Health Condition 1: C801- Malignant (primary) neoplasm, unspecified
Conditions
Interventions
Intervention1: Caripap PE along with Standard of Care treatment: Drug: Carica papaya Leaf Extract plus Cucurbita pepo Seed Extract
Dose: 1200 mg
Dosage form: Tablets
Duration: 3 Tablets per day after
Sponsors
Med Manor Organics Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subjects of both genders aged between 18 to 75 years. 2. Subjects undergoing chemotherapy for non hematological malignancies. 3. Willing and able to sign written informed consent
Exclusion criteria
Exclusion criteria: 1. Present or past history of acute pro-myelocytic leukemia (APML), immune thrombocytopenic purpura (ITP), thrombotic thrombocytopenic purpura (TTP), or hemolytic-uremic syndrome (HUS). 2. Recent history of major surgery (within 2 weeks of study entry). 3. Currently taking, or participating in a study involving, platelet substitutes, platelet growth factors, or pharmacologic agents intended to enhance or decrease platelet hemostatic function. 4. Received high-dose steroids or IVIG in the 3 weeks prior to the start of the study. 5. Current HIV infection or hepatitis B virus or hepatitis C virus infections. 6. Severe medical condition (lung, hepatic or renal disorder) other than chronic ITP. 7. Unstable or uncontrolled disease or condition related to or impacting cardiac function (e.g., unstable angina, congestive heart failure, uncontrolled hypertension or cardiac arrhythmia). 8. Female subjects who are nursing or pregnant, who may be pregnant, or who contemplate pregnancy during the study period. 9. Subjects with known diagnosis of autoimmune diseases, established in the medical history and / or laboratory findings with positive results for the determination of antinuclear antibodies, anti-cardiolipin antibodies, lupus anticoagulant or direct Coombs test. 10. Subjects who are deemed unsuitable for the study by the investigator. 11. Subjects with palpable splenomegaly =16 cm below subcostal margin. 12. Female subjects who are pregnant or breastfeeding. Women of childbearing potential are required to have a urine pregnancy test or serum ß-HCG performed within 3 days prior to first study drug dose. A female subject of childbearing potential is a sexually mature woman who has not undergone a hysterectomy or bilateral oophorectomy; or has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months. Women of child-bearing potential and men must agree to use contraception prior to study entry and for the duration of study participation. 13. Subjects who had previously enrolled in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.The primary objective of this study is to evaluate the efficacy of Caripap-PE in adult subjects with Grade I to III thrombocytopenia due to chemotherapy-induced thrombocytopenia (CIT) in solid tumours by assessing the response of platelet count relative to the placebo group.Timepoint: Day 0 to Day 21 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The ability of the subject to complete at least two successive cycles of chemotherapy without further evidence of treatment-limiting thrombocytopenia such as chemotherapy dose reduction & delays. 2. To compare the number of platelet transfusions episodes the subjects would undergo after starting Caripap-PE relative to the placebo group 3. The percentage of change in WBC and Neutrophil count from baseline value and after Caripap-PE treatment relative to the placebo group 4. Number of subjects with adverse events during the Caripap-PE treatment cycles. Timepoint: Day 0 to Day 21 | — |
Countries
India
Contacts
Public ContactMrRavikumar S
Med Manor Organics Private Limited
Outcome results
None listed