Non randomized, open label clinical study to evaluate efficacy of Dalzbone capsules in fracture healing of long bone fracture of leg
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Fracture union confirmed by radiological assessment
研究概览
简要总结
This is an open label, non randomized, single arm clinical trial. This trial is aimed to evaluate efficacy of Dalzbone capsule in healing of long bone fractures of leg. Total 20 patients with long bone fracture of leg will be recruited in this trial within 0-5 days of internal or external fixation of their fractures. Patients will be given one capsule of Dalzbone three times in a day for 2 months. Dalzbone is FDA approved single herb extract from Pharmanza Herbal Pvt. Ltd. Each capsule of Dalzbone contains 200mg of Dalbergia sissoo(Shisham) leaf extract. The clinical and radiological assessment of the patients will be done at baseline, 4th week, 6th week and 8th week. The data will be recorded and used for publication.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Radiologically diagnosed traumatic, simple as well as closed long bone fracture of Arms and leg.
- •Fractures with internal fixation.
- •Willing to give inform consent.
- •0-5 days from the incident of fracture.
排除标准
- •Pathological fracture.
- •Fracture patients with diabetes.
- •Pregnant and breast feeding women.
- •History of allergy to herbal medicines.
结局指标
主要结局
Fracture union confirmed by radiological assessment
时间窗: at baseline after four week after six week and after eight week
次要结局
- Restoration of functional motility confirmed by clinical assessment(at baseline after four week after six week and after eight week)