Thrombocytopenia Induced by Chemotherapy

Study Overview
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Brief Summary
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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
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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

Official Title
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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

Conditions
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Thrombocytopenia

Intervention / Treatment
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* Dietary Supplement: UPLAT
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Single blind, randomized, multicentric placebo controlled study
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>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<br>* Carica papaya leaf Extract + Tinospora cardifolia Extract<br>|
| Placebo Comparator: B<br>Placebo Take 4 units daily (2 in morning and 2 in evening) for 10 days | Other: Placebo<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 |