Ignite Creation Date:
2025-12-25 @ 2:39 AM
Ignite Modification Date:
2025-12-30 @ 8:18 PM
Study NCT ID:
NCT05360134
Status:
UNKNOWN
Last Update Posted:
2022-05-04
First Post:
2022-04-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Platelet Augmentation Using C. Papaya Leaf Extract in Live Donor Liver Transplantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013921', 'term': 'Thrombocytopenia'}], 'ancestors': [{'id': 'D001791', 'term': 'Blood Platelet Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D000095542', 'term': 'Cytopenia'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-04-30', 'studyFirstSubmitDate': '2022-04-25', 'studyFirstSubmitQcDate': '2022-04-30', 'lastUpdatePostDateStruct': {'date': '2022-05-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'POD 7 Platelet Counts', 'timeFrame': '7th post-operative day'}], 'secondaryOutcomes': [{'measure': 'Pre-operative platelet counts', 'timeFrame': '1 day prior to surgery'}, {'measure': 'Intra-operative blood loss and transfusion requirements', 'timeFrame': 'Day 0'}, {'measure': 'Incidence of Early allograft dysfunction', 'timeFrame': 'First 7 days following live donor liver transplant'}, {'measure': 'Incidence of prolonged post-operative drainage', 'timeFrame': 'First 14 days following live donor liver transplant'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Thrombocytopenia']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All consenting adults who are planned to undergo live donor liver transplant with platelet counts less than or equal to 75000/μL preoperatively.\n\nExclusion Criteria:\n\n* Patients who do not consent\n* ALF \\& ACLF\n* Pediatric transplant recipients\n* Allergic to papaya\n* Preoperative platelet counts \\>75,000/ μL\n* Recent history of DVT'}, 'identificationModule': {'nctId': 'NCT05360134', 'briefTitle': 'Platelet Augmentation Using C. Papaya Leaf Extract in Live Donor Liver Transplantation', 'organization': {'class': 'OTHER', 'fullName': 'Institute of Liver and Biliary Sciences, India'}, 'officialTitle': 'Efficacy and Safety of Platelet Augmentation Using Carica Papaya Leaf Extract in Live Donor Liver Transplantation Recipients - a Pilot Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'ILBS-LDLT-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Carica Papaya Arm', 'description': '1100mg of Carica Papaya Leaf extract administered three times daily for upto one week preoperatively and from post-operative day 3 to day 7.', 'interventionNames': ['Drug: Carica Papaya Leaf Extract']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Arm', 'description': 'Placebo administered 3 time daily for upto one week preoperatively and from post-operative day 3 to day 7.', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Carica Papaya Leaf Extract', 'type': 'DRUG', 'description': 'Carica Papaya Leaf Extract 1100 mg X TDS started at least 3 days preoperatively and continued on post operative day 3 to day 7', 'armGroupLabels': ['Carica Papaya Arm']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Placebo will be given in a similar manner', 'armGroupLabels': ['Placebo Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '110070', 'city': 'New Delhi', 'state': 'National Capital Territory of Delhi', 'status': 'RECRUITING', 'country': 'India', 'contacts': [{'name': 'Dr Anubhav, MS', 'role': 'CONTACT', 'email': 'anubhav.pawar@gmail.com', 'phone': '01146300000'}], 'facility': 'Institute of Liver & Biliary Sciences', 'geoPoint': {'lat': 28.62137, 'lon': 77.2148}}], 'centralContacts': [{'name': 'Anubhav Harshit Kumar, MCh', 'role': 'CONTACT', 'email': 'anubhav.pawar@gmail.com', 'phone': '8860188337'}], 'overallOfficials': [{'name': 'Viniyendra Pamecha, FEBS', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Institute of Liver & Biliary Sciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institute of Liver and Biliary Sciences, India', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}