Health Condition 1: G549- Nerve root and plexus disorder, unspecified
Conditions
Interventions
Intervention1: Nuflm 1
Spln 2
Rudn oil 3
: A.Nuflm 1 - capsule :500mg capsule
Dose
1 capsule (500mg) bid for patients who are less than 50 kg of body weight.
2 capsules (1gm) bid for patients who ar
Or 0.75 ml of vatha ennai
Duration: 60 Days
Rudn oil 3
External application only over the spine and limbs
Control Intervention1: NIL: NIL
Sponsors
National Institute of Siddha
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion Criteria: (For Sciatica) Males or females, ages 18 to 65, 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 through MRI, the onset of which occurred at least 3 months 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. Inclusion Criteria: (For Cervical Radiculopathy) Males or females, ages 18 to 65, able and willing to provide written informed consent to participate in the study. Pain, paresthesia or numbness in the upper-limb with cervical or periscapular pain for at least 3 months. At least one neurological sign (dermatomes, myotomes or reflexes) of an inferior motor neuron 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: Exclusion Criteria: (For Sciatica) Known or suspected serious spinal pathology (fracture; malignant, inflammatory or infective diseases of the spine; cauda equina syndrome or widespread neurological disorder). Suspected or confirmed pregnancy or less than six months post partum or planning for pregnancy. Spinal surgery greater than 12 months previously; scheduled for major surgery during the treatment or follow up period. Uncontrolled mental health condition that precludes successful participation. Inclusion Criteria: (For Cervical Radiculopathy) Males or females, ages 18 to 65, able and willing to provide written informed consent to participate in the study. Pain, paresthesia or numbness in the upper limb with cervical or periscapular pain for at least 3 months. At least one neurological sign (dermatomes, myotomes or reflexes) of an inferior motor neuron 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 degree of cervical rotation on the impaired side. Exclusion Criteria: (For Cervical Radiculopathy) Prior surgery to the cervico thoracic spine. Signs of superior motor neuron impairments (bilateral paresthesia, hyperreflexia, spasticity). 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: Baseline- Day 1 Week 3 Week 5 Week 7 Week 9 | — |
Secondary
| Measure | Time frame |
|---|---|
| Score reduction in Roland Morris Disability Questionnaire, Aberdeen Low Back Pain Scale, Oswestry Disability index, Sciatica Bothersome Index, Medical outcome study Short Form 36 physical components score, Cervical Radiculopathy Impact Scale, Patient-Specific Functional Scale, Global Perceived Effect Scale and Neck disability index score from baseline to end of the treatment. Improvement in QOL assessed through EuroQoL (5-level) EQ-5D-5L, a valid and reliable measure of generic health status. Laboratory parameters to assess the drug safety will be done before and after treatment for all the patients who receive the Nuflm-1 capsule along with Spln 2 plain/softgel and Rudn oil - For patients baseline and endpoint measurements of the above parameters will be done on the screening day and 60th day. Timepoint: Baseline- Day 1 Week 3 Week 5 Week 7 Week 9 | — |
Countries
India
Contacts
Public ContactDr M Ramamurthy
National Institute of Siddha
Outcome results
None listed