A clinical study to evaluate the therapeutic efficacy of THENGAAI THURUVAL OTTRADAM [External Therapy] in the management of 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
- Improvement in lab parameters and relief of clinical symptoms
研究概览
简要总结
The study is A Clinical study to evaluate the therapeutic efficacy of THENGAAI THURUVAL OTTRADAM in the management of cegana vatham (cervical spondylosis). The trial will be given externally as a ottradam therapy for 48 days in 40 patients. The trial period of 12 months will be carrying out in government Siddha medical college and hospital, Palayamkottai Tirunelveli TamilNadu. Primary outcome is improvement in lab parameters and relief of clinical symptoms. The secondary outcome is reduction in restriction of movements and evaluate the effect of ottradam. In case of any adverse event (AE) is noticed and it will be referred to pharmacovigilance department of SCRI. Further management of patient will be given in OPD facility.
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
- 25.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Neck pain Radiating pain to upper limbs With or without numbness in the upper limbs Giddiness and neck stiffness Patients who are willing to give blood samples for laboratory investigation Patients who are willing to take X-ray before and after treatment Willing for admission in IPD for 48 days or willing to attend OPD regularly Patients who are willing to participate in this study with knowledge of potential risks and who are willing to sign the informed consent.
排除标准
- •Cardiac disease Tuberculosis in spine Spina bifida Use of narcotic drugs Pregnant women and lactating mother Trauma, Fracture, Ligament injury Patient with any other serious illness.
- •Benign and malignant neoplasm Congenital spinal anomalies Dermatological issues.
结局指标
主要结局
Improvement in lab parameters and relief of clinical symptoms
时间窗: 48 days
次要结局
- Reduction inrestriction of movements(To evaluate effect of ottradam)