CTRI/2024/12/077576尚未招募2 期
Pilot exploratory clinical study to evaluate the safety and efficacy of SPONDYGON P50 tablet in the management of Spondylosis
Sudhatatva Pharmacy1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年12月17日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Anticipated outcome for the pilot exploratory clinical trial of spondygen p50 in spondylosis is that will significantly reduce the pain and ease the daily activity.
研究概览
简要总结
The pilot clinical study aimed to evaluate the safety and effectiveness of Spondygon P50 tablets in managing spondylosis, a degenerative condition affecting the spine. The study likely involved group of 30 participants diagnosed with spondylosis, focusing on Measuring improvements in symptoms such as pain, mobility, and quality of life.
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
- 30.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients suffering from spondylosis from the age group of 30–70 years of either sex were selected
- •History of Spondylosis less than 5 years.
- •Patient willingly ready for informed consent.
排除标准
- •The patients who had history of uncontrolled diabetes and uncontrolled systemic arterial hypertension, severe anemia with serum hemoglobin level less than 6 percent.
- •Individuals with any congenital deformity related to spine.
- •Individuals with known allergies to ingredients of interventional drug.
- •Pregnant or breastfeeding women.
- •Recent participation in another clinical trial.
结局指标
主要结局
Anticipated outcome for the pilot exploratory clinical trial of spondygen p50 in spondylosis is that will significantly reduce the pain and ease the daily activity.
时间窗: 28 days
次要结局
- Enhance quality of life with better safety and tolaribility(28 days)
研究者
Nilima Dharkar
Dr D Y Patil college of Ayurved and Research centre Pimpri Pune
研究点 (1)
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