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

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2015/05/005806
• Date of registration: 25-05-2015
• Prospective Registration: Yes
• Primary sponsor: Micro Labs Ltd
• Public title: A life saving measure for Dengue patients :Carica Papaya Leaf Extract
• Scientific title: 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
• Date of first enrolment: 01-06-2015
• Target sample size: 300
• Recruitment status: Completed
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=11775
• Study type: Interventional
• Study design: Randomized, Parallel Group, Placebo Controlled Trial; Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:An Open list of random numbers Blinding and masking:Participant and Investigator Blinded
• Phase: Post Marketing Surveillance

Countries of recruitment

India

Contacts

• Name: DrK H Nagabhushan
• Affiliation: Mcro Labs Ltd

• Name: DrKasture Prabhu
• Affiliation: Mcro Labs Ltd

Key inclusion & exclusion 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/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.



Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Health Condition 1: null- Dengue patients

Intervention(s)

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 group shall receive Placebo for the same frequency and duration as the intervention group. All the subjects shall be followed up daily for 5 days
Control Intervention1: Placebo: 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 group shall receive Placebo for the same frequency and duration as the intervention group. All the subjects shall be followed up daily for 5 days

Primary Outcome(s)

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(s)

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

Secondary ID(s)

NIL

Source(s) of Monetary Support

Micro Labs Ltd No 27 Race course road Bangalore 560001

Ethics review

Status: Approved
Approval date: 07/02/2015
Contact:

Institutional ethics committee Dr.B.R Ambedkar Medical college and Hospital

Status: Approved
Approval date: 10/04/2015
Contact:

sri venkateswara hospital ethics committee

Status: Approved
Approval date: 20/04/2015
Contact:

institutional ethics committee king george hospital

Status: Approved
Approval date: 19/05/2015
Contact:

Prashanth Hospital Ethics Committee

Status: Approved
Approval date: 20/05/2015
Contact:

institutional ethics committeeRajiv Gandhi Institute of Medical Sciences