Health Condition 1: null- Dengue Fever with thrombocytopenia
Conditions
Interventions
Intervention1: Platenza Tablets: 2 tablets twice daily for a period of 10 days
Control Intervention1: Leaf extract tablets of Carica Papaya: 1 tablet thrice daily for a period of 10 days
Control Inter
Sponsors
The Himalaya Drug Company Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Both male and female subjects between the age group of >=18 years to 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
Exclusion criteria: 1 Subject diagnosed with DHF Grade 3 or 4. 2 Subjects platelet count 3 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. 4 Bleeding disorders or those taking blood thinning medications such as aspirin or warfarin. 5 Subjects with the history of diabetes mellitus treated with any Oral Hypoglycaemic Agents. 6 Subjects with the history of clinically significant cardiovascular condition treated with the medication Amiodarone 7 Subjects with infectious condition treated with antibiotics like penicillin G , ampicillin, amoxyclav, cephalothin,polymyxin B, rifampicin, amikacin, nalidixic acid, gentamycin, cholarmphenicol, oflxacin. 8 Subjects with established hematological disorders including idiopathic thrombocytopenia purpura, leukemia, hemophilia. 9 Has received blood products or blood transfusion during the current hospital stay Or during last one month 10 Hypersensitive to any of the ingredients. 11 Use of prescription medication to treat gastric problems 12 Pregnant & lactating women. 13 Subjects not willing to sign informed consent form.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Increase in the platelet counts in dengue fever with low platelet counts. Clinically significant improvement in the signs and symptoms of dengue fever with thrombocytopenia compared to that of the comparator agent and the standard line of treatmentTimepoint: Clinical Parameters -Screening/ Baseline, Day 3, Day 6, and Day 10 (End of the study) Haematological and Laboratory Parameters - At entry and at the end of the study QOL - At entry and at the end of the study | — |
Secondary
| Measure | Time frame |
|---|---|
| No adverse events reported or observed during the study period Improved quality of life and overall compliance to the study interventionTimepoint: Screening and end of the study(end of Day 10) | — |
Countries
India
Contacts
Public ContactDr Srikrishna H A
The Himalaya Drug Company Ltd
Outcome results
None listed