Health Condition 1: null- Dengue patients
Conditions
Interventions
Intervention1: CARIMAX (Papaya leaf extract 1100mg): three times daily (TID)
Total duration : 5 days
Route: by orally
Control Intervention1: Placebo: Three times daily (TID)
Sponsors
Katra Phytochem Pvt ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients who were confirmed to have DF or DHF grade I and II, 2. Subjects must sign with date an Informed Consent (ICF) prior to any evaluation and participation in the trial, 3. Male and female patients above 18 years and below 60 years old, 4. Patients with a baseline alanine transaminase (ALT) level of not more than 3 times of the upper limit of the normal range (not more than 165â??U/L),
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating women, 2. Patients with Dengue hemorrhagic fever grade III and IV, 3. Patients with platelet count less than 20000/microlitre 4. Patients with thrombocytopenia presenting with active bleeding 5. Patients who have received blood or blood products transfusion during the current illness or during past one week, 6. Patients with thrombocytopenia Purpura (ITP), Leukemia, Hemophilia or bleeding diathesis 7. Patients who developed Hepatitis with a serum ALT level 3 times higher than the upper limit of the normal range ( >165â??U/L). 8. Impaired renal function with serum creatinine >1.5 mg/dl(males) and >1.4 mg/dl(females) 9. Participation in another trial with another investigational drug within 1 month prior to informed consent. 10. The presence of any other condition that leads the investigator to conclude that the patient is inappropriate for inclusion in the clinical study 11. Hypersensitivity to any of the components of the investigational formulation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Increase in the platelet counts from the baseline levels to the end of therapyTimepoint: Day 1, Day 2,Day 3,,Day 4 and Day 5 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in the RBC levels from the baseline levels till the end of therapy Change in WBC levels from the baseline levels till the end of therapy Change in the Haematocrit levels from the baseline levels to the end of therapy Comparison of incidence and rate of adverse events occurred between the two arms to evaluate the safety and tolerability Timepoint: Day 1, Day 2,Day 3,,Day 4 and Day 5 | — |
Countries
India
Contacts
Public ContactDrNagabhushan KH
Katra Phytochem Pvt ltd
Outcome results
None listed