Health Condition 1: G55- Nerve root and plexus compressionsin diseases classified elsewhere
Conditions
Interventions
Intervention1: Nuflm-1 capsule Spln – 2 softgel Rudn oil – 3: Nuflm-1 capsule 500mg capsule twice a day for 24 days Spln – 2 softgel 2 caps thrice a day for 48 days Rudn oil – 3 external application
Sponsors
Nil
Eligibility
Inclusion criteria
Inclusion criteria: Males or females, ages 18 to 65, are able and willing to provide written informed consent to participate in the study. Leg pain radiating to or below the knee in a dermatomal pattern, diagnosed as being due to sciatica or lumbar or lumbosacral radiculopathy, the onset of which occurred 2 to 12 weeks prior to initiation of study treatment. Leg pain severity on a screening Categorical Pain Intensity Rating (for the prior 3 days period) of at least 4 in the numerical rating scale. Leg pain should be more severe than back pain on Numerical rating scale of pain at screening. Positive straight leg raising (SLR) test. Pain, paresthesia or numbness in the upper-limb with cervical or periscapular pain for less than 3 months. At least one neurological sign (dermatomes, myotomes or reflexes) of an inferior motoneuron lesion to the upper-limb. Positive responses to at least 3 of the 4 following clinical tests: Spurling Test, Upper Limb Tension Test, Cervical Distraction Test, and less than 60° of cervical rotation on the impaired side.
Exclusion criteria
Exclusion criteria: Known or suspected serious spinal pathology. Prior surgery to the cervico - thoracic spine. Signs of superior motor neuron impairments. Cervical spine injection in the previous four weeks. Current use of steroidal anti-inflammatory drugs.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction in pain intensity measured on a numerical rating scale (NRS) from base line to end of the treatment.Timepoint: 48 days | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Score reduction in Roland Morris Disability Questionnaire, Aberdeen Low Back Pain Scale and neck disability index score from baseline to end of the treatment. 2. Improvement in QOL assessed through EuroQoL (5-level) EQ-5D-5L, a valid and reliable measure of generic health status 3. Laboratory parameters to assess the drug safety will be done weekly for two patients who receive the Nuflm-1 capsule along with Spln – 2 softgel and Rudn oil - 3. For other 8 patients baseline and endpoint measurementsTimepoint: 48 days | — |
Countries
India
Contacts
Public ContactDr M Ramamurthy
National Institute of Siddha
Outcome results
None listed