clinical trial on Papaya leaf extract in cancer patients for increasing platelet let counts

Recruitment & Eligibility

Status: Closed to Recruitment of Participants

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1. Age between 18-75 years

2. Has, grade I to Grade III thrombocytopenia as per CTCAE criteria version 4.0

3. Patients undergoing chemotherapy

4. Patients with non-hematological malignancies

5. Willing and able to sign written informed consent

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

Patients who are deemed unsuitable for the study by the investigator

9. Patients with palpable splenomegaly greter than or equalto 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:

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.

11. Previously enrolled in this study

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
primary objective of this study is to evaluate the efficacy of CARIPILL <br/ ><br>Tablet in adult patients with grade I to grade III chemotherapy induced <br/ ><br>thrombocytopenia (CIT) in solid tumors by assessing the response of platelet <br/ ><br>count relative to the placebo group.Timepoint: Through out chemotherapy cycle

Secondary Outcome Measures

Name	Time	Method
to evaluate WBS and RBC countTimepoint: Through out chemotherapy cycle

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