Platenza Tablets for Dengue fever

Phase 2

Completed

• Registration Number: CTRI/2018/02/011789
• Lead Sponsor: The Himalaya Drug Company

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2017-08-27
• Last Update Posted: 25 July 2023

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 40

Inclusion Criteria

1. Both male and female subjects between the age group of >=18 years to <= 60years who are confirmed to have DF (Dengue Fever) grade 1 and grade 2 by IgG, IgM and NS1 Antigen.

2.Subjects who have been diagnosed with clinically significant dengue fever associated with thrombocytopenia with platelet count between 30000/µL to 1,00,000/µL.

3., subjects with the SGPT level not more than 2 times the upper limit of normal.

4.subjects with stable vitals like pulse and blood pressure

5.subjects willing to give written informed consent

6.subjects who had not participated in similar kind of study in last 3 months were included into the study.

Exclusion Criteria

1. Subject diagnosed with DHF Grade 3 or 4, with hypotension / hypovolemia, subjects with platelet count <30000/µL.

2.subjects presenting with hemorrhagic phenomena at screening evidenced with positive torniquette test, petechiae, ecchymoses, or purpura, bleeding from the oral mucosa, gastrointestinal tract, injection sites or other locations and haemetemesis or melaena.

3.subjects with dengue fever associated with any bleeding disorders or those taking blood thinning medications such as aspirin or warfarin.

4.subjects with the history of any severe metabolic disorders.

5.pregnant & lactating women

6.subjects not willing to sign informed consent form are excluded from the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Complete releif from clinical signs and symptoms of Dengue fever with normalization of platelet countsTimepoint: Study Specific Efficacy parameters - Platelet Counts - screening, Day 1, Day 2, Day 3, Day 4,Day 6, Day 8 and Day 10. <br/ ><br>Clinical Signs and Symptoms - Screening, Day 3, Day 6 and Day 10

Secondary Outcome Measures

Name	Time	Method
o reported or observed adverse events with improved Quality of Life <br/ ><br>Good overall compliance to the study intervention.Timepoint: AE/SAE - Screening, Day3, Day 6, and Day 10 <br/ ><br>QOL - Screening and at the end of Day 10 (End of the Study)