Health Condition 1: M543- Sciatica
Conditions
Interventions
None listed
Sponsors
ALNA BIOTECH PVT. LTD.
Eligibility
Inclusion criteria
Inclusion criteria: Subjects who meet all of the following criteria will be included in the study: 1)Adult male and female subjects aged 18-60 years. 2)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. 3)Duration of pain must be at least 1 week and up to 6 months. 4)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. 5)Ability and willingness to provide written informed consent. 6)Able to read and understand the local language used for study-related communication and materials.
Exclusion criteria
Exclusion criteria: 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). 2)Sciatica due to causes other than disc herniation or degenerative spinal stenosis. 3)Symptoms suggesting immediate need for surgery, including progressive large paresis or cauda equina syndrome. 4)Presence of neurogenic claudication (leg pain upon walking/standing relieved by sitting/lumbar flexion). 5)Scheduled or planned spinal surgery during the study period. 6)History of pregnancy, attempting to conceive, currently pregnant, or breastfeeding. 7)Subjects with liver or renal impairment, congestive heart failure, ischemic heart disease, peripheral arterial disease, or cerebrovascular disease. 8)Subjects with a history of peptic ulceration, gastrointestinal bleeding, or perforation. 9)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. 10)Use of diuretics, ACE inhibitors, or lithium. 11)Ongoing psychiatric illness, drug or alcohol abuse, or any condition that may interfere with adherence to the study protocol or follow-up. 12)Known hypersensitivity to any ingredient of the NERVE SANJEEVANI Capsule. 13)Non-compliance or inability to follow the study protocol, as judged by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in sciatica pain intensity (in the last 24 h) assessed by the Numeric Rating Scale (NRS) score from baseline to different study visitsTimepoint: Day-1 (Screening visit) Day-14 (End of visit) | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in Disability, assessed by the Roland Morris Disability Questionnaire for Sciatica (RMDQ-S) from baseline and end of treatment. Change in Sciatica symptom severity, assessed by the Sciatica Bothersomeness Index (SBI) from baseline to end of visits. Rescue medication consumption, measured by pill count, i.e., the number of paracetamol pills not returned at the final study visit. Change in Global perceived change (GPC), measured on a verbal rating scale: sciatica/back problem completely gone , much better , better , a little better , no change , a little worse , worse , or much worse . Change in Health-Related Quality of Life (HRQOL) using the SF-36 Score.Timepoint: Day-1 (Screening visit) Day-14 (End of visit) | — |
Countries
India
Contacts
Public ContactMr Hasan Ali Ahmed
ALNA BIOTECH PVT. LTD.
Outcome results
None listed