A pilot clinical trial to determine the safety and effectiveness of coded Siddha formulations Nuflm-1 capsule, Spln -2 softgel and Rudn oil -3 in the management of cervical disc disorder with radiculopathy (M50.10) and Sciatica (M54.3)
Trial Snapshot
- Phase
- Phase 2
- Status
- Suspended
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Reduction in pain intensity measured on a numerical rating scale (NRS) from base line to end of the treatment.
Study Overview
Brief Summary
Neck pain (NP) and low back pain (LBP) are common symptoms bothering people in daily life. Conventional treatments, such as medications and surgery, have demonstrated some efficacy. Nonetheless, these treatments were not always effective, and even had some serious adverse effects. Consequently, to find some more effective therapeutic methods, many individuals have turned their attention to some other treatments, such as complementary and alternative medicine. This pilot study involving 10 participants, is put forward to assess the efficacy of proposed orally administered Siddha proprietary medicine combinations such as Nuflm-1 capsule, Spln – 2 softgel and external Rudn oil – 3 in the management of cervical and lumbosacral neuralgia. The drugs contained in the proposed proprietary formulation medicine Nuflm-1 capsule includes Amukkura churanam, Thiripala churanam, Pirandai uppu, Panchapadana chenduram, Arumuga chenduram, Thamira (Sembu) parpam and Sangu Parpam. All the components have property of alleviating different neuralgic conditions.
Study Design
- Study Type
- Interventional
- Allocation
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
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
- •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.
Outcomes
Primary Outcomes
Reduction in pain intensity measured on a numerical rating scale (NRS) from base line to end of the treatment.
Time Frame: 48 days
Secondary Outcomes
- 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)
Investigators
Prof Dr G J Christian
National Institute of Siddha