A Clinical Study on Evaluation of Comparative Efficacy of Waj versus Pregabalin in Diabetic Peripheral Neuropathy
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Improvement in Visual Analogue Scale (VAS)
研究概览
简要总结
Subjects having clinical features of DPN will be screened, and those who fulfill the inclusion criteria should be enrolled in a 60-day clinical trial after obtaining written informed consent. They will be randomly allocated into two groups (computer-generated random numbers will be used for randomization), viz, group A and group B (n = 75 in the test and 75 in the control group). Subjects in group A will be given the test drug in the dosage form as mentioned above. Whereas, subjects in Group B will receive a capsule of Pregabalin in the above-mentioned dose. Baseline clinical parameters such as burning, aching pain, numbness, and prickling sensation will be assessed using a 10-point VAS (score 0=no symptom and 10=unbearable symptom)52 and VPT by using the NEURO TOUCH device by the investigator. DNS and TCSS will be calculated on each follow-up visit by summation of scores on all parameters for a patient. EuroQol 5 Dimension 5-Level (EQ-5D-5L) Questionnaires will be calculated at baseline and 60th day of the trial for assessing the quality of life. Follow-up will be on every 15th day, for assessment of clinical cure up to 60th day, except VPT (pre and post) and post treatment follow up for 30 days. Safety parameters will be done before and after the completion of the trial. The pre- and post-intervention objective findings (effects) will be assessed statistically. All the above interventions will be using orally for 60 days. The Frequency & dose of rescue medicine mentioned in each group. The objective parameters VAS will be measured at baseline, 15th day, 30th day, 45th day, and 60th day, and & VPT at baseline and 60th day respectively.
Statistical Analysis
Efficacy analysis will be performed on intention-to-treat (ITT) principles using the last observation carry forward method (LOCF). The study data will be analysed statistically with appropriate tests. Changes in various parameters will be assessed for statistical evaluation by using a categorical scale, non non-parametric setting for qualitative data analysis. Whereas, repeated measures ANOVA and one-way ANOVA with Tukey post hoc multiple comparison test (on continuous scale) for both intergroup & intragroup analysis at every follow-up. Leven`s test will be performed to assess the homogeneity of variance. Results on continuous measurements will be presented on Mean, SD, and results on categorical measurements will be presented in Number (%).
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 30.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Diagnosed cases of DPN with Type 2 DM.
- •History of DPN with or without medication within the period of 6 months to 60 months.
- •Subjects of DPN with Toronto clinical scoring system score more than 5 up to
- •HbA1c less than
- •All genders.
- •Age between 30 and 60 years.
- •Normotensive (without taking any anti-hypertensive medicines).
排除标准
- •Known cases of peripheral nerve dysfunction; vitamin deficiency (B12 and E), peripheral vascular disease (peripheral artery disease, varicose vein, deep vein thrombosis, Raynaud’s disease, Buerger’s disease).
- •History of positive alcoholism.
- •Patient on Insulin.
- •Known history of thiazolidinedione antidiabetic agents (peripheral edema with pregabalin).
- •Patients with a history of Cancer, Autoimmune diseases (Multiple sclerosis, GB syndrome, Myasthenia gravis), and vasculitis (Polyarteritis nodusa).
- •Pregnant & lactating mothers.
结局指标
主要结局
Improvement in Visual Analogue Scale (VAS)
时间窗: For VAS at every 15th day (0th, 15th, 30th, 45th, and 60th). | For VPT pre and post.
Improvement in vibration perception threshold (VPT)
时间窗: For VAS at every 15th day (0th, 15th, 30th, 45th, and 60th). | For VPT pre and post.
次要结局
- Improvement in TCSS.(Improvement in DNS.)