To study the effect of statins on Graves orbitopathy in patients with Graves disease presenting to a tertiary care hospital in Western Maharashtra
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- 1. Improvement in clinical activity score
研究概览
简要总结
A total of 150 patients diagnosed with Graves’ disease will be enrolled in the study. These 150 patients are then randomly selected and randomised into two equal groups using computer generated random number sequence-The Control group and the Treatment group. All the 150 patients will undergo a baseline clinical examination, laboratory investigations, eye examination and their 7 point Clinical activity score will be calculated. The control group will receive only the standard of care treatment whereas the treatment group will be administered 20mg of Atorvastatin once daily at night for a duration of 6 months in addition to the standard of care treatment. All patients will undergo comprehensive ophthalmologic evaluations to assess features of Graves’ orbitopathy, baseline laboratory investigations and their 10 point Clinical activity score will be calculated at 3months and 6months. Subsequently, the collected data will be analysed to determine the impact of statin therapy on patients with Graves disease.
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 80.00 Year(s)(—)
- 性别
- All
入选标准
- •Confirmed diagnosis of graves disease
- •Willingness to give consent.
排除标准
- •Previous treatment with statins within the past 6 months.
- •Contraindications to statin therapy.
- •Pregnancy or lactation.
- •Patients who did not provide informed consent.
结局指标
主要结局
1. Improvement in clinical activity score
时间窗: 6 months post initiation of statin therapy
次要结局
- 2.Changes in CBC, LFTs, and RFTs from baseline, particularly focusing on any adverse effects related to statin therapy.(6 months post initiation of statin therapy)
研究者
Aswin Babu N
Armed Forces Medical College
