Health Condition 1: M478- Other spondylosis
Conditions
Interventions
None listed
Sponsors
SKM Siddha and Ayurveda Company India Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1) Male/female patients aged = 18 years and = 65 years at the time of consent; 2) Patients with clinically confirmed diagnosis of cervical spondylosis within the last 6 months; 3) Patients who have had one or more episodes of neck pain, neck stiffness attack on average per month for more than 3 months; 4) Patients with NDI score of 20-35 at the time of screening; 5) Patients with VAS score of >5 at the time of screening; 6) Patients displaying a minimum of three of the following symptoms as evaluated by the physician: a) Cervical pain aggravated by the movement; b) Pain in occiput (back of the head), shoulder blades or upper limbs; c) Retro-orbital or temporal pain; d) Cervical stiffness; e) Localized tenderness, pain or numbness of upper limbs f) Dizziness or vertigo attributed to cervical pain; 7) Patients who are willing to give voluntary written informed consent.
Exclusion criteria
Exclusion criteria: 1) Patients with known or suspected allergies/hypersensitivities to herbal or ayurvedic medicines; 2) Patients who are clinically diagnosed with osteoarthritis, rheumatoid arthritis and ankylosing spondylitis; 3) Patients with known history or diagnosis of advanced cervical radiculopathy, bony spurs, cervical myelopathy, cervical malignancies and lesions; 4) Patients with severe congenital malformation of cervical vertebra; known history of cervical injury, cervical surgery, and implanted instrumentation; 5) Patients with history of major neurological disorder such as a stroke, myasthenia gravis, muscular dystrophy, myotonic dystrophy and sclerosis; 6) Patients with traumatic soft tissue injury to the cervical region in the past 1 year; 7) Patients who are known to be asthmatic or immunocompromised; 8) Patients who are on NSAIDs, DMARDs or any other treatments for cervical pain for 1 month before screening; 9) Patients with terminally ill and any other condition, in the opinion of the investigator, which would affect the safety of the patient; 10) Female patients who are breast-feeding/ pregnant, or intends to become pregnant during the study;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Treatment-emergent adverse events (TEAEs) (serious/non-serious, expected/unexpected, related/non-related).Timepoint: Day 01, Day 60, Day 120, Day 180, Day 210. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Change in Visual Analogue Scale (VAS) score for neck pain, neck stiffness, radiating pain towards shoulders /arms, tingling sensation of fingers, headache/vertigo 2) Change in Neck Disability Index (NDI) Score 3) Change in Short-form McGill Pain Questionnaire (SF-MPQ) 4) Quality of life Questionnaire SF-36Timepoint: Day 1, Day 60, Day 120, Day 180, Day 210. | — |
Countries
India
Contacts
Public ContactBrindha Arumugam
SKM Siddha and Ayurveda Company India Private Limited
Outcome results
None listed