| CTRI Number |
CTRI/2018/01/011144 [Registered on: 04/01/2018] Trial Registered Retrospectively |
| Last Modified On: |
03/01/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
clinical trial on Papaya leaf extract in cancer patients for increasing platelet let counts |
|
Scientific Title of Study
|
A Prospective, Placebo Controlled Study on Caripill Tablet in Management of
Chemotherapy induced Thrombocytopenia in solid tumors |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrManjula S |
| Designation |
Vice president -Medical services |
| Affiliation |
Micro labs Ltd |
| Address |
No 27 Race course Road Bangalore Karnataka India No 27 Race
course Road Bangalore Karnataka India
Bangalore
KARNATAKA
560001
India
Bangalore
KARNATAKA
560001
India |
| Phone |
|
| Fax |
|
| Email |
drmanjula@microlabs.in |
|
Details of Contact Person
Scientific Query
|
| Name |
DrManjula S |
| Designation |
Vice president -Medical services |
| Affiliation |
Micro labs Ltd |
| Address |
No 27 Race course Road Bangalore Karnataka India No 27 Race
course Road Bangalore Karnataka India
Bangalore
KARNATAKA
560001
India
KARNATAKA
560001
India |
| Phone |
|
| Fax |
|
| Email |
drmanjula@microlabs.in |
|
Details of Contact Person
Public Query
|
| Name |
DrKrishna kumar |
| Designation |
Manager-Medical services |
| Affiliation |
Micro labs Ltd |
| Address |
No 27 Race course Road Bangalore Karnataka India No 27 Race
course Road Bangalore Karnataka India
Bangalore
KARNATAKA
560001
India
Bangalore
KARNATAKA
560001
India |
| Phone |
9916043259 |
| Fax |
|
| Email |
krishna@microlabs.in |
|
|
Source of Monetary or Material Support
|
| Micro Labs Limited
No 27 Race course road
Bangalore, Karnataka -560001 |
|
|
Primary Sponsor
|
| Name |
Micro Labs Ltd |
| Address |
No 27 Race course road Bangalore, Karnataka, 560001 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Radheshyam Naik |
Healthcare Global Enterprises Limited |
#8, HCG Towers,
Tower IV, 5th Floor,
P.Kalinga Rao Road,
Sampangi Ram Nagar,
Bangalore - 560 027
Bangalore
KARNATAKA
Bangalore
KARNATAKA |
8033466171
radheshyam_n@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| HCG – Central Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Thrombocytopenia in solid tumors, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
caripill (Papaya leaf extract 1100 mg) tablet |
through out chemotherapy cycle |
| Comparator Agent |
Placebo (starch 1100mg) |
Through out chemotherapy cycle |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
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
|
|
| ExclusionCriteria |
| Details |
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
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
primary objective of this study is to evaluate the efficacy of CARIPILL
Tablet in adult patients with grade I to grade III chemotherapy induced
thrombocytopenia (CIT) in solid tumors by assessing the response of platelet
count relative to the placebo group. |
Through out chemotherapy cycle |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to evaluate WBS and RBC count |
Through out chemotherapy cycle |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
19/09/2016 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The primary objective of this study is to evaluate the efficacy of CARIPILL Tablet in adult patients with grade I to grade III chemotherapy induced thrombocytopenia (CIT) in solid tumors by assessing the response of platelet count relative to the placebo group
Thrombocytopenia is a common problem in patients with cancer. It can result from chemotherapy or radiation or from underlying disease. Thrombocytopenia creates number of problems in the care of a cancer patients like increased spontaneous bleeding, surgical procedure might be complicated by bleeding, reduction of the dose and intensity of chemotherapy or radiation may be required, effective regimens might be avoided due to the fear of worsening of thrombocytopenia and sometimes treatment might be even be precluded.
The phytochemical analysis of the papaya leaves has shown that they contain saponins, cardiac glycosides, and alkaloids. C. papaya Leaves are a rich source of mineral elements such as Ca, Mg, Na, K, Fe, and Mn. The therapeutic effects of aqueous extract of papaya (Carica papaya) leaves are presumed to be due to several active components such as papain, chymopapain, cystatin, L-tocopherol, ascorbic acid, flavonoids, cyanogenic glucosides and glucosinolates. These are antioxidants that reduce lipid peroxidation, exhibit antitumor activity and immune modulatory effects
|