A Prospective, Randomized, Open-label trial to study the efficacy and safety of amino acids infusion as an add-on therapy in patients with dengue fever.
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- To study the efficacy of amino acids ampoules infusion when given along with standard therapy in patients with dengue fever in reducing the duration of fever and complications.
研究概览
简要总结
This clinical trial, titled “A Prospective, Randomized, Open-label trial to study the efficacy and safety of amino acids infusion as an add-on therapy in patients with dengue fever,†aims to assess whether administering amino acid infusions alongside standard dengue therapy can improve recovery outcomes.
Key Points:
- Study Objectives:
• Primary: Evaluate the effectiveness of amino acid infusion in reducing the duration of fever and complications in dengue patients.
• Secondary: Assess hospital stay length, symptom relief, and subjective and physician-reported improvements.
- Methodology:
• Design: Open-label, randomized controlled trial.
• Population: 96 hospitalized dengue patients aged 18 and above without severe complications.
• Intervention: Amino acid infusion (2 ampoules/day for 3–5 days) alongside standard care (IV fluids).
• Control: Standard care alone.
- Endpoints:
• Primary: Reduction in fever duration.
• Secondary: Improvements in hospital stay duration, symptom relief, and platelet count changes.
- Significance:
• Dengue has no specific antiviral treatment, and supportive care is critical.
• Amino acids could enhance protein balance, boost immunity, and aid recovery.
- Safety:
• Risks include mild infusion-site discomfort and rare allergic reactions.
• Patients are monitored for adverse events throughout the trial.
This study aims to provide evidence on the role of amino acids as a supportive therapy in dengue, potentially optimizing patient care and reducing healthcare burden.
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 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients above 18 years of age diagnosed with dengue.
- •Adults confirmed dengue infection by positive NS1 antigen or IgM positive (ELISA Method).
- •All patients recommended for hospitalization and intravenous (IV) fluid therapy.
- •Diagnosed with Dengue fever without warning signs according to 2009 guidelines in In-Patient ward.
排除标准
- •Children below 18 years of age.
- •Adults and children with comorbid conditions associated with cardiovascular, kidney, liver, respiratory, tumour.
- •Critical dengue cases DHF with warning signs according to 2009 guidelines.
- •Patients with history of dengue vaccine in the recent past.
- •Hypersensitivity to previous amino acid infusion.
结局指标
主要结局
To study the efficacy of amino acids ampoules infusion when given along with standard therapy in patients with dengue fever in reducing the duration of fever and complications.
时间窗: Comparison of change in reduction in duration of fever compared to standard therapy
次要结局
- 1. To evaluate the duration of hospital stay(2. Subjective self-assessment by the patient)
研究者
Deepan K
Sri Ramachandra Medical College and Research Institute