CTRI/2024/06/068953尚未招募Phase 3 4
A clinical study to evaluate the efficacy of a traditionally found calcium rich food supplement (laddu) in the management of asthi shosh (osteoporosis) caused due to calcium deficiency.
Post Graduate Institute of Ayurveda1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年8月1日最近更新:
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Increase in Bone mineral density
研究概览
简要总结
An interventional study will be done on 50 patients with administration of a traditionally found calcium rich food supplement (laddu) for 45 days. The patients will be assessed on the basis of subjective and objective criteria for asthi shosh before and after trial. Follow up will done every 15th day. The data will be collected and analyzed statistically using appropriate tests.
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
- 40.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Willingness and able to participate for 45 days.
- •Lactating mothers falling under the age group criteria.
- •T-score of BMD test -1 to -2.5 (osteopenia) and -2.5 and below (osteoporosis).
- •Classical symptoms of Asthi Sosha.
排除标准
- •Patients below 40 years of age of both sexes.
- •T-score of BMD test –1 & above or –2.5 & below with bone fracture.
- •Juvenile Osteoporosis or Malabsorption syndrome.
- •Menopausal women with H.R.T. Hypo or Hyperparathyroidism, Hypo or Hyperthyroidism.
- •Patient with history of fragility fracture and long bone fracture.
- •Patient under any drug which is known to affect bone metabolism.
结局指标
主要结局
Increase in Bone mineral density
时间窗: 45 Days
次要结局
- Decrease in Symptoms of Asthi shosh -
研究者
Dr Swapnil Jaiswal
Post Graduate Institute of Ayurveda, Dr. Sarvepalli Radhakrishnan Ayurved University
研究点 (1)
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