Evaluation of Siddha formulations Nuflm-1 capsule, Spln-2 softgel and Rudn oil-3 in the treatment of neck pain and backpain with sciatica.
- Conditions
- Health Condition 1: G55- Nerve root and plexus compressionsin diseases classified elsewhere
- Registration Number
- CTRI/2024/03/064253
- Lead Sponsor
- il
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Reduction in pain intensity measured on a numerical rating scale (NRS) from base line to end of the treatment.Timepoint: 48 days
- Secondary Outcome Measures
Name Time Method 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. <br/ ><br>2. Improvement in QOL assessed through EuroQoL (5-level) EQ-5D-5L, a valid and reliable measure of generic health status <br/ ><br>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