ThrombocytopeniapapayaleafNCT03567798

Thrombocytopenia Induced by Chemotherapy

A study testing UPLAT in people with Thrombocytopenia, run by Socrates School Of Health at 1 site in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

Single blind, randomized, multicentric placebo controlled study to evaluate the efficacy of Study product in patient with Chemotherapy induced thrombocytopenia. The Study is divided into [screening visit (visit 1) > baseline and treatment allocation visit (visit 2) >blood collection (visit 3); treatment compliance… Read more about this study

Who is it for?: Ages 18 to 55 years
Conditions the study is for: Thrombocytopenia
What is being tested?: UPLAT
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 60 participants
Where: 1 siteIndia
Study dates: 18 Jul 2017to 20 Nov 2017
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 55 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Male or female aged between 18-55 years.
Subjects must sign with date an informed consent prior to any evaluation and participation in the trial.
Patients who were confirmed solid tumour and received at least one cycle of chemotherapy prior to screening visit.
Patients with a platelet counts between > 20000 and < 150,000/ml at the time of screening.

Who cannot join

Planning to receive any type of surgery.
Pregnant or lactating women.
Patients with platelet count less than 20000/ml.
Patients with thrombocytopenia presenting with active bleeding.
Patients who have received blood or blood product transfusion during the current illness or during past one week.
Patients with thrombocytopenia purpura (ITP) leukemia, hemophilia or bleeding diathesis.
Participation in another trial with another investigational product

Trial locations and contacts

1 site in 1 country.

India1 site

North East Cancer Centre Hospital and research Institute
Guwahati, Assam, 781023

Other trials in India

About this study

Official title: A Post Marketing Randomized Placebo Controlled Study to Evaluate the Efficacy of Study Product UPLAT® (Carica Papaya Leaf Extract + Tinospora Cardifolia Extract) in the Cancer Patients With Thrombocytopenia Induced by Chemotherapy

Read the detailed description

UPLAT® (Carica papaya leaf Extract + Tinospora cardifolia Extract), is an orally administered dietary supplement for management of thrombocytopenia. Manufactured bySanat Products Ltd.

Throughout study, it will be designated as product A to maintain study blindness at subject end.

Placebo Throughout study, it will be designated as product B to maintain study blindness at subject end.

Dose regimen After meeting the inclusion criteria subject will take 4 units daily (2 in morning and 2 in evening) for 10 days. Patients will be called on Day5th, 10th and 15thfor the Complete blood count (Central lab).

Total blood loss Approximately 8-12 mL

Conditions: Thrombocytopenia
Being tested: UPLAT, Placebo
Medical subject headings: Thrombocytopenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

UPLATDietary supplement
Carica papaya leaf Extract + Tinospora cardifolia Extract
PlaceboOther
Placebo

Study groups in NCT03567798
Study group	Role	What they receive
A	Experimental	UPLAT® (Carica papaya leaf Extract + Tinospora cardifolia Extract Take 4 units daily (2 in morning and 2 in evening) for 10 days Receives: Dietary Supplement: UPLAT
B	Placebo comparator	Placebo Take 4 units daily (2 in morning and 2 in evening) for 10 days Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Increase in the platelet counts from baseline levels to the end of therapy.
Increase in the platelet counts from baseline levels to the end
of therapy.
Measured: Day 15

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 Jul 201720 Nov 2017

First posted26 Jun 2018
Study start18 Jul 2017
Primary completion20 Nov 2017
Study completion20 Nov 2017

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.
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
Model description: Single blind, randomized, multicentric placebo controlled study
Masking: Single blind
Who is masked: Participant
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03567798
Sponsor's protocol ID: SPL/UP/2017/01
Acronym: papayaleaf
Status last verified: Jun 2018
First submitted: 13 Jun 2018
Last updated: 27 Jun 2018
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided: Not Yet Decided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 2
A Clinical Study on Prophylactic RespOnse To hEtrombopag for Secondary Prevention in Anti-Cancer Therapy-induced Thrombocytopeniae
Breast Cancer Patients at High Risk of Chemotherapy-induced Thrombocytopenia (CTIT)
RecruitingPhase 3
A Study of Nipocalimab or Intravenous Immunoglobulin (IVIG) in Pregnancies At Risk of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT)
Thrombocytopenia, Neonatal Alloimmune
RecruitingPhase 2
Study to Assess the Safety and Tolerability of Tafasitamab in Adult Participants With Primary Autoimmune Blood Cell Disorders
Immune Thrombocytopenia
Enrolling by invitationObservational study
Screening for Hematology Branch Protocols
Hematologic Disease and Disorders, Donors
Not yet recruitingEarly Phase 1
A Clinical Study Evaluating the Safety and Preliminary Effectiveness of Induced Pluripotent Stem Cell-derived Platelets in Patients With Thrombocytopenia Caused by Allogeneic Hematopoietic Stem Cell Transplantation
Thrombocytopenia

All Thrombocytopenia trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Post Marketing Randomized Placebo Controlled Study to Evaluate the Efficacy of Study Product UPLAT® (Carica Papaya Leaf Extract + Tinospora Cardifolia Extract) in the Cancer Patients With Thrombocytopenia Induced by Chemotherapy
ClinicalTrials.gov ID: NCT03567798
Acronym / sponsor ID: papayaleaf / SPL/UP/2017/01
Conditions: Thrombocytopenia
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: Socrates School Of HealthIndustry (pharma, biotech, devices)
Study start: 18 Jul 2017 (actual)
Primary completion: 20 Nov 2017 (actual)
Study completion: 20 Nov 2017 (actual)
First posted: 26 Jun 2018 (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.

Detailed description

UPLAT® (Carica papaya leaf Extract + Tinospora cardifolia Extract), is an orally administered dietary supplement for management of thrombocytopenia. Manufactured bySanat Products Ltd.

Throughout study, it will be designated as product A to maintain study blindness at subject end.

Placebo Throughout study, it will be designated as product B to maintain study blindness at subject end.

Total blood loss Approximately 8-12 mL

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2
Model description: Single blind, randomized, multicentric placebo controlled study

Arm	Type	Receives
A	Experimental	Dietary Supplement: UPLATUPLAT® (Carica papaya leaf Extract + Tinospora cardifolia Extract Take 4 units daily (2 in morning and 2 in evening) for 10 days
B	Placebo comparator	Other: PlaceboPlacebo Take 4 units daily (2 in morning and 2 in evening) for 10 days

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (4 listed)

Male or female aged between 18-55 years.
Subjects must sign with date an informed consent prior to any evaluation and participation in the trial.
Patients who were confirmed solid tumour and received at least one cycle of chemotherapy prior to screening visit.
Patients with a platelet counts between > 20000 and < 150,000/ml at the time of screening.

Key exclusion criteria (7 listed)

Planning to receive any type of surgery.
Pregnant or lactating women.
Patients with platelet count less than 20000/ml.
Patients with thrombocytopenia presenting with active bleeding.
Patients who have received blood or blood product transfusion during the current illness or during past one week.

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
UPLATCarica papaya leaf Extract + Tinospora cardifolia Extract	Dietary supplement	A
PlaceboPlacebo	Other	B

Primary outcome

Increase in the platelet counts from baseline levels to the end of therapy.
Time frame: Day 15
Increase in the platelet counts from baseline levels to the end of therapy.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2018.
Individual participant dataSharing planned: Undecided. Not Yet Decided

Related trials for Thrombocytopenia

RecruitingPhase 2
A Clinical Study on Prophylactic RespOnse To hEtrombopag for Secondary Prevention in Anti-Cancer Therapy-induced Thrombocytopeniae
Breast Cancer Patients at High Risk of Chemotherapy-induced Thrombocytopenia (CTIT)
RecruitingPhase 3
A Study of Nipocalimab or Intravenous Immunoglobulin (IVIG) in Pregnancies At Risk of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT)
Thrombocytopenia, Neonatal Alloimmune
RecruitingPhase 2
Study to Assess the Safety and Tolerability of Tafasitamab in Adult Participants With Primary Autoimmune Blood Cell Disorders
Immune Thrombocytopenia
Enrolling by invitationObservational study
Screening for Hematology Branch Protocols
Hematologic Disease and Disorders, Donors
Not yet recruitingEarly Phase 1
A Clinical Study Evaluating the Safety and Preliminary Effectiveness of Induced Pluripotent Stem Cell-derived Platelets in Patients With Thrombocytopenia Caused by Allogeneic Hematopoietic Stem Cell Transplantation
Thrombocytopenia

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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing UPLAT in people with Thrombocytopenia, run by Socrates School Of Health 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 4 inclusion and 7 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: finished, as of the sponsor's last update on 27 Jun 2018. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Increase in the platelet counts from baseline levels to the end of therapy. (time frame: Day 15). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03567798.

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 27 Jun 2018; AzTrials last refreshed its copy on 3 Nov 2026.