Thrombocytopenia Induced by Chemotherapy (papayaleaf)

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)].

Study Overview

• Status: Completed
• Conditions: Thrombocytopenia
• Intervention / Treatment: Other: Placebo; Dietary supplement: UPLAT

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

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Assam
    • Guwahati, Assam, India, 781023
      • North East Cancer Centre Hospital and research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 53 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Socrates School Of Health

Study record dates

Study Major Dates

• Study Start (Actual): July 18, 2017
• Primary Completion (Actual): November 20, 2017
• Study Completion (Actual): November 20, 2017

Study Registration Dates

• First Submitted: June 13, 2018
• First Submitted That Met QC Criteria: June 13, 2018
• First Posted (Actual): June 26, 2018

Study Record Updates

• Last Update Posted (Actual): June 27, 2018
• Last Update Submitted That Met QC Criteria: June 25, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hematologic Diseases; Blood Platelet Disorders; Thrombocytopenia
• Other Study ID Numbers: SPL/UP/2017/01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: Not Yet Decided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No