Health Condition 1: null- Thrombocytopenia associated with Dengue fever in Paediatric Patients
Conditions
Interventions
Intervention1: Carica Papaya leaf extract (Caripill) syrup: Participants aged above 1 year and below 5 years were administered with 275 mg / 5 ml of Carica Papaya leaf extract (Caripill) syrup three
Sponsors
Micro Labs Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1.Subjects who are confirmed to have DF or DHF grade I and II by NS1 antigen test 2.Subjects having thrombocytopenia with platelet count 30,000-1,00,000 /micro litre 3.Subjects with a baseline alanine transaminase (ALT) level of not more than 3 times of the upper limit of the normal range (not more than 165 U/L) 4.Subjects parent/ guardian who is willing to give informed consent to participate in study.
Exclusion criteria
Exclusion criteria: 1. Subjects with Dengue hemorrhagic fever grade III and IV 2. Subjects with platelet count less than 30,000/micro litre 3. Subjects who have received blood or blood products transfusion during the current illness 4. Subjects with thrombocytopenia Purpura (ITP), Leukaemia, Haemophilia 5. Subjects who have a serum ALT level 3 times higher than the upper limit of the normal range ( >165 U/L) 6. Impaired renal function with serum creatinine >1.5 mg/dl(males) and >1.4 mg/dl(females) 7. Participation in another trial with an investigational drug within 1 month prior to this trial. 8. Hypersensitivity to any of the components of the formulation 9. The presence of any other condition that leads the investigator to conclude that the patient is inappropriate for inclusion in this clinical study.
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 therapyTimepoint: Baseline (Day 1 )Day 2, Day 3 Day 4 and Day 5 (End of Study);Change in WBC levels from the baseline levels till the end of therapyTimepoint: Baseline (Day 1 )Day 2, Day 3 Day 4 and Day 5 (End of Study);Tolerability and safety assessment based on adverse effects as mentioned by the parents and evaluated by the investigatorTimepoint: Baseline to end of the Study | — |
Countries
India
Contacts
Public ContactDr Manjula
Micro Labs Limited, Bangalore
Outcome results
None listed