Platelet Augmentation Using C. Papaya Leaf Extract in Liv... | NCT05360134

Studies
Platelet Augmentation Using C. Papaya Leaf Extract in Live Donor Liver Transplantation

NCT05360134

Sponsor

Institute of Liver and Biliary Sciences, India

Status

Unknown status

Last Update Posted

May 4, 2022Actual

Enrollment

30Estimated

Phase

Not Applicable

Conditions

Thrombocytopenia

Interventions

Carica Papaya Leaf Extract
Placebo

Countries

India

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2021Actual

Primary Completion Date

Oct 1, 2022Estimated

Completion Date

Dec 31, 2022Estimated

First Submitted Date

Apr 25, 2022

First Submission Date that Met QC Criteria

Apr 30, 2022

First Posted Date

May 4, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 30, 2022

Last Update Posted Date

May 4, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This project is a pilot randomized controlled trial aimed at investigating the potential of Carica Papaya Leaf Extract, available in a marketed pill formulation, in increasing platelet counts in live donor liver transplant recipients. Carica Papaya leaf extract has shown positive results in increasing platelet counts in various medical conditions such as Dengue, Immune thrombocytopenic purpura and chemotherapy induced thrombocytopenia. Thrombocytopenia i.e. low platelet counts are a common occurrence in patients with chronic liver disease undergoing live donor liver transplant. It has been observed in previous studies that live donor liver transplant recipients who have persistent thrombocytopenia have significantly worse outcomes as compared to patients who have higher platelet counts. Positive results in this study lead to further studies in assessing the impact of platelet augmentation in live donor liver transplant recipients.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Carica Papaya Arm	Experimental	1100mg of Carica Papaya Leaf extract administered three times daily for upto one week preoperatively and from post-operative day 3 to day 7.	Drug: Carica Papaya Leaf Extract
Placebo Arm	Placebo Comparator	Placebo administered 3 time daily for upto one week preoperatively and from post-operative day 3 to day 7.	Other: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Carica Papaya Leaf Extract	Drug	Carica Papaya Leaf Extract 1100 mg X TDS started at least 3 days preoperatively and continued on post operative day 3 to day 7	Carica Papaya Arm

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
POD 7 Platelet Counts		7th post-operative day

Secondary Outcomes

Measure	Description	Time Frame
Pre-operative platelet counts		1 day prior to surgery
Intra-operative blood loss and transfusion requirements		Day 0
Incidence of Early allograft dysfunction

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All consenting adults who are planned to undergo live donor liver transplant with platelet counts less than or equal to 75000/μL preoperatively.

Exclusion Criteria:

Patients who do not consent
ALF & ACLF
Pediatric transplant recipients
Allergic to papaya
Preoperative platelet counts >75,000/ μL
Recent history of DVT

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Anubhav Harshit Kumar, MCh	Contact	8860188337		anubhav.pawar@gmail.com

Overall Officials

Name	Affiliation	Role
Viniyendra Pamecha, FEBS	Institute of Liver & Biliary Sciences	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Institute of Liver & Biliary Sciences	Recruiting	New Delhi	National Capital Territory of Delhi	110070	India

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D013921	Thrombocytopenia

Ancestor Terms

ID	Term
D001791	Blood Platelet Disorders
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases
D000095542	Cytopenia

Browse Leaves

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Browse Branches

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