| CTRI Number |
CTRI/2024/12/078475 [Registered on: 23/12/2024] Trial Registered Prospectively |
| Last Modified On: |
28/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Evaluating the Role of Amino Acid Infusions in Faster Recovery for Dengue Patients. |
|
Scientific Title of Study
|
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. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Deepan K |
| Designation |
Junior Resident |
| Affiliation |
Sri Ramachandra Medical College and Research Institute |
| Address |
Dept of Pharmacology,
Sri Ramachandra Medical College and Research Institute,
Porur,
Chennai
Chennai
TAMIL NADU
600116
India |
| Phone |
9566499286 |
| Fax |
|
| Email |
drdeeps92@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kavitha R |
| Designation |
Professor and Head of Department |
| Affiliation |
Sri Ramachandra Medical College and Research Institute |
| Address |
Dept of Pharmacology,
Sri Ramachandra Medical College and Research Institute,
Porur,
Chennai
Chennai
TAMIL NADU
600116
India |
| Phone |
9444551410 |
| Fax |
|
| Email |
r.kavitha@sriramachandra.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Deepan K |
| Designation |
Junior Resident |
| Affiliation |
Sri Ramachandra Medical College and Research Institute |
| Address |
Dept of Pharmacology,
Sri Ramachandra Medical College and Research Institute,
Porur,
Chennai
TAMIL NADU
600116
India |
| Phone |
9566499286 |
| Fax |
|
| Email |
drdeeps92@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jhaver Research Foundation Pvt Ltd,
No 3A, R A Building,
Marshalls Road,
Egmore,
Chennai, TamilNadu,
India - 600008 |
|
|
Primary Sponsor
|
| Name |
Dr Deepan K |
| Address |
Junior Resident,
Dept of Pharmacology,
SRMC and RI,
Porur,
Chennai |
| Type of Sponsor |
Other [Individual PI] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Deepan K |
Sri Ramachandra Medical Collge Hospital |
Medical ward, 1st Floor,
G Block,
SRMC & RI,
Porur,
Chennai
Chennai
TAMIL NADU |
9566499286
m0523005@sriher.edu.in |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Research Ethics Committee (For PG Students of Medical College) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B348||Other viral infections of unspecified site, (2) ICD-10 Condition: B348||Other viral infections of unspecified site, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
IV Fuids with Astymin SN |
Standard therapy with IV fluids along with Mix of AminoAcids |
| Comparator Agent |
Standard Care of therapy |
IV Fluids with Symptomatic treatment |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1) Patients above 18 years of age diagnosed with dengue.
2) Adults confirmed dengue infection by positive NS1 antigen or IgM positive (ELISA Method).
3) All patients recommended for hospitalization and intravenous (IV) fluid therapy.
4) Diagnosed with Dengue fever without warning signs according to 2009 guidelines in In-Patient ward. |
|
| ExclusionCriteria |
| Details |
1) Children below 18 years of age.
2) Adults and children with comorbid conditions associated with cardiovascular, kidney, liver, respiratory, tumour.
3) Critical dengue cases DHF with warning signs according to 2009 guidelines.
4) Pregnant women, Lactating women.
5) Patients with history of dengue vaccine in the recent past.
6) Hypersensitivity to previous amino acid infusion. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 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. |
Comparison of change in reduction in duration of fever compared to standard therapy |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To evaluate the duration of hospital stay
2. Subjective self-assessment by the patient
3. Physician assessment of improvement
4. Safety assessment. |
• Length of hospitalisation,
• Analgesic intake, and
• Other parameters like Rash, myalgia, arthralgia, headache, nausea, and conjunctivitis. Fevers, chills, and malaise amongst to be evaluated. |
|
|
Target Sample Size
|
Total Sample Size="96"
Sample Size from India="96"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
23/12/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
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:
1. 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. 2. 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. 3. Endpoints: • Primary: Reduction in fever duration. • Secondary: Improvements in hospital stay duration, symptom relief, and platelet count changes. 4. Significance: • Dengue has no specific antiviral treatment, and supportive care is critical. • Amino acids could enhance protein balance, boost immunity, and aid recovery. 5. 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. |