A Randomized, Open Label, Comparative, Clinical Study To Evaluate The Efficacy And Safety of Trumove Tablet In Patients With Diabetic Neuropathic Pain
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- 1. Time to onset of relief of pain [ Time frame: in number of days]
研究概览
简要总结
- The subjects who fulfilled the inclusion and exclusion criteria will be enrolled in the study.
- 30 Participants will be randomized into 2 groups with 15 in each group.
- Arm 1 - Trumove Tablet: 15 study participants
- Arm 2 - Pregabalin Tablet: 15 study participants
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients who are able to understand written and/or verbal instructions and are ready to comply with all study requirements with a willingness to participate and give written informed consent voluntarily.
- •Patients who had been diagnosed with mild to moderate Diabetic Neuropathic Pain.
排除标准
- •Women of child bearing potential who are either unwilling or unable to use an acceptable method of birth control to avoid pregnancy during the study period.
- •Subjects with Severe co morbid disease conditions like Heart failure, Renal Failure or Liver failure.
- •Subject with history of uncontrolled diabetes (HbA1c > 10)
- •Known allergy to compounds of investigational product.
- •Participation in an investigational drug trial in the30 days prior to the screeningvisit.
- •Patients of vulnerable group (children, lactating mother, elderly >80 years,handicapped, seriously ill, mentally challenged).
- •History of drug or alcohol abuse during the last 6 months.
结局指标
主要结局
1. Time to onset of relief of pain [ Time frame: in number of days]
时间窗: Baseline, week 4 & week 8
2. Time to achieve complete relief of pain [ Time frame: in number of days]
时间窗: Baseline, week 4 & week 8
3. VAS pain scores [ baseline, week 4 and week 8]
时间窗: Baseline, week 4 & week 8
4. Nerve conduction study of foot to assess neuropathic pain and its grading [ baseline, week 4 and week 8]
时间窗: Baseline, week 4 & week 8
5. Subject’s overall satisfaction for pain relief on a 7- point Likert
时间窗: Baseline, week 4 & week 8
Satisfaction scale[Time Frame: Baseline, week 4 and week 8]
时间窗: Baseline, week 4 & week 8
6.Number of patients requiring rescue medication [Time Frame: Up to week 8]
时间窗: Baseline, week 4 & week 8
7.Changes from base line to 8 weeks in following laboratory
时间窗: Baseline, week 4 & week 8
parameter(s):
时间窗: Baseline, week 4 & week 8
C Reactive Protein
时间窗: Baseline, week 4 & week 8
ESR
时间窗: Baseline, week 4 & week 8
Plasma level of β-Caryophyllene
时间窗: Baseline, week 4 & week 8
12. Changes from base line to 8 weeks postdose in Quality of life Questionnaires (Short Form Health-12).
时间窗: Baseline, week 4 & week 8
次要结局
- Adverse events and serious adverse events during the study period(Brief clinical examination)