Health Condition 1: A90- Dengue fever [classical dengue]
Conditions
Interventions
Intervention1: HYDRODENG SACHET 100 mg: Orally.
One sachet thrice daily – For 7 - 10 days
Control Intervention1: Tab. Cariprill 1100 mg: Thrice daily orally for 7-10 days
Sponsors
Tirupati Medicare Limited, India.
Eligibility
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| a)Assessment of efficacy parameters, namely platelet count, bleeding time, clotting time, hematocrit– baseline & on each day, from day 1 to day 3 and on days 5, 7 and 10. Electrolytes and hydration status will be assessed on baseline and post study. b)Assessment of clinical parameters namely temperature, fever score, arthralgia, myalgia, headache and loss of appetite - baseline and on day 1 to day 3 and on days 5, 7 and 10.Timepoint: baseline, day 1 to day 3, days 5, 7 and 10. | — |
Secondary
| Measure | Time frame |
|---|---|
| To monitor for any adverse events during the study period and assess the quality of life using a pre-and post-feedback questionnaire. All the outcome parameter will be compared between the test and comparator.Timepoint: Day 0 and day 10 | — |
Countries
India
Contacts
Public ContactDr Gayathri Sivakumar
Ki3 Private Limited
Outcome results
None listed