| CTRI Number |
CTRI/2017/07/008954 [Registered on: 03/07/2017] Trial Registered Prospectively |
| Last Modified On: |
04/07/2017 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Benefit of carica papaya leaf extract in cancer patients |
|
Scientific Title of Study
|
A Multi-centric, Double blind, Placebo controlled, Randomized, observational study to evaluate the Efficacy, Safety and tolerability of carica papaya leaf Hydro alcoholic extraction with enriched alkaloids (290 mg) to inhibit Thrombocytopenia induced by Chemotherapy in cancer patients |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nagabhushan KH |
| Designation |
Director – Innovation & Implementation |
| Affiliation |
Katra Phytochem Pvt ltd |
| Address |
Katra Phytochem Pvt ltd
Unit : No. 7, A-1, Attibele Industrial Area, Anekal Taluk, Bengaluru Dist. India
Bangalore
KARNATAKA
562107
India |
| Phone |
08023086461 |
| Fax |
|
| Email |
nagabhushandr@katraphyto.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nagabhushan KH |
| Designation |
Director – Innovation & Implementation |
| Affiliation |
Katra Phytochem Pvt ltd |
| Address |
Katra Phytochem Pvt ltd
Unit : No. 7, A-1, Attibele Industrial Area, Anekal Taluk, Bengaluru Dist. India
Bangalore
KARNATAKA
562107
India |
| Phone |
08023086461 |
| Fax |
|
| Email |
nagabhushandr@katraphyto.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Balakrishna |
| Designation |
Research Scientist |
| Affiliation |
Katra Phytochem Pvt ltd |
| Address |
Katra Phytochem Pvt ltd
Unit : No. 7, A-1, Attibele Industrial Area, Anekal Taluk, Bengaluru Dist. India
Bangalore
KARNATAKA
562107
India |
| Phone |
08023086461 |
| Fax |
|
| Email |
balakrishna@katraphyto.com |
|
|
Source of Monetary or Material Support
|
| Katra Phytochem Pvt ltd
Plant No. 7, A-1, Attibele Industrial Area,
Anekal Taluk, Bangalore District - 562107
Karnataka, India |
|
|
Primary Sponsor
|
| Name |
Katra Phytochem Pvt ltd |
| Address |
#1134,1st Floor, 100 ft Road, HAL 2nd Stage, Indiranagar,
Bangalore - 560008, Karnataka, India |
| 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 |
| DrSatheesh C T |
Sri Venkateshwara Hospital |
Sri Venkateshwara Hospital
No.86, Ground Floor OPD Room No 3
Hosur Main Road, Madivala, Bangalore - 560068, Near Ayyappa Temple
Bangalore
KARNATAKA |
8041508702
drsatheeshct@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri venkateshwara Hospital institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Cancer , |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Carica papaya leaf Hydro alcoholic extraction with enriched alkaloids |
Dose: 290mg
Dosage form : Tablets
Frequency: Twice daily
Duration: 21 days |
| Comparator Agent |
Placebo |
Dose: 290mg
Dosage form : Tablets
Frequency: Twice daily
Duration: 21 days |
|
|
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 Platelet count
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 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.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the effect of Papaya Leaf Extract relative to the placebo on the platelet counts |
21 days
Twice daily |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Percentage increase in WBC,RBC and Neutrophil count
Number of chemotherapy dose reduction |
21 days
Twice daily |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
04/07/2017 |
| 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="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
No |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Carica papayaleaf extract has attracted attentions because of the promising results shown from the various studies conducted in South East Asian countries on the effectiveness of carica papayaleaf extract on increasing the platelet counts in patients with thrombocytopenia This trial is designed as Multi-centric, double blind, placebo controlled, Randomized, Prospective study in patients aged 18 years and above and having thrombocytopenia associated with anti cancer chemotherapy |