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

Phase 4

Completed

• Conditions: Health Condition 1: null- Dengue patients

• Registration Number: CTRI/2015/05/005806
• Lead Sponsor: Micro Labs Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 300

Inclusion Criteria

1.Subjects must sign with date an Informed Consent (ICF) prior to any evaluation and participation in the trial,

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

3.Patients who were confirmed to have DF or DHF grade I and II,

4.Patients with a platelet count of less than 100,000/μL,

5.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 165U/L),

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Increase in the platelet counts from the baseline levels to the end of therapy.Timepoint: Increase in the platelet counts from the baseline levels to the end of therapy.

Secondary Outcome Measures

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