An open single arm clinical trial to determine the therapeutic effectiveness of odivu kattum pasai in the treatment of padangaal enbu murivu (meta tarsal fracture)
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- To determine the therapeutic effectiveness of odivu kattum pasai in the treatment of Padangaal enbu murivu (Meta tarsal fracture) and assess the prognosis of padangaal enbu murivu (Meta tarsal fracture) through AOFAS scale
研究概览
简要总结
BACKGROUND:The Siddha system of medicine is one of the primitive medical systems in India. The Siddha system treats the diseases with internal & external medicines. They are as important as internal medicines in the management of health & diseases. They deal with medications & treatment procedures used both as a main stream and supportive therapy. This forms an important part of Siddha system as it ensures good effects.Bone setting is one of the specialities in siddha system of medicine. Majority of the people suffering from bone fractures are being treated successfully by this cost- effective and time-tested method.In siddha medicine, Kattu is the application of medicine made of botanicals, inorganic substances(etc).to the affected area and bandaged. Pasai is emollient and protective, but stay on the skin longer. This tenacity will have a warming effect locally. Pasai is applied on the fracture of metatarsal bone and bandaged.A fracture can be caused by either direct violence or indirect violence causes a fracture at the site of impact of the force. Indirect violence is one that is transmitted to a bone away from the site of impact producing a fracture there. Fracture of the metatarsals are due to direct violence, the foot being crushed by weighs falling on it.Stress fracture of metatarsal bone is one of the common forms of stress fracture.The fracture occurs in new recruits to the army and police due to the unaccustomed strain on the foot during training.It is also called March fracture or Fatigue fracture.Jones fracture is caused by severe inversion of the fore foot, when the foot gets doubled up with the weight falling on it.
OBJECTIVE:To determine the therapeutic effectiveness of odivu kattum pasai in the treatment of Padangaal enbu murivu (Meta tarsal fracture) and assess the prognosis of padangaal enbu murivu (Meta tarsal fracture) through AOFAS scale.
STUDY DESIGN:An open randomised clinical trial with a total of 20 diagnosed patients of Padangaal enbu murivu(Meta tarsal fracture) reporting at ayothidoss pandithar hospital national institute of siddha will be enrolled in the study.Patients having history of Open fracture,Comminuted fracture,Foot ulcers,Fracture with malunion,Uncontrolled diabetes mellitus,Hypertension,Peripheral neuritis will be excluded.The trial medicine Odivu kattum pasai as external medicine will be given for 48 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 20.00 Year(s) 至 60.00 Year(s)(—)
- 性别
- All
入选标准
- •Patient reporting with history of Meta tarsal fracture within 15 days of trauma Patients willing to undergo radiological investigation Patient willing to sign the informed consent stating that he/she will consciously stick to the treatment but can opt out of the trial of his/her own conscious discretion.
排除标准
- •Open fracture Comminuted fracture Foot ulcers Fracture with malunion Un Controlled Diabetes Mellitus K/H/O Hypertension K/H/O Peripheral Neuritis.
结局指标
主要结局
To determine the therapeutic effectiveness of odivu kattum pasai in the treatment of Padangaal enbu murivu (Meta tarsal fracture) and assess the prognosis of padangaal enbu murivu (Meta tarsal fracture) through AOFAS scale
时间窗: 48 days
次要结局
未报告次要终点
研究者
R Menaka
National institute of siddha
