A Non-randomized, Open-labelled, Clinical Study to Evaluate the Efficacy and Safety of NERVE SANJEEVANI Ayurvedic Capsule in Patients with Sciatica Pain
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change in sciatica pain intensity (in the last 24 h) assessed by the Numeric Rating Scale (NRS) score from baseline to different study visits
研究概览
简要总结
Sciatica, characterized by radiating pain along the sciatic nerve pathway from the lower back into the leg, is a prevalent and debilitating condition often caused by lumbar disc herniation or spinal stenosis.Sciatica pain, often persistent and resistant to conventional therapies, significantly affects patients’ quality of life and functional ability. While pharmacological management including NSAIDs, corticosteroids, and surgical interventions are standard approaches, these options are often associated with limited long-term efficacy or adverse effects.
The dosage of NERVE SANJEEVANI Capsule (650 mg twice daily) has been selected based on authoritative Ayurvedic texts and traditional clinical practice.
Primary Objective: To evaluate the clinical efficacy of NERVE SANJEEVANI Capsule in reducing sciatica pain intensity using the Numerical Pain Rating Scale.
Secondary Objectives The secondary objectives of this study are to: 1.Improvement in disability 2) Global perceived improvement 3) Improvement in sciatica symptom severity 4) Use of rescue medication (paracetamol) consumption 5) Safety and tolerability of NERVE SANJEEVANI Capsule
The treatment continues for a period of 14 days (2 weeks). The total duration of the study is 6 months.
A total of 50 adult subjects will be enrolled in the study group (NERVE SANJEEVANI Capsule) based on practical feasibility, clinical judgment, and prior experience with similar studies. The chosen sample size is considered adequate to provide preliminary insights into the efficacy and safety profile of the investigational product in patients with sciatica pain.
The schedule of assessment for this study spans a duration of 14 days (2 weeks) and comprises three visits: the screening visit & baseline visit (V1), and end-of-study visit (V2).
Baseline and End of visit evaluations will include the Numeric Rating Scale (NRS) for pain, the Roland Morris Disability Questionnaire for Sciatica (RMDQ-S), the Sciatica Bothersomeness Index (SBI), Global Perceived Change (GPC) and the Short Form-36 (SF-36) health-related quality of life questionnaire. Blood samples will be collected for safety laboratory tests including complete blood count (CBC), SGPT, SGOT, Serum creatinine and Random blood sugar levels.
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 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects who meet all of the following criteria will be included in the study: 1)Adult male and female subjects aged 18-60 years.
- •Radiating pain into one leg below the knee, with a pain severity score of greater than 4 on a 0–10 Numeric Rating Scale (NRS) within the previous 24 hours.
- •Duration of pain must be at least 1 week and up to 6 months.
- •Presence of nerve root/spinal nerve involvement as indicated by at least one of the following: a.Myotomal weakness.
- •b.Dermatomal sensory disturbances (e.g., tingling, numbness, sensory loss).
- •c.Diminished reflexes.
- •d.Leg pain radiating in a dermatomal distribution or exacerbated by a positive straight leg raise (SLR) test.
- •Able to read and understand the local language used for study-related communication and materials.
排除标准
- •Participants will be excluded from the study if they meet any of the following conditions: 1)Known or suspected serious spinal pathology (e.g., cauda equina syndrome, spinal fracture).
- •Sciatica due to causes other than disc herniation or degenerative spinal stenosis.
- •Symptoms suggesting immediate need for surgery, including progressive large paresis or cauda equina syndrome.
- •Presence of neurogenic claudication (leg pain upon walking/standing relieved by sitting/lumbar flexion).
- •Scheduled or planned spinal surgery during the study period.
- •History of pregnancy, attempting to conceive, currently pregnant, or breastfeeding.
- •Subjects with liver or renal impairment, congestive heart failure, ischemic heart disease, peripheral arterial disease, or cerebrovascular disease.
- •Subjects with a history of peptic ulceration, gastrointestinal bleeding, or perforation.
- •Use of medications (e.g., Anticoagulants, Aspirin, NSAIDs Selective Serotonin Reuptake Inhibitors, Systemic corticosteroids), food or herbal supplements within 30 days from the date of screening.
- •Use of diuretics, ACE inhibitors, or lithium.
- •Ongoing psychiatric illness, drug or alcohol abuse, or any condition that may interfere with adherence to the study protocol or follow-up.
- •Known hypersensitivity to any ingredient of the NERVE SANJEEVANI Capsule.
- •Non-compliance or inability to follow the study protocol, as judged by the investigator.
结局指标
主要结局
Change in sciatica pain intensity (in the last 24 h) assessed by the Numeric Rating Scale (NRS) score from baseline to different study visits
时间窗: Day-1 (Screening visit) | Day-14 (End of visit)
次要结局
- Change in Disability, assessed by the Roland Morris(Disability Questionnaire for Sciatica (RMDQ-S) from)
研究者
Dr Lokesh Holagundi
Health India Hospital