Efficacy of Variable Doses of Pregabalin Vs Duloxetine in Diabetic Peripheral Neuropathic Pain: A Comparative Study
试验速览
- 阶段
- 早期 1 期
- 入组人数
- 126
- 主要终点
- visual analogue scale score.
研究概览
简要总结
Background Diabetic neuropathy is a widespread, debilitating condition and its management needs a significant cost. Around, 50% of diabetes mellitus (DM) patients suffer from Diabetic Peripheral Neuropathic Pain (DPNP). According to the reported data, specific anticonvulsants and antidepressants are effective for coping diabetic peripheral neuropathy. Two drugs, duloxetine and pregabalin, are officially permitted by the Food and Drug Administration (FDA) for the management of DPNP.
Methodology A Prospective Randomized Controlled Trial (RCT) trial for 12 weeks will be carried out on 126 volunteer DPNP patients with age between 18- to 70-year-old and participants was selected through consecutive sampling and will be evaluated on the basis of duration of the disease, pain scales and the data provided by particular consultants. The parameters will be measured weekly and final parameters will be measured after 12 weeks. Statistical analysis will be carried out by SPSS, ANOVA, and t-test.
Expected outcomes:
From this experimental design, investigators are expecting improvement in the management of DPNP and Duloxetine is more effective for treating patients suffering from DPNP.
详细描述
This is prospective clinical research, that will be executed from Feb 2022 to May 2022, including, only those patients who are diagnosed with DPNP of at least six months duration, attending Rehman Medical Institute, General hospital. The diagnosis will be primarily clinical.
Randomization of participants will be accomplished by registering the patients into any of two groups (Duloxetine group A, Pregabalin group B) using a statistical computer program. In group A (Duloxetine group) patients will receive duloxetine 30mg/day and group B (Pregabalin group) will receive Pregabalin 75 mg/day for upto 12 weeks.
Biothesiometry will be performed for all diagnosed diabetic patients. Relevant clinical tests like HBA1c, Lipid profile, TSH, vitamin B12 levels will be performed in all patients before randomization.
The sample size was calculated using an open epi sample size calculator using confidence interval 95%, power 80.
Mean ±SD of Duloxetine group was 5.60 ±0.89. Mean ±SD of Pregabalin group was 6.01±0.82. Pregabalin group sample size was calculated to be 63 patients, Duloxetine group sample size was calculated to be 63 patients. Total number of participants was 126.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Both male and female patient with age more than 18 years to 70 years.
- •Patients diagnosed with peripheral neuropathic pain affected by diabetes from at least 24 weeks and all other causes off peripheral painful neuropathy has been already excluded by their primary physician.
- •Patients who may agree with written inform consent.
- •HbA1c ≥ 6.5% and ≤ 10%
排除标准
- •Patients with severe hepatic disease, cardiovascular diseases, Epilepsy and respiratory diseases or any other medical or psychiatric disorders.
- •Patients with uncontrolled hypertension.
- •DM patients with foot ulcers, foot injuries or any other painful lesion.
- •Patients who are already using or used duloxetine or pregabalin in last three month.
- •Pregnant women or those who may not agree to use medical recommended birth control procedures during the treatment.
- •Patient with thyroid known disorders or diagnosed during the screening
- •Vitamin B12 deficient patient
- •Chronic alcoholics
- •DKD, with eGFR < 30ml/min
- •Hypertriglycedmia (TGs more then 250mg/dl)
研究组 & 干预措施
Duloxetine Group
Oral intake Duloxetine tablets, 30mg/day for 12 weeks.
干预措施: Duloxetine Tablets, (Drug)
Pregabalin Group
Oral intake of Pregabalin tablets, 75 mg/day for 12 weeks.
干预措施: Pregabalin Tablets (Drug)
结局指标
主要结局
visual analogue scale score.
时间窗: 3 months.
Evaluation perceived pain intensity by patients
Toronto clinical neuropathy score
时间窗: 3 months.
Final diagnosis and staging of diabetic peripheral neuropathy of patients. Diabetes severity will be graded according to the results of this score. Out of a total score of 19, the grades are defined as follows: 0-5 = no neuropathy; 6-8 = mild neuropathy; 9-11 = moderate neuropathy; ≥ 12 = severe neuropathy.
次要结局
未报告次要终点
研究者
NASEER AHMED
Fahim Ullah, Assistant professor.
Rehman Medical Institute - RMI