An open label, single centric, single arm study to evaluate the efficacy and safety of WELLPEA® for the management of chronic back pain with sciatica in adults population.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- •Reduction of pain (NRS less than 4) in atleast 50% of subjects.
研究概览
简要总结
This is an open label study. This study will be conducted in a single clinical site, Institutional Ethics committee of which, is registered with CDSCO. Study will be only initiated after receiving CTRI registration number. This study is to assess the efficacy and safety of investigational product in subjects diagnosed with chronic back pain with sciatica. . After satisfying all the inclusion/exclusion criteria they will be included in the study. On Day 0 they will be dispensed with the medication and visit plan will be provided.
Study population - 60 subjects.
Study duration - 4 weeks from baseline.
Visits - 6 visits.
Study Outcomes;
Primary outcome - Reduction of pain (NRS less than 4) in at least 50% of subject.
Secondary outcome - Change in pain using NRS and NPS, Change in ODI, Change in DN4.
Type of study- Open Label
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Adult male or female subjects (age 18-65 yrs). 2.Subjects diagnosed with chronic (lasting for atleast 3 months) lower back pain due to sciatica. 3.Radiating pain into one leg below the knee. 4.Pain score between
- •6 on Numerical rating score (NRS). 5.DN4 score more than
- •6.Able to communicate adequately with the investigator and to comply with the requirements for the entire study. 7.Patient should be able to give written informed consent prior to participating in the study.
排除标准
- •1.Any serious spinal pathology (e.g. cauda equina syndrome, spinal fracture).
- •2.Spinal surgery or interventional procedures scheduled for sciatica during the 4 week treatment period.
- •3.On a medication for neuropathic pain, a tricyclic antidepressant or a sedative and unable to cease the medication.
- •4.Subjects taking nutraceuticals containing PEA, alpha lipoic acids, botanical extracts and other functional ingredients able to reduce LBP and/or intefearing with the Endocannabinoid system.
- •5.Steroidal anti-inflammatory drugs, NSAIDs during the month prior to screening.
- •6.Any fractures as well as muscle sprain.
- •7.Concomitant diseases (i.e. cancer, kidney diseases, liver diseases, neurological diseases, diabetes, gastritis psychiatric diseases, blood disorders, gastrointestinal diseases, infections).
- •High alcohol intake (more than 2 drinks per day) or use of recreational drugs (such as cocaine, methamphetamine, marijuana etc).
- •9.Subjects with known sensitivity to any components of the investigational product.
- •10.Pregnant or breastfeeding women, and males or females planning conception during the 4 week treatment period.
- •11.Participation in concomitant interventional clinical study or during the previous 30 days.
结局指标
主要结局
•Reduction of pain (NRS less than 4) in atleast 50% of subjects.
时间窗: Screening, Week 1,2,3 & 4.
•Change in pain using NRS.
时间窗: Screening, Week 1,2,3 & 4.
•Change in pain using NPS.
时间窗: Screening, Week 1,2,3 & 4.
•Change in Daily life disability by Oswestry Disability Index (ODI).
时间窗: Screening, Week 1,2,3 & 4.
•Change in DN4.
时间窗: Screening, Week 1,2,3 & 4.
次要结局
- Physical Examination(2.Vital Signs: Pulse rate, blood pressure & body temperature)
研究者
Dr Harshith N
Rajalakshmi Hospital and Research Center