Clinical trial for A life saving measure for Dengue patients :Carica Papaya Leaf Extract

Phase 4

Completed

Registration Number: CTRI/2018/07/014988

Lead Sponsor: Mi Lab LifeSciencesP Limited

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1.Male and female patients above 18 years and below 60 years old,

2.Patients who are confirmed to have DF or DHF grade I and II by NS1 antigen test,

3.Patients having thrombocytopenia with at platelet count between 30,000 /micro litre to 150,000/micro litre,

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),

5.Patient who is willing to give informed consent to participate in study

Exclusion Criteria

1.Patients with Dengue hemorrhagic fever grade III and IV,

2.Patients with platelet count less than 30,000/micro litre,

3.Pregnant or lactating women,

4.Patients who have received blood or blood products transfusion during the current illness,

5.Patients with thrombocytopenia Purpura (ITP), Leukemia, Hemophilia,

6.Patients who have a serum ALT level 3 times higher than the upper limit of the normal range ( >165â??U/L),

7.Impaired renal function with serum creatinine >1.5 mg/dl(males) and >1.4 mg/dl(females)

8.Participation in another trial with an investigational drug within 1 month prior to this trial.

9. Hypersensitivity to any of the components of the formulation,

10.The presence of any other condition that leads the investigator to conclude that the patient is inappropriate for inclusion in this clinical study.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Increase in the platelet counts from the baseline <br/ ><br>levels to the end of therapyTimepoint: Day 1,Day 2,Day 3,Day 4 and Day 5

Secondary Outcome Measures

Name	Time	Method
Change in the RBC levels from the baseline <br/ ><br>levels till the end of therapy <br/ ><br>Change in WBC levels from the baseline levels <br/ ><br>till the end of therapy <br/ ><br>Change in the Haematocrit levels from the <br/ ><br>baseline levels to the end of therapy <br/ ><br>Comparison of incidence and rate of adverse <br/ ><br>events occurred between the two arms to <br/ ><br>evaluate the safety and tolerability. <br/ ><br>Timepoint: Day 1,Day 2,Day 3,Day 4 and Day 5