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

A Multi-centric, Double blind, Placebo controlled, Randomized, observational study to evaluate the Efficacy and Safety of Carica Papaya Leaf Extract, as empirical therapy for thrombocytopenia associated with dengue feverSafety of Carica Papaya Leaf Extract, as empirical therapy for thrombocytopenia associated with dengue fever

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2015/05/005806

Enrollment

300

Registered

2015-05-25

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Dengue patients

Interventions

Intervention1: Carica Papaya leaf extract: Carica Papaya leaf extract (Caripill) per orally with a strength of 1100 mg tablet, three times a day for a period of 5 days as an adjuvant and the control g

Eligibility

Inclusion criteria

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/Î¼L, 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

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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
â?¢Change in the RBC levels from the baseline levels till the end of therapy â?¢Change in WBC levels from the baseline levels till the end of therapy â?¢Change in the Haematocrit levels from the baseline levels to the end of therapy â?¢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	—

Measure

Time frame

â?¢Change in the RBC levels from the baseline levels till the end of therapy â?¢Change in WBC levels from the baseline levels till the end of therapy â?¢Change in the Haematocrit levels from the baseline levels to the end of therapy â?¢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 ContactDrKasture Prabhu

Mcro Labs Ltd

khnagabhushan@microlabs.in

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026