Thrombocytopenia Induced by Chemotherapy (papayaleaf)

Socrates Schools of Health

Status: Completed

Conditions: Thrombocytopenia

Treatments: Other: Placebo; Dietary Supplement: UPLAT

Study type: Interventional

Funder types: Industry

Identifiers

NCT03567798

SPL/UP/2017/01

Details and patient eligibility

About

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)].

Full 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

Enrollment: 60 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups, including a placebo group

A

Experimental group

Description:

UPLAT® (Carica papaya leaf Extract + Tinospora cardifolia Extract Take 4 units daily (2 in morning and 2 in evening) for 10 days

Treatment:

Dietary Supplement: UPLAT

B

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo