Thrombocytopenia Induced by Chemotherapy

Thrombocytopenia Clinical Trial

— papayaleaf  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03567798
• Other study ID #: SPL/UP/2017/01
• Status: Completed
• Phase: N/A
• Start date: July 18, 2017
• Est. completion date: November 20, 2017

Study information

• Verified date: June 2018
• Source: Socrates School Of Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)].

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 20, 2017
• Est. primary completion date: November 20, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Thrombocytopenia

Intervention

Dietary Supplement:
• UPLAT
Carica papaya leaf Extract + Tinospora cardifolia Extract

Other:
• Placebo
Placebo

Locations

Country	Name	City	State
India	North East Cancer Centre Hospital and research Institute	Guwahati	Assam

Sponsors (1)

Lead Sponsor	Collaborator
Socrates School Of Health

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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