Thrombocytopenia Induced by Chemotherapy

Not Applicable

Completed

• Conditions: Thrombocytopenia
• Interventions: Other: Placebo; Dietary Supplement: UPLAT

• Registration Number: NCT03567798
• Lead Sponsor: Socrates School Of Health

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

Study Timeline

• Study Start: 2017-07-18
• Primary Completion: 2017-11-20
• Study Completion: 2017-11-20
• Status Verified: 2018-06
• Study First Submitted: 2018-06-13
• Study First Submitted QC: 2018-06-13
• Last Update Submitted: 2018-06-25
• Study First Posted: 2018-06-26
• Last Update Posted: 2018-06-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B	Placebo	Placebo Take 4 units daily (2 in morning and 2 in evening) for 10 days
A	UPLAT	UPLAT® (Carica papaya leaf Extract + Tinospora cardifolia Extract Take 4 units daily (2 in morning and 2 in evening) for 10 days

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

North East Cancer Centre Hospital and research Institute; 🇮🇳 Guwahati, Assam, India