Health Condition 1: null- Dengue fever associated with low platelet counts
Conditions
Interventions
Intervention1: Platenza Tablets: Two Tablets twice daily oral for a period of 10 days
Control Intervention1: Carica Papaya leaf extract Tablets: One Tablet three times daily oral for a period of 10 da
Sponsors
The Himalaya Drug Company
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: Subject diagnosed with DHF Grade 3 or 4. Subjects with hypotension / hypovolemia. Subjects platelet count 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
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 thrompocytopeniaTimepoint: Efficacy parameters will be assessed at Screening/ Baseline, Day 3, Day 5, Day 7 and Day 10 (End of the study) Clinical Parameters - Screening/Baseline, Day 3, Day 5, Day 7 and Day 10 (End of the Study) Hematological and Biochemical Parameters - At entry and at the end of Day 10 (end of the study) Qol will be assessed before and after the study | — |
Secondary
| Measure | Time frame |
|---|---|
| No adverse events reported or observed during the study period Imporoved quality of lifeTimepoint: Screening and end of the study(end of Day 10) | — |
Countries
India
Contacts
Public ContactDr Srikrishna H A
The Himalaya Drug Company
Outcome results
None listed