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

Not Applicable

Completed

• Conditions: Dengue patients

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

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

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01-06
• Last Update Posted: 2017-05-18

Recruitment & Eligibility

• Status: Completed
• Sex: All
• 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 (>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.

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.	Increase in the platelet counts from the baseline levels to the end of therapy.

Secondary Outcome Measures

Name	Time	Method
•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

Trial Locations

Locations (5)

Dr.B.R Ambedkar Medical college; 🇮🇳 Bangalore, KARNATAKA, India

King George Hospital; 🇮🇳 Visakhapatnam, ANDHRA PRADESH, India

Prashanth Hospital; 🇮🇳 Bangalore, KARNATAKA, India

Rajiv Gandhi Institute of Medical Sciences; 🇮🇳 Srikakulam, ANDHRA PRADESH, India

Sri Venkateshwara Hospital; 🇮🇳 Bangalore, KARNATAKA, India

Dr.B.R Ambedkar Medical college

🇮🇳Bangalore, KARNATAKA, India

DrAmbanna Gowda

Principal investigator

09845270377

dr.ambanagowda@gmail.com