Thrombocytopenia Clinical Trial
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
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)].
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
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