An open labelled double arm non randomized phase-II clinical trial to evaluate the therapeutic efficacy of PIRANPAN KIZHANGU CHOORNAM (INTERNAL) ILAGU VIDA MUTTI THYLAM (EXTERNAL) AND THOKKANAM (PIDITHAL MURAI EXTERNAL THERAPY) in the management of THANDAGA VATHAM (LUMBAR SPONDYLOSIS)
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Assessment of changes from baseline in universal pain assessment scale score at day 48 between Group I (Thokkanam External therapy) and Group II (Medicine and Thokkanam External therapy)
Study Overview
Brief Summary
Lumbar spondylosis is a degenerative changes in disc and lumbar spine. Disc degeneration is age related and starts in the 3rd decade.
Reduction in the molecular size of the proteoglycans of the Nucleus Pulposus is associated with loss of viscol elastic properties, increased load bearing by the annulus is followed by focal damage and disc herniation in some cases. Disc prolapse and osteophytosis can formed root compression and indirect ischemic neuronal damage.
Thokkanam signifies a group of therapeutic procedures, usually done with hand on the body in nine different ways, with or without the application of medicated oil (Thailam). These procedures can either be curative or palliative. Normally Thokkanam is done for diseases in which Vaatham is the mostly deranged.
Study Design
- Study Type
- Interventional
- Allocation
- Not Applicable
- Masking
- Open Label
Eligibility Criteria
- Ages
- 20.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Patients having symptoms of Pain in the lumbar region, Radiating pain to buttocks and lower limbs, stiffness present in lumbar region, Exacerbation of pain on movements, Pain increased on forward bending, Tingling sensation.(Numbness) Patients who are willing to give radiological investigation and provide blood for lab investigation.
- •Patient willing to sign the informed consent stating that he/she will conscientiously stick to the treatment during 48 days but can option out of the trial of his/her own conscious discretion.
Exclusion Criteria
- •Cardiac disease Auto immune diseases like Rheumatoid arthiritis, SLE, Psoriasis, Mixed connective tissue disorder.
- •Spina bifida Osteo myelitis Renal Disease Tuberculosis in spine Patient with any other serious illness Other systemic illness Dislocation.
Outcomes
Primary Outcomes
Assessment of changes from baseline in universal pain assessment scale score at day 48 between Group I (Thokkanam External therapy) and Group II (Medicine and Thokkanam External therapy)
Time Frame: 48 Days
Comparison of efficacy in patient Group I and Group II
Time Frame: 48 Days
Secondary Outcomes
- Assessment of quality of life by universal pain score scale(Assessment of safety parameters)