Clinical trial for 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, (ZYBORICA TABLET ) as empirical therapy for thrombocytopenia associated with dengue fever

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2018/07/014988

Enrollment

Registered

2018-07-20

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

None listed

Interventions

Intervention1: Carica Papaya Leaf Extract, (ZYBORICA TABLET) 1100mg: dose :1100mg frequency: 3 times per day after food route of administration : Oral Control Intervention1: Placebo containing starc

Eligibility

Inclusion criteria

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

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.

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 ContactMr LAKSHMANA PERUMAL SPT

Mi Lab LifeSciences(P) Limited

lakshman@milablifesciences.com8050717400

Outcome results