ThrombocytopeniaNCT05360134
Platelet Augmentation Using C. Papaya Leaf Extract in Live Donor Liver Transplantation
A study testing Carica Papaya Leaf Extract in people with Thrombocytopenia, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Thrombocytopenia
- What is being tested?
- Carica Papaya Leaf Extract
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteIndia
- Study dates
- 1 Jan 2021to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All consenting adults who are planned to undergo live donor liver transplant with platelet counts less than or equal to 75000/μL preoperatively.
Who cannot join
- Patients who do not consent
- ALF \& ACLF
- Pediatric transplant recipients
- Allergic to papaya
- Preoperative platelet counts >75,000/ μL
- Recent history of DVT
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Institute of Liver & Biliary Sciences
New Delhi, National Capital Territory of Delhi, 110070
Dr Anubhav, MS, 01146300000, anubhav.pawar@gmail.com
About this study
Official title: Efficacy and Safety of Platelet Augmentation Using Carica Papaya Leaf Extract in Live Donor Liver Transplantation Recipients - a Pilot Randomized Controlled Trial
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.
- Conditions
- Thrombocytopenia
- Being tested
- Carica Papaya Leaf Extract, Placebo
- Medical subject headings
- Thrombocytopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carica Papaya Leaf ExtractDrug
Carica Papaya Leaf Extract 1100 mg X TDS started at least 3 days preoperatively and continued on post operative day 3 to day 7
PlaceboOther
Placebo will be given in a similar manner
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
POD 7 Platelet Counts
Measured: 7th post-operative day
Secondary outcomes (4)
Pre-operative platelet counts
Measured: 1 day prior to surgery
Intra-operative blood loss and transfusion requirements
Measured: Day 0
Incidence of Early allograft dysfunction
Measured: First 7 days following live donor liver transplant
Incidence of prolonged post-operative drainage
Measured: First 14 days following live donor liver transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2022
- Study start1 Jan 2021
- Primary completion1 Oct 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThrombocytopeniaStudies of the same condition, open and under way.
- More trials run by Institute of Liver and Biliary Sciences, IndiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Liver and Biliary Sciences, India
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Viniyendra Pamecha, FEBS, Study director, Institute of Liver & Biliary Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05360134
- Sponsor's protocol ID
- ILBS-LDLT-01
- Status last verified
- Apr 2022
- First submitted
- 25 Apr 2022
- Last updated
- 4 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Platelet Augmentation Using Carica Papaya Leaf Extract in Live Donor Liver Transplantation Recipients - a Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05360134
- Acronym / sponsor ID
- ILBS-LDLT-01
- Conditions
- Thrombocytopenia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Institute of Liver and Biliary Sciences, IndiaUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Oct 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 4 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Carica Papaya Arm | Experimental | Drug: Carica Papaya Leaf Extract1100mg of Carica Papaya Leaf extract administered three times daily for upto one week preoperatively and from post-operative day 3 to day 7. |
| Placebo Arm | Placebo comparator | Other: PlaceboPlacebo administered 3 time daily for upto one week preoperatively and from post-operative day 3 to day 7. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All consenting adults who are planned to undergo live donor liver transplant with platelet counts less than or equal to 75000/μL preoperatively.
Key exclusion criteria (6 listed)
- Patients who do not consent
- ALF \& ACLF
- Pediatric transplant recipients
- Allergic to papaya
- Preoperative platelet counts >75,000/ μL
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Carica Papaya Leaf ExtractCarica Papaya Leaf Extract 1100 mg X TDS started at least 3 days preoperatively and continued on post operative day 3 to day 7 | Drug | Carica Papaya Arm |
| PlaceboPlacebo will be given in a similar manner | Other | Placebo Arm |
Primary outcome
POD 7 Platelet Counts
Time frame: 7th post-operative day
4 secondary outcomes
Pre-operative platelet counts
Time frame: 1 day prior to surgery
Intra-operative blood loss and transfusion requirements
Time frame: Day 0
Incidence of Early allograft dysfunction
Time frame: First 7 days following live donor liver transplant
Incidence of prolonged post-operative drainage
Time frame: First 14 days following live donor liver transplant
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Viniyendra Pamecha, FEBS study director
Institute of Liver & Biliary Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Carica Papaya Leaf Extract in people with Thrombocytopenia, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anubhav Harshit Kumar, MCh (8860188337, anubhav.pawar@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
POD 7 Platelet Counts (time frame: 7th post-operative day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2022.