A Comparative clinical study to validate the influence of Gandha taila and Ksheerabala taila 101 on Osteopenia and Osteoporosis using biochemical markers of bone formation and resorption.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Reduction in Bone resorption markers and increase in Bone formation markers
研究概览
简要总结
Osteoporosis is the second most common metabolic bone disease. Osteoporosis constitutes a major public health problem, on an average 25 million Indians are affected. Asthikshaya, which can be paralleled to osteopenia, further leads to Asthisaushirya i.e porous bones.
Deterioration in the quantity & quality of bone mass are brought by an imbalance between bone resorption and bone formation processes that are normally coupled and is called as bone turnover. Markers of this bone turnover (BTM) have a variety of potential clinical applications based on their rapid response to treatment, their value in monitoring compliance to medications.
Establishing an Ayurvedic formulation which can arrest the pathology & effectively improve the bone mass without any adverse effects, is the need of the hour, as increase in the incidence of osteoporosis has gained the national priority for medical research in AYUSH.
In order to develop evidence-based practice, a randomised open label, comparative, interventional clinical study is proposed. Here the formulation ‘Gandha Taila’ will be given orally in the dosage of 1ml twice daily with warm water 30 minutes before food for a period of 120 days for 21 subjects of osteopenia or osteoporosis of both the groups A and B. Its efficacy will be assessed through 4 biochemical markers of bone formation & 5 markers of bone resorption in serum. As it validates the mode of action of both Gandha Taila,and Ksheerabala taila 101, this work will be highly useful for the clinical practise.As the trail also includes drug safety study among the subjects, which will further help in the overall improvement in patient care.
In this regard, it is a novel project in this field for evidence based medical practice as it will throw light on understanding the pharmacological action of drug ‘Gandha taila’ and Ksheerabala taila 101 over pathophysiology of osteoporosis which will be helpful in planning the treatment of osteoporosis.
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
- 35.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •1 Subjects having BMD t score less than or equal to minus 1 2 Clinical features of osteopenia and osteoporosis that is skeletal pain tenderness fracture and that of asthikshaya like asthi shula sandhishaithilya keshapaata and shrama 3 Subjects of either gender above 35 years of age.
- •4 Women irrespective of their menopausal status.
- •5 Subjects irrespective of vegetarian and non-vegetarian diet pattern.
排除标准
- •1 Subjects in whom orally taila is contraindicated.
- •2 Subjects under corticosteroids and other interfering drugs 3 Pregnant and lactating women.
结局指标
主要结局
Reduction in Bone resorption markers and increase in Bone formation markers
时间窗: At the end of the study after 120 days
次要结局
- safety profiling of Gandha taila & Ksheerabala taila 101 on Liver & Kidney functions using specific Biochemical markers like CBC, SGOT, SGPT, Urea, Creatinine(60 days & 120 days)
研究者
DR VEENA G RAO
JSS Ayurvda Medical College and Hospital Lalithadripura road Mysore