Thrombocytopenia Induced by Chemotherapy | NCT03567798

Studies
Thrombocytopenia Induced by Chemotherapy

NCT03567798

Sponsor

Socrates School Of Health

Status

Completed

Last Update Posted

Jun 27, 2018Actual

Enrollment

60Actual

Phase

Not Applicable

Conditions

Thrombocytopenia

Interventions

UPLAT
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

Jun 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 18, 2017Actual

Primary Completion Date

Nov 20, 2017Actual

Completion Date

Nov 20, 2017Actual

First Submitted Date

Jun 13, 2018

First Submission Date that Met QC Criteria

Jun 13, 2018

First Posted Date

Jun 26, 2018Actual

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

Jun 25, 2018

Last Update Posted Date

Jun 27, 2018Actual

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

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 visit (visit 4) > blood collection (visit 5) >blood collection (visit 6)>end of study visit (visit 7)].

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

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

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A	Experimental	UPLAT® (Carica papaya leaf Extract + Tinospora cardifolia Extract Take 4 units daily (2 in morning and 2 in evening) for 10 days	Dietary Supplement: UPLAT
B	Placebo Comparator	Placebo Take 4 units daily (2 in morning and 2 in evening) for 10 days	Other: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
UPLAT	Dietary Supplement	Carica papaya leaf Extract + Tinospora cardifolia Extract	A

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	Day 15

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
North East Cancer Centre Hospital and research Institute		Guwahati	Assam	781023	India

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not Yet Decided

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

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Browse Branches

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