A randomized single blind, placebo control clinical study to evaluate the efficacy of Dalbergia sissoo extract (Dalzbone capsule) in healing of diaphyseal fracture of femur
试验速览
- 阶段
- Phase 3 4
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 1. Restoration of functional motility confirmed by clinical assessment.
研究概览
简要总结
This study is to evaluate efficacy of Dalbergia sissoo standardized extract in accelerating healing of diaphyseal fracture of femur. This study is expected to benefit the fracture patients in terms of reducing their morbidity, decreasing the period of immobilization and suffering, hastening the recovery process, leading to the early weight bearing, mobility, ambulation and return to the normal health.
60 subjects will be divided into 2 groups (30 subjects/ group), one group will receive Dalbergia sissoo extract capsules (one capsule twice a day) and another group will receive placebo capsules ( one capsule twice a day). the trial medicines will be given to patient with their ongoing standard treatment for fracture. Patient has to visit study site from the screening visit to the end of study at the interval of O week, 2 week, 6 week, 12 week, 16 week and 24 week and undergo clinical, radiological and hematological evaluation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 40.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Radiologically diagnosed traumatic diaphyseal fracture of femur bone indifferent of compound, comminuted, closed or open fracture with surgical intervention.
- •Willing to give informed consent.
- •0-5 days from the incident of fracture.
排除标准
- •Pathological fracture.
- •Fracture patients with uncontrolled HTN(Blood Pressure ≥140 mmHg or an average Diastolic Blood Pressure ≥90 mmHg among those with HTN) or diabetes (Blood Glucose Level> 200 and Fasting Blood Glucose Level> 125 among those with diabetes)
- •Fracture in smokers.
- •Pregnant and breast feeding women.
- •History of allergy to herbal medicines.
- •Patient with renal failure, liver failure and or cardiac failure.
结局指标
主要结局
1. Restoration of functional motility confirmed by clinical assessment.
时间窗: 0 week, 2 week, 6 week, 12 week, 16 week and 24 week.
2. Radiological healing and biochemical marker analysis
时间窗: 0 week, 2 week, 6 week, 12 week, 16 week and 24 week.
次要结局
- Radiological healing and biochemical marker analysis(0 week, 2 week, 6 week, 12 week, 16 week and 24 week.)