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.
Overview
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
- Dr Deepan K
- Enrollment
- 96
- Locations
- 1
- Primary Endpoint
- 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.
Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 70.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
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.
Time Frame: Comparison of change in reduction in duration of fever compared to standard therapy
Secondary Outcomes
- 1. To evaluate the duration of hospital stay(2. Subjective self-assessment by the patient)
Investigators
Deepan K
Sri Ramachandra Medical College and Research Institute