| CTRI Number |
CTRI/2025/03/081628 [Registered on: 04/03/2025] Trial Registered Prospectively |
| Last Modified On: |
25/02/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To Study The Effect of Papaya Leaf On Platelet Count In Ovarian Cancer Patients Given Chemotherapy |
|
Scientific Title of Study
|
Evaluation the Therapeutic and Molecular Effect of Carica Papaya aqueous Leaf Extract On Platelet Count in Chemotherapy -induced Thrombocytopenia in Ovarian Cancer Patients
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr. Anurag Srivastava |
| Designation |
Director Oncology |
| Affiliation |
Professor and Director oncology Department |
| Address |
Swami Vivekananda Subharti University NH-58 Delhi Haridwar Bypass Road Subhartipuram, Meerut
same as address 1
Meerut
UTTAR PRADESH
250005
India |
| Phone |
09868397729 |
| Fax |
|
| Email |
dr.anuragsrivastava@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
ANURAG SRIVASTAVA |
| Designation |
Director Oncology |
| Affiliation |
Professor and Director oncology Department |
| Address |
Swami Vivekananda Subharti University NH-58 Delhi Haridwar Bypass Road Subhartipuram, Meerut
same as address 1
Meerut
UTTAR PRADESH
250005
India |
| Phone |
09868397729 |
| Fax |
|
| Email |
dr.anuragsrivastava@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
ANURAG SRIVASTAVA |
| Designation |
Director Oncology |
| Affiliation |
Professor and Director oncology Department |
| Address |
Swami Vivekananda Subharti University NH-58 Delhi Haridwar Bypass Road Subhartipuram, Meerut
same as address 1
Meerut
UTTAR PRADESH
250005
India |
| Phone |
09868397729 |
| Fax |
|
| Email |
dr.anuragsrivastava@gmail.com |
|
|
Source of Monetary or Material Support
|
| Swami Vivekananda Subharti University NH-58 Delhi Haridwar Bypass Road Subhartipuram, Meerut, 250005, Uttar Pradesh, India |
|
|
Primary Sponsor
|
| Name |
Ministry of Ayush |
| Address |
CCRAS New Delhi |
| Type of Sponsor |
Research institution |
|
|
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 Anurag Srivastava |
subharti medical college |
oncology ward, general opd oncology Dept., Subharti Medical college, Meerut
Meerut
UTTAR PRADESH |
9868397729
dr.anuragsrivastava@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| UNIVERSITY ETHICS COMMITTEE MEDICAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D696||Thrombocytopenia, unspecified, (2) ICD-10 Condition:N838||Other noninflammatory disorders ofovary, fallopian tube and broad ligament. Ayurveda Condition: ARBUDAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Caripill, Reference: NA, Route: Oral, Dosage Form: Capsules, Dose: 1100(mg), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: 1100 mg , 3 times a DAY WOULD BE GIVEN FOR 7 DAYS | | 2 | Comparator Arm (Non Ayurveda) | | - | control | without any intervention |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Female |
| Details |
Patients with platelet count 30000-1.5 lakhs |
|
| ExclusionCriteria |
| Details |
Pregnant and lactating female
liver and kidney dysfunction |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Rise in platelet count will be observed |
7th and 16th day post chemotherapy |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Rise in RBC & WBC will be observed |
7th & 16th day post chemotherapy |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
12/03/2025 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Background:
Chemotherapy-induced
thrombocytopenia (CIT) is one of the commonest side effects of cancer
chemotherapy. A number of drugs have been tried, but all of them are associated
with adverse effects. Studies show that Carica papaya leaf extracts
(CPLE) over expresses arachidonate 12-lipoxygenase (ALOX-12) and
platelet-activating factor receptor gene which stimulates the megakaryopoiesis.
Aims and
Objectives: To evaluate the efficacy and safety of CPLE in CIT in cancer patients.
Materials and
Methods:
Drug administration:
A total of 80 patients diagnosed to have CIT after cancer chemotherapy will be randomized into two groups of 40 subjects each. Interventional group will receive CPLE 1100 mg TID for 7 days
post chemotherapy day 7-14 and the non-interventional group will be control group, without any intervention.
Complete
hemogram will be done at post chemotherapy day7±4 and 16±4.
Patients will be
followed up for 15 days for appearance of any adverse effects.
Statistical
analysis will be done to achieve a conclusion.
Molecular Testing:
EDTA Blood
collection, plasma isolation and qPCR analysis and in-silico studies will be
done for arachidonate 12-lipoxygenase (ALOX 12) and platelet-activating factor
receptor (PTAFR) genes. It will be done on 10 cases from the both arm,
interventional and non-interventional group.
Expected outcome: Safety and efficacy of the drug will be observed, which
will be validated by gene expression in plasma. |