Back to resultsThrombocytopenia Induced by Chemotherapy (papayaleaf)
Primary Purpose
Thrombocytopenia
Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
UPLAT
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Thrombocytopenia
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
Sites / Locations
- North East Cancer Centre Hospital and research Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
A
B
Arm Description
UPLAT® (Carica papaya leaf Extract + Tinospora cardifolia Extract Take 4 units daily (2 in morning and 2 in evening) for 10 days
Placebo Take 4 units daily (2 in morning and 2 in evening) for 10 days
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03567798
Brief Title
Thrombocytopenia Induced by Chemotherapy
Acronym
papayaleaf
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
July 18, 2017 (Actual)
Primary Completion Date
November 20, 2017 (Actual)
Study Completion Date
November 20, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Socrates School Of Health
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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)].
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thrombocytopenia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Single blind, randomized, multicentric placebo controlled study
Masking
Participant
Masking Description
Single Blind
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Arm Description
UPLAT® (Carica papaya leaf Extract + Tinospora cardifolia Extract
Take 4 units daily (2 in morning and 2 in evening) for 10 days
Arm Title
B
Arm Type
Placebo Comparator
Arm Description
Placebo
Take 4 units daily (2 in morning and 2 in evening) for 10 days
Intervention Type
Dietary Supplement
Intervention Name(s)
UPLAT
Intervention Description
Carica papaya leaf Extract + Tinospora cardifolia Extract
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Increase in the platelet counts from baseline levels to the end of therapy.
Description
Increase in the platelet counts from baseline levels to the end
of therapy.
Time Frame
Day 15
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
North East Cancer Centre Hospital and research Institute
City
Guwahati
State/Province
Assam
ZIP/Postal Code
781023
Country
India
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
Not Yet Decided
Learn more about this trial
Thrombocytopenia Induced by Chemotherapy
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