Health Condition 1: null- Cancer
Conditions
Interventions
Intervention1: Carica papaya leaf Hydro alcoholic extraction with enriched alkaloids: Dose: 290mg
Dosage form : Tablets
Frequency: Twice daily
Duration: 21 days
Control Intervention1: Placebo: Do
Sponsors
Katra Phytochem Pvt ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age between 18-75 years 2. Has, Grade I to Grade III thrombocytopenia as per CTCAE criteria version 4.0 Platelet count 3. Patients undergoing chemotherapy 4. Patients with non-hematological malignancies 5. Willing and able to sign written informed consent
Exclusion criteria
Exclusion criteria: 1. Present, or 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. Unstable or uncontrolled disease or condition related to or impacting cardiac function (e.g., unstable angina, congestive heart failure, uncontrolled hypertension or cardiac arrhythmia) 7. Female patients who are nursing or pregnant, who may be pregnant, or who contemplate pregnancy during the study period 8. Have a known diagnosis of other autoimmune diseases, established in the medical history and laboratory findings with positive results for the determination of antinuclear antibodies, anti-cardiolipin antibodies, lupus anticoagulant or direct Coombs test 8.Patients who are deemed unsuitable for the study by the investigator 9. Patients with palpable splenomegaly greter than or equal to 16cm below coastal margin 10. Female subjects who are pregnant or breastfeeding. Women of childbearing potential are required to have a BHCG serum or urine pregnancy test performed within 7 days prior to first study drug dose. A female of childbearing potential is a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the effect of Papaya Leaf Extract relative to the placebo on the platelet countsTimepoint: 21 days Twice daily | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage increase in WBC,RBC and Neutrophil count Number of chemotherapy dose reductionTimepoint: 21 days Twice daily | — |
Countries
India
Contacts
Public ContactDr Balakrishna
Katra Phytochem Pvt ltd
Outcome results
None listed