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

NCT ID: NCT05360134

Last Updated: 2022-05-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-01

Study Completion Date

2022-12-31

Brief Summary

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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

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Conditions

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Thrombocytopenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Carica Papaya Arm

1100mg of Carica Papaya Leaf extract administered three times daily for upto one week preoperatively and from post-operative day 3 to day 7.

Group Type EXPERIMENTAL

Carica Papaya Leaf Extract

Intervention Type 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

Placebo Arm

Placebo administered 3 time daily for upto one week preoperatively and from post-operative day 3 to day 7.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo will be given in a similar manner

Interventions

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Carica Papaya Leaf Extract

Carica Papaya Leaf Extract 1100 mg X TDS started at least 3 days preoperatively and continued on post operative day 3 to day 7

Intervention Type DRUG

Placebo

Placebo will be given in a similar manner

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institute of Liver and Biliary Sciences, India

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Viniyendra Pamecha, FEBS

Role: STUDY_DIRECTOR

Institute of Liver & Biliary Sciences

Locations

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Institute of Liver & Biliary Sciences

New Delhi, National Capital Territory of Delhi, India

Site Status RECRUITING

Countries

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India

Central Contacts

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Anubhav Harshit Kumar, MCh

Role: CONTACT

8860188337

Facility Contacts

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Dr Anubhav, MS

Role: primary

01146300000

Other Identifiers

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ILBS-LDLT-01

Identifier Type: -

Identifier Source: org_study_id

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