"An Open Labelled Prospective Noncomparative Single Arm Clinical Study to Evaluate Safety & Efficacy of Manyawin Capsule in Patients with Cervical Spondylosis"
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Treatment-emergent adverse events (TEAEs) (serious/non-serious, expected/unexpected, related/non-related).
研究概览
简要总结
Cervical spondylosis (CS) is a muscular condition or similarly known as osteoarthritis of the spine.It often causes nerve root or spinal compression pains. This can be triggered off by a traumatic experience such as a whiplash injury, old fractures, muscle tension, or by a herniated disc or blood disease. Often, spondylosis specifically affects the facet joints in the spine CS is a chronic degenerative disease which results from progressive biomechanical stress and strain and can present as myelopathy, radiculopathy, axial cervical pain or the combination of the above. However, a proportion of patients having CS can complain about varying degrees of symptoms like vertigo, tinnitus, blurred vision, headache, nausea, vomiting, palpitations, hypertension and gastrointestinal (GI) discomfort Sida cordifolia, is one of the major ingredient of Manyawin capsule. Their roots has shown anti-inflammatory, anti-arthritic and anti-analgesic effect that found to be effective in reducing the symptoms of CS Gossypium herbaceum, is an another major ingredient of the study product. The leaf of this plant was screened and proved to be effective as anti inflammatory and anti-analgesic. Sida cordifolia and gossypium herbaceum being the major ingredients, the study product is expected to treat neck pain associated with CS and its symptoms
Total 30 Eligible patients will be enrolled in single arm 180 days for treatment and another 30 days for follow up
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •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.
排除标准
- •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;.
结局指标
主要结局
Treatment-emergent adverse events (TEAEs) (serious/non-serious, expected/unexpected, related/non-related).
时间窗: Day 01, Day 60, Day 120, Day 180, Day 210.
次要结局
- 1) Change in Visual Analogue Scale (VAS) score for neck pain, neck stiffness, radiating pain towards shoulders /arms, tingling(sensation of fingers, headache/vertigo)