An Open labelled non randomised Phase II comparative clinical trail to evaluate the therapeutic efficacy of POTTANAM (External therapy) and AAYIL PATTAI CHOORANAM (Internal) for CEGANA VATHAM (Cervical Spondylosis)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Comparison of change from baseline in Oswestry Neck Disability Index at day 48 between Group I and Group II
研究概览
简要总结
Cervical spondylosis is a common degenerative conditionof the cervical spine.It is most likely caused by age – related changes in theintervertebral discs. In Cervical spine,some degree of degenerative change is anormal radiological finding in the middle aged and elderly InAgasthiyar Attavanai Vagadam a drug AAYILPATTAI CHOORANAM has been indicated for Vatha disease.Hence I have selected this polyherbal formulation AAYILPATTAI CHOORANAM to evaluate the synergic therapeuticefficacy in the treatment of “CEGANA VATHAM†(CERVICAL SPONDYLOSIS) and also Ihave selected “POTTANAMâ€(Pouch)isone of the best external therapies in Siddhasystem in alleviating pain in CeganaVatham is also evaluated the complementarytherapy with trial medicines.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 20.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Neck pain Radiating pain to the upper limbs With or without numbness in the upper limbs Giddiness and Neck Stiffness Patient who are willing for admission and stay in IPD or willing to attend OPD Patients who are Willing to give blood samples for laboratory investigations.
排除标准
- •Cervical rib Trauma Spina bifida Ankylosing spondylosis Tuberculosis in spine Cardiac disease •Other systemic illness.
结局指标
主要结局
Comparison of change from baseline in Oswestry Neck Disability Index at day 48 between Group I and Group II
时间窗: 48 days
次要结局
- 1.Assessment of safety parameters(2.Assessment of quality of life by EQ-5D)
- Assessment of safety parameters(Assessment of quality of life by EQ-5D)