divided into 3 doses (each dose consists of 2 75mg capsules) daily for 3 months.
干预措施: Ambroxol Oral Product (Drug)
结局指标
主要结局
Effect of Ambroxol on NF-κB (or NF-kappaB, "nuclear factor kappa-light-chain-enhancer of activated B cells")
时间窗: 3 months
Blood samples will be drawn at baseline and end of study to track changes in NF-kappaB levels using ELISA technique
Effect of Ambroxol on Superoxide dismutase
时间窗: 3 months
Blood samples will be drawn at baseline and end of study to track changes in Superoxide dismutase levels using spectrophotometric technique
Effect of Ambroxol on Tumor necrosis factor alpha (TNF-α)
时间窗: 3 months
Blood samples will be drawn at baseline and end of study to track changes in TNF-α using ELISA technique
次要结局
- Effect of Ambroxol on clinical outcome : Pain assessment using the Numeric rating scale NRS(3 months)
- Effect of Ambroxol on clinical outcome : Michigan diabetic neuropathy score (MDNS)(3 months)
- Effect of Ambroxol on clinical outcome : Toronto clinical scoring systems (TCSS)(3 months)
研究者
Beshoy Thabit
Clinical Pharmacy demonstrator
Ain Shams University