Thrombocytopenia Induced by Chemotherapy

NCT03567798 | Completed

• 1 other identifier: SPL/UP/2017/01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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 \[screening visit (visit 1) \> baseline and treatment allocation visit (visit 2) \>blood collection (visit 3); treatment compliance visit (visit 4) \> blood collection (visit 5) \>blood collection (visit 6)\>end of study visit (visit 7)\].

Conditions

Thrombocytopenia

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

A

EXPERIMENTAL

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

B

PLACEBO COMPARATOR

Placebo Take 4 units daily (2 in morning and 2 in evening) for 10 days

Other: Placebo

Interventions

UPLAT DIETARY_SUPPLEMENT

Carica papaya leaf Extract + Tinospora cardifolia Extract

A

Placebo OTHER

Placebo

B

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Socrates School Of Health: lead

Study Sites (1)

North East Cancer Centre Hospital and research Institute

Guwahati, Assam, 781023, India

Location

MeSH Terms

Conditions

Thrombocytopenia

Condition Hierarchy (Ancestors)

Blood Platelet Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Cytopenia

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Single Blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single blind, randomized, multicentric placebo controlled study

Study Record Dates

• First Submitted: June 13, 2018
• First Posted: June 26, 2018
• Study Start: July 18, 2017
• Primary Completion: November 20, 2017
• Study Completion: November 20, 2017
• Last Updated: June 27, 2018

Record last verified: 2018-06

Locations

IN (1)