CTRI/2024/07/069866尚未招募2 期
Open label randomised controlled trial of telmisartan in Raynauds phenomena associated with progressive systemic sclerosis and mixed connective tissue disorder
Institute of Medical Sciences Banaras Hindu University Varanasi Uttar Pradesh 2210051 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2024年11月1日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Improvement in severity and frequency of Raynauds
研究概览
简要总结
Registered cases will randomised into 2 groups of 10 patients each, all patients will receive standard of care ( Tadalafil with cold protective measures), one arm of the study (10patients) will receive Telmisartan (20- 40mg) and the other group will receive Nifedipine (10 - 20mg) from the month of November to February, they will be then followed up at 6 and 12 weeks with Raynauds condtion score which will assess the frequency and severity of Raynauds Phenomenon
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
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Age greater than or equal to 18 years 2.Patients diagnosed as systemic sclerosis or MCTD with history of Raynauds Phenomena 3.Willing to give signed written consent.
排除标准
- •1.Any co-existing significant/incapacitating chronic illness 2.Patient with symptomatic CAD 3.Patients on oral or sublingual nitrates 4.Patient who are pregnant or reproductive couples who have intention of pregnancy 5.Patients with known contraindication to either of IPs or SOC Patient with symptomatic CAD.
结局指标
主要结局
Improvement in severity and frequency of Raynauds
时间窗: 0,6 and 12 weeks
Phenomenon after introduction of drug with
时间窗: 0,6 and 12 weeks
standard of care
时间窗: 0,6 and 12 weeks
次要结局
- Any untoward effect or hypersensitivity(At 1 & 2 weeks)
研究者
Suraj Kumar Sha
Institute of Medical Sciences
研究点 (1)
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