CTRI/2025/04/084167
尚未招募
不适用
Safety and efficacy of twice daily versus thrice daily hydrocortisone regimen in glucocorticoid induced Adrenal Insufficiency patients: A Randomized Control Trial
Dr Prince Rastogi1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年4月14日最近更新:
概览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- Dr Prince Rastogi
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- 1.To compare cortisol day curve AUC at 4 weeks and 12 weeks which align with Physiological day curve AUC of normal healthy controls.
概览
简要总结
This study will help in selecting better regimen based on safety and efficacy of hydrocortisone in glucocorticoid induced adrenal insufficiency patients. So with this study, we expect to see improvement in morbidity associated with over or under treatment with hydrocortisone therapy.
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 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Age 18 years and above
- •Both Male and Female
- •Diagnosed with GIAI
- •Deemed to be started on hydrocortisone replacement therapy.
排除标准
- •Adrenal insufficiency patients other than GIAI were excluded
- •Pregnant and lactating females
- •Patients on combined oral contraceptive pills or opioids
- •Patients on anti-epileptic medications or current ATT intake
- •Patients of CKD (eGFR lesser than 60 ml/min/1.73 m2 or serum creatinine greater than 1.5 mg/dL)
- •Hepatic dysfunction with ALT or AST greater than 3x ULN
- •History of any systemic infection in last 4 weeks
- •History of pituitary disease.
结局指标
主要结局
1.To compare cortisol day curve AUC at 4 weeks and 12 weeks which align with Physiological day curve AUC of normal healthy controls.
时间窗: Baseline visit at week 1 | 2nd visit at week 4th | 3rd visit at week 12th
次要结局
- 1. To assess glycemic status HBA1c, FBS in the patients at baseline, 4 weeks and 12 weeks and 24 hour urine free cortisol in the patients at 4 and 12 weeks.(2. To compare the body weight, waist circumference, body composition parameters at baseline, 4 weeks and at 12 weeks .)
研究者
Dr Prince Rastogi
AIIMS JODHPUR
研究点 (1)
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