Development and evaluation of Shalmali pushpa (Bombax ceiba L.) granules in the management of Asthikshaya (osteopenia) in postmenopausal women: An Exploratory clinical study.
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- 1.To develop a standardized dosage form (granules) of Shalmali pushpa
研究概览
简要总结
This exploratory clinical study is designed to develop and evaluate Shalmali Pushpa (Bombax ceiba L.) granules for the management of Asthikshaya (osteopenia) in postmenopausal women. Twenty four participants between 45 to 65 years of age with a BMD T score of –1 to –2.5 will receive 10 g of the granules twice daily for 90 days followed by a 30 day post treatment follow up.The study aims to provide a safe and effective herbal intervention that integrates traditional Rasayana principles with modern diagnostic evaluation for postmenopausal bone health.
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
- 45.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- Female
入选标准
- •1.Female subjects between age group of 45-65 years irrespective of caste and religion.
- •2.Patients having BMD score between -1 to -2.5 with clinical features of asthikshaya.
- •3.Those subjects who will be ready to sign informed consent form.
- •4.Subjects who are not taking any type of Calcium supplementation for more than 6 months.
排除标准
- •1.Subjects not willing for trial & follow up 2.Patients having BMD score between -2.5 to -3.0 (Osteoporosis) and -3 and lower (Severe osteoporosis) 3.Hyper or Hypothyroidism 4.Subjects on Multi-vitamin or calcium supplementation 5.Patients having any systemic disease or history of chronic diseases such as diabetes mellitus, tuberculosis, cancer and autoimmune diseases 6.Subjects with acute and chronic infections, Mal-absorption syndrome and Inborn errors of metabolism 7.Patients who have completed participation in any other clinical trial during the past 2 months
- •Patient receiving HRT.
结局指标
主要结局
1.To develop a standardized dosage form (granules) of Shalmali pushpa
时间窗: Baseline, 30 days, 60 days, 90 days,120 days
2.To assess the improvement in BMD score and serum calcium levels
时间窗: Baseline, 30 days, 60 days, 90 days,120 days
次要结局
- 1.Development of a preliminary analytical profile of Shalmali pushpa granules.(Baseline, 30 days, 60 days, 90 days,120 days)
研究者
Dr Aarti Raghav
All India Institute Of Ayurveda