Skip to main content
MedPathMedPath Home
Clinical Trials/CTRI/2018/07/014988
CTRI/2018/07/014988
Completed
Phase 4

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

Mi Lab LifeSciencesP Limited0 sites0 target enrollmentTBD
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Not specified
Sponsor
Mi Lab LifeSciencesP Limited
Status
Completed
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
4 years ago
Study Type
Interventional

Investigators

Sponsor
Mi Lab LifeSciencesP Limited

Eligibility 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

  • •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.

Outcomes

Primary Outcomes

Not specified

Similar Trials

Recruiting
Phase 4
Benefit of carica papaya leaf extract in cancer patientsHealth Condition 1: null- Cancer
CTRI/2017/07/008954Katra Phytochem Pvt ltd
Completed
Phase 4
A life saving measure for Dengue patients :Carica Papaya Leaf ExtractHealth Condition 1: null- Dengue patients
CTRI/2015/05/005806Micro Labs Ltd300
Recruiting
Phase 3
Evaluation of Clinical Endpoints of Two Sucralfate suspension, 1g/10m
CTRI/2013/04/003538HiTech Pharmacal Co Inc575
Recruiting
Phase 2
To Compare the Effect of a Subcutaneous Canakinumab Administration to Placebo in Patients With Impaired Glucose Tolerance or Patients With Type 2 Diabetes With Differing Baseline Diabetes TherapiesHealth Condition 1: null- Diabetes Mellitus Type 2Impaired Glucose Tolerance
CTRI/2010/091/000151ovartis Healthcare Private Limited244
Active, not recruiting
Not Applicable
A Multi-Center, Double-Blind, Placebo-Controlled, Parallel Group Safety Study ofPulmonary Function in Patients with Reduced Lung Function Treated with BOTOX®(Botulinum Toxin Type A) Purified Neurotoxin Complex for Focal Upper LimbSpasticity Due to Upper Motor Neuron Syndrome
EUCTR2005-004834-42-HUAllergan150