Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2017-07-18
2017-11-20
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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A
UPLAT® (Carica papaya leaf Extract + Tinospora cardifolia Extract
Take 4 units daily (2 in morning and 2 in evening) for 10 days
UPLAT
Carica papaya leaf Extract + Tinospora cardifolia Extract
B
Placebo
Take 4 units daily (2 in morning and 2 in evening) for 10 days
Placebo
Placebo
Interventions
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UPLAT
Carica papaya leaf Extract + Tinospora cardifolia Extract
Placebo
Placebo
Eligibility Criteria
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Inclusion Criteria
2. Subjects must sign with date an informed consent prior to any evaluation and participation in the trial.
3. Patients who were confirmed solid tumour and received at least one cycle of chemotherapy prior to screening visit.
4. Patients with a platelet counts between \> 20000 and \< 150,000/ml at the time of screening.
Exclusion Criteria
2. Pregnant or lactating women.
3. Patients with platelet count less than 20000/ml.
4. Patients with thrombocytopenia presenting with active bleeding.
5. Patients who have received blood or blood product transfusion during the current illness or during past one week.
6. Patients with thrombocytopenia purpura (ITP) leukemia, hemophilia or bleeding diathesis.
7. Participation in another trial with another investigational product
18 Years
55 Years
ALL
No
Sponsors
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Socrates School Of Health
INDUSTRY
Responsible Party
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Locations
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North East Cancer Centre Hospital and research Institute
Guwahati, Assam, India
Countries
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Other Identifiers
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SPL/UP/2017/01
Identifier Type: -
Identifier Source: org_study_id
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