Thrombocytopenia Induced by Chemotherapy

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03567798

Acronym

papayaleaf

Enrollment

Registered

2018-06-26

Start date

2017-07-18

Completion date

2017-11-20

Last updated

2018-06-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thrombocytopenia

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

Interventions

DIETARY_SUPPLEMENTUPLAT

Carica papaya leaf Extract + Tinospora cardifolia Extract

OTHERPlacebo

Placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Masking description

Single Blind

Intervention model description

Single blind, randomized, multicentric placebo controlled study

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Inclusion criteria

1. Male or female aged between 18-55 years. 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

1. Planning to receive any type of surgery. 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

Design outcomes

Primary

Measure	Time frame	Description
Increase in the platelet counts from baseline levels to the end of therapy.	Day 15	Increase in the platelet counts from baseline levels to the end of therapy.

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026