A randomized controlled clinical trial to evaluate the effect of Trayodashanga Guggulu in the management of Osteopenia (Asthimajja kshaya)
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Improvement in T score and Reduction of signs and symptoms
研究概览
简要总结
Osteopenia is a clinical term used to describe a decrease in bone mineral density, yet not low enough to meet the diagnostic criteria to be considered Osteoporotic1. Osteopenia, as defined by the World Health Organization (WHO), is a t-score between -1 to -2.5, while values less than -2.5 are diagnostic for Osteopenia.
Decreasing BMD values are reflective of an underlying disruption in the micro architecture of bone and Osteopenia, and Osteoporosis is considered quantitative, not qualitative, disorders of bone mineralization.
The natural bone loss that occurs gradually during adulthood is considered to be the cause of primary form of Osteopenia and secondary form of Osteoporosis. Secondary causes serve to accelerate this process and include lifestyle factors such as alcohol use disorder, smoking, sedentary lifestyle, thin body habitus (BMI under 18.5 kg/m2)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 40.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •1.T Score with -1 to -2.5
- •Clinical features of Osteopenia like Extreme fatigue, Body pain, Pain in back, vertebra , hip,distal forearm , tibia or any history of fracture or Minimal trauma.
排除标准
- •patients below the age 40 years and above 70 years, and pre diagnosed with Pathological osteopenia and Osteosarcoma , Hypercalcemia.
结局指标
主要结局
Improvement in T score and Reduction of signs and symptoms
时间窗: 91th days
次要结局
未报告次要终点
研究者
Dr Udit Saxena
Sri Jayendra Saraswathi Ayurveda College and Hospital, Nazarathpet, Chennai.