Study on Efficacy of Add on Selenium in Mild-to-moderate Graves Ophthalmopathy: A Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- To evaluate and compare the response of add on selenium in patients with grave's ophthalmopathy
研究概览
简要总结
The Study on efficacy of add on selenium in mild-to-moderate Graves ophthalmopathy: A Randomized Control Trial.; The study aims to evaluate the response of adding selenium in patients with Graves ophthalmopathy, focusing on improving quality of life, CAS scoring, and thyroid status. The methodology involves a Randomized Control Trial with a sample size of 78 patients. Patients meeting specific criteria will receive either standard treatment with Anti Thyroid Drugs and Vitamin B complex or add on selenium with Vitamin B complex for 6 months. Outcome measures include CAS score reduction, thyroid function improvement, and quality of life enhancement. The study will last 18 months, with various investigations and ethical considerations outlined. The document emphasizes the importance of early diagnosis of Graves Ophthalmopathy to prevent vision loss and deformity, highlighting the significance of informed patients and healthcare professionals regarding TED symptoms and risk factors.
详细描述
The Study on efficacy of add on selenium in mild-to-moderate Graves ophthalmopathy: A Randomized Control Trial. The study aims to evaluate the response of adding selenium in patients with Graves ophthalmopathy, focusing on improving quality of life, CAS scoring, and thyroid status. The methodology involves a Randomized Control Trial with a sample size of 78 patients. Patients meeting specific criteria will receive either standard treatment with Anti Thyroid Drugs and Vitamin B complex or add on selenium with Vitamin B complex for 6 months. Outcome measures include CAS score reduction, thyroid function improvement, and quality of life enhancement. The study will last 18 months, with various investigations and ethical considerations outlined. The document emphasizes the importance of early diagnosis of Graves Ophthalmopathy to prevent vision loss and deformity, highlighting the significance of informed patients and healthcare professionals regarding TED symptoms and risk factors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with Mild-to-moderate Grave's Ophthalmopathy in Age group >18years
- •With only one or more :
- •Retraction of lid <2 mm
- •Mild soft tissue involvement
- •Proptosis of <=3 mm
- •Corneal exposure that responds to lubricating eyedrops.
- •Patients with CAS < = 4
- •Patients diagnosed with hyperthyroidism converted to euthyroid since 2 months with Anti Thyroid Drugs.
- •Those who are willing to follow the advised treatment and timely follow ups.
排除标准
- •Treatment with any steroid (Intravenous, oral or topical) for any condition within 3 weeks before presentation.
- •Any treatment with rituximab
- •Any earlier treatment with teprotumumab.
- •Any treatment with monoclonal antibody within 3months before presentation.
- •Lactating or pregnant women
研究组 & 干预措施
ADD on Selenium
Add on Selenium (100mcg once daily) with Vitamin B Complex and Standard Treatment for Grave's Disease
干预措施: Selenium (Drug)
结局指标
主要结局
To evaluate and compare the response of add on selenium in patients with grave's ophthalmopathy
时间窗: 90 Days
To evaluate and compare the response of add on selenium in patients with grave's ophthalmopathy, with Best corrected visual Acuity, Clinical activity Score (CAS ), Increase in measured proptosis (bulging of the eyes) \> 2 mm over 1-3 months. Decrease in eye movement limit of \> 8° over 1-3 months. Decrease in visual acuity (2 Snellen chart lines) over 1-3 months. A CAS score greater than 4 is associated with active disease. The positive predictive value of CAS \> 4 is approximately 80%, and the negative predictive value is around 64%
次要结局
- the effects of Grave's ophthalmopathy on Patient's perception of their position in life in the context of the culture and value systems in which they live and in relation to their goals, expectations, standards and concerns(90 Days)
- To Assess the Colour Vison(90 Days)
- To Assess the Fundus(90 Days)
- To Examine Thyroid Function Test(90 Days)
研究者
Sandip Kumar Sahu
Associate Professor
All India Institute of Medical Sciences, Bhubaneswar