se of HYDRODENG SACHET in Dengue fever patients

Phase 3

• Conditions: Health Condition 1: A90- Dengue fever [classical dengue]

• Registration Number: CTRI/2024/04/065599
• Lead Sponsor: Tirupati Medicare Limited, India.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Proper written informed consent obtained from the patient before any

procedure performed.

2. Males and females between the age of 18-75 years with an oral temperature of

more than 38.0°C (100.4°F). with or without associated rash, body pain and joint

pain, severe headache especially behind the eyes, nausea and vomiting.

3. Patients having confirmed Dengue Viral fever (Positive NS1 antigen card

test) with thrombocytopenia, with a platelet count between 50,000 /micro

litre to150,000/micro litre.

4. Subjects with stable vitals like pulse and blood pressure

5. Patient should have not participated in any other clinical trial during the past 3

months.

Exclusion Criteria

1. Patients with Dengue hemorrhagic fever grade III and IV

2. Patients with platelet count less than 50,000/micro litre.

3. Pregnant or lactating women

4. Patients who have received blood or blood products transfusion during the

current illness

5. Patients with thrombocytopenia Purpura (ITP), Leukemia, Hemophilia

6. Patients who have a serum ALT level 3 times higher than the upper limit

of the normal range(greater than 165 U/L),

7. Impaired renal function with serum creatinine greater than 1.5 mg/dl ( males) and greater than 1.4 mg/dl(females),

8. Hypersensitivity to any of the components of the formulation,

9. The presence of any other condition that leads the investigator to conclude that the patient is inappropriate for inclusion in this clinical study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
a)Assessment of efficacy parameters, namely platelet count, bleeding time, clotting <br/ ><br>time, hematocrit– baseline & on each day, from day 1 to day 3 and on days 5, 7 and <br/ ><br>10. Electrolytes and hydration status will be assessed on baseline and post study. <br/ ><br>b)Assessment of clinical parameters namely temperature, fever score, arthralgia, <br/ ><br>myalgia, headache and loss of appetite - baseline and on day 1 to day 3 and on days <br/ ><br>5, 7 and 10.Timepoint: baseline, day 1 to day 3, days <br/ ><br>5, 7 and 10.

Secondary Outcome Measures

Name	Time	Method
To monitor for any adverse events during the study period and assess the quality <br/ ><br>of life using a pre-and post-feedback questionnaire. <br/ ><br>All the outcome parameter will be compared between the test and comparator.Timepoint: Day 0 and day 10