CTRI/2015/05/005806
Completed
Post Marketing Surveillance
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
Overview
- Phase
- Post Marketing Surveillance
- Status
- Completed
- Sponsor
- Micro Labs Ltd
- Enrollment
- 300
- Locations
- 5
- Primary Endpoint
- Increase in the platelet counts from the baseline levels to the end of therapy.
Overview
Brief Summary
Carica papayaleaf extract has attracted attentions because of the promising results shown from the various studies conducted in South East Asian countries on the effectiveness of carica papayaleaf extract on increasing the platelet counts in patients with thrombocytopenia associated with Dengue.
This trial is designed as Multi-centric, double blind, placebo controlled, Randomized, Prospective study in patients aged 18 years and above and having thrombocytopenia associated with dengue fever
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Participant and Investigator Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
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 (>165 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.
Outcomes
Primary Outcomes
Increase in the platelet counts from the baseline levels to the end of therapy.
Time Frame: Increase in the platelet counts from the baseline levels to the end of therapy.
Secondary Outcomes
- •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)
Investigators
Study Sites (5)
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