A Randomized, Open label, parallel group, Comparative clinical study to evaluate the efficacy and safety of HYDRODENG SACHET with Cariprill in Dengue fever.
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- a)Assessment of efficacy parameters, namely platelet count, bleeding time, clotting
Study Overview
Brief Summary
The subjects who fulfilled the inclusion and exclusion criteria will be enrolled in the study. 50 participants diagnosed with Dengue viral fever with or without
thrombocytopenia will be enrolled in this study in two separate arms.
The IP will be administered orally thrice daily for 7- 10 days.
The following parameters will be monitored.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 75.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Proper written informed consent obtained from the patient before any procedure performed.
- •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.
- •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.
- •Subjects with stable vitals like pulse and blood pressure
- •Patient should have not participated in any other clinical trial during the past 3 months.
Exclusion Criteria
- •Patients with Dengue hemorrhagic fever grade III and IV
- •Patients with platelet count less than 50,000/micro litre.
- •Pregnant or lactating women
- •Patients who have received blood or blood products transfusion during the current illness
- •Patients with thrombocytopenia Purpura (ITP), Leukemia, Hemophilia
- •Patients who have a serum ALT level 3 times higher than the upper limit of the normal range(greater than 165 U/L),
- •Impaired renal function with serum creatinine greater than 1.5 mg/dl ( males) and greater than 1.4 mg/dl(females),
- •Hypersensitivity to any of the components of the formulation,
- •The presence of any other condition that leads the investigator to conclude that the patient is inappropriate for inclusion in this clinical study.
Outcomes
Primary Outcomes
a)Assessment of efficacy parameters, namely platelet count, bleeding time, clotting
Time Frame: baseline, day 1 to day 3, days | 5, 7 and 10.
time, hematocrit– baseline & on each day, from day 1 to day 3 and on days 5, 7 and
Time Frame: baseline, day 1 to day 3, days | 5, 7 and 10.
10. Electrolytes and hydration status will be assessed on baseline and post study.
Time Frame: baseline, day 1 to day 3, days | 5, 7 and 10.
b)Assessment of clinical parameters namely temperature, fever score, arthralgia,
Time Frame: baseline, day 1 to day 3, days | 5, 7 and 10.
myalgia, headache and loss of appetite - baseline and on day 1 to day 3 and on days
Time Frame: baseline, day 1 to day 3, days | 5, 7 and 10.
5, 7 and 10.
Time Frame: baseline, day 1 to day 3, days | 5, 7 and 10.
Secondary Outcomes
- To monitor for any adverse events during the study period and assess the quality(of life using a pre-and post-feedback questionnaire.)
Investigators
Dr M Sakthi Balan MD
Ki3 Private Limited