Platenza Tablets for Dengue fever
- Conditions
- Health Condition 1: null- Dengue Fever
- Registration Number
- CTRI/2018/03/012738
- Lead Sponsor
- The Himalaya Drug Company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 60
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.
Subject diagnosed with DHF Grade 3 or 4.
Subjects with hypotension / hypovolemia.
Subjects platelet count <30000/µL.
Subject presenting with hemorrhagic phenomena at screening evidenced with positive Torniquette test, petechiae, ecchymoses, or purpura, bleeding from the mucosa, gastrointestinal tract, injection sites or other locations and haemetemesis or melaena are excluded from the study.
•Bleeding disorders or those taking blood thinning medications such as aspirin or warfarin.
•Subjects with the history of diabetes mellitus treated with any Oral Hypoglycaemic Agents.
•Subjects with the history of clinically significant cardiovascular condition treated with the medication Amiodarone
•Subjects with infectious condition treated with antibiotics like penicillin G , ampicillin, amoxyclav, cephalothin,polymyxin B, rifampicin, amikacin, nalidixic acid, gentamycin, cholarmphenicol, oflxacin.
•Subjects with established hematological disorders including idiopathic thrombocytopenia purpura, leukemia, hemophilia.
•Has received blood products or blood transfusion during the current hospital stay Or during last one month
•Hypersensitive to any of the ingredients.
•Use of prescription medication to treat gastric problems
•Pregnant & lactating women.
•Not willing to sign informed consent form
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Increase in the platelet counts in dengue fever with low platelet counts. <br/ ><br>Clinically significant Improvement in the signs and symptoms of dengue fever with thrombocytopeniaTimepoint: Clinical Parameters: Screening, end of Day 3, end of Day 6 and at the end of Day 10(End of the study) <br/ ><br>Lab parameters: Screening and at the end of Day 10 (End of the study) <br/ ><br>Study Specific Efficacy Parameters: Screening, end of Day 3, Day 6 and end of Day 10 (End of the study)
- Secondary Outcome Measures
Name Time Method Significant improvement in clinical signs and symptoms <br/ ><br>Significant improvement in the quality of lifeTimepoint: Screening and End of the study