A Comparative study to evaluate the efficacy of Duloxetine alone and in combination with Alpha Lipoic Acid in patients of painful diabetic peripheral neuropathy
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
研究概览
简要总结
Painful diabetic peripheral neuropathy (PDPN) is a common complication of diabetes that significantly impairs quality of life. Duloxetine, a serotonin–norepinephrine re uptake inhibitor, is an established treatment for PDPN, while alpha lipoic acid (ALA), an antioxidant, has shown beneficial effects in reducing neuropathic symptoms.
This study aims to compare the efficacy and safety of duloxetine alone versus duloxetine in combination with alpha lipoic acid in patients with painful diabetic peripheral neuropathy involving the lower limbs.
In this prospective, randomised, single-blind, parallel-group, active-controlled clinical trial, 60 patients will be allocated into two groups: one group will receive duloxetine alone, and the other will receive duloxetine with alpha lipoic acid for a duration of 6 weeks.
The primary outcome measure will be change in Neuropathic Pain Symptom Inventory (NPSI) score. Secondary outcomes include nerve conduction study parameters, quality of life using SF-12 score, inflammatory biomarkers (IL-6 and TNF-alpha) , and incidence of adverse effects.
The study is expected to provide evidence regarding the additional benefit of alpha lipoic acid when combined with duloxetine in the management of painful diabetic neuropathy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Age more than or equal to 18 years
- •Diagnosed cases of painful diabetic peripheral neuropathy involving lower limbs
- •Either sex
- •HbA1c less than or equal to 8.5%
- •Willingness to participate and provide written informed consent.
排除标准
- •Peripheral neuropathy due to causes other than diabetes
- •Presence of motor weakness/dysfunction in affected limb
- •Recent use of injectable corticosteroids
- •Hepatic or renal dysfunction
- •Known cervical or lumbar radiculopathy
- •History of recent trauma
- •Mental or behavioral disorders affecting participation/compliance
- •History of cerebrovascular accident (stroke) with residual deficits
- •Active infection
- •Prior treatment for diabetic neuropathy without completion of minimum 1-week washout period.
研究者
Kazi Moonfared Ahamed
Jawaharlal Nehru Medical College