FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2016/11/007421 [Registered on: 02/11/2016] Trial Registered Prospectively
Last Modified On: 03/11/2016
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   An observational study to evaluate drug utilization pattern and adverse drug reaction profile in radiotherapy and oncology section. 
Scientific Title of Study   "Evaluation of Drug Utilization Pattern and Adverse Drug Reaction Profile in Radiotherapy and Oncology section of A Tertiary Health Care teaching hospital: A prospective, observational study" 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ruchika Kalra 
Designation  M.B.B.S., First year resident, Department of Pharmacology, Government Medical College, Bhavnagar 
Affiliation  Government Medical College,Bhavnagar 
Address  1st floor,Pharmacology Department,Government Medical College, Bhavnagar
1st floor,Pharmacology Department,Government Medical College, Bhavnagar
Bhavnagar
GUJARAT
364001
India 
Phone  09772616565  
Fax  0278-24422011  
Email  drruchika@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr CBTripathi 
Designation  Professor and Head, Pharmacology, Government Medical College, Bhavnagar 
Affiliation  Government Medical College,Bhavnagar 
Address  1st floor,Pharmacology Department,Government Medical College, Bhavnagar
1st floor,Pharmacology Department,Government Medical College, Bhavnagar
Bhavnagar
GUJARAT
364001
India 
Phone  09825951678  
Fax  0278-24422011  
Email  cbrtripathi@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Dr CBTripathi 
Designation  Professor and Head, Pharmacology, Government Medical College, Bhavnagar 
Affiliation  Government Medical College,Bhavnagar 
Address  1st floor,Pharmacology Department,Government Medical College, Bhavnagar
1st floor,Pharmacology Department,Government Medical College, Bhavnagar

GUJARAT
364001
India 
Phone  09825951678  
Fax  0278-24422011  
Email  cbrtripathi@yahoo.co.in  
 
Source of Monetary or Material Support  
Department Of Pharmacology, Government Medical College, Bhavnagar (Gujarat).  
 
Primary Sponsor  
Name  Department of Pharmacology Government Medical College Bhavnagar 
Address  First Floor Government Medical College Near ST Bus stand Jail road Bhavnagar-364001 Gujarat 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ruchika Kalra  Government Medical College and Sir Takhtsinhji General Hospital Bhavnagar  Radiotherapy and Oncology section Sir Takhtsinhji General Hospital campus Jail Road Bhavnagar- 36400, Gujarat, India.
Bhavnagar
GUJARAT 		 09772616565
0278-24422011
drruchika@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IRBGMCB  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Adverse drug reaction profile and drug utilization pattern in radiotherapy and oncology section.,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria
Modification(s)  
Age From  1.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1.All the participants undergoing chemotherapy in day care centre during the study time period will be enrolled.
2.All participants receiving anti-cancer regimens, will be included in the study .
3.Participants of any age group
 
 
ExclusionCriteria 
Details  Patients not receiving any kind of cancer chemotherapy 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
•To analyze drug utilization pattern.
•To identify the ADR’s caused by anti-cancer drugs
 		 In morning OPD hours and in evening round ( 3days per week)for 2 year duration. 
 
Secondary Outcome  
Outcome  TimePoints 

•Information of patient like name, age, gender, weight, and address of patient.
•Information of drug, its dose, dosage form, mode of administration and total duration of therapy.
•Treatment according to STG( Standard treatment guidelines) or not.
•To determine ADRs due to multidrug anticancer regimens
and to evaluate its causality , severity, preventability,
whether it is reversible or irreversible and to study drug utilization pattern in cancer patients.
 		 In morning OPD hours and in evening round ( 3days per week)for 2 year duration. 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
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)   01/12/2016 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

The study is meant to determine ADRs due to anticancer regimens and to evaluate its causality , severity, preventability, and to study drug utilization pattern in patients attending day care oncology section.

Ø Study Design- Prospective,observational study.

Ø Duration- 24 months.

Ø Methodology- A prospective analysis of ADR ,drug utilization   pattern of medicines prescribed in the Oncology section  will be  done for 24 months after approval from Institutional Review Board.

a.     For drug utilization pattern all patients will get enrolled.

b.     The participant will be screened during the OPD hours and inwards for suspected ADRs thrice a week.

c.      Consent will be taken if any interventional investigation is done and in a case of children or illiterate people  consent will be taken from a guardian.

d.     All newly diagnosed patients or known cases of cancer,  any type and of  any age group and either gender (including      pregnant women) attending oncology section who will  be prescribed anti-cancer medications having ADR will be   included in the study.

e.      ADRs   noticed  by  the  principal  investigator  or assigned doctors , spontaneously  reported   by patients  or  their  guardian  based  on clinical examination and laboratory  findings  will  be  noted.

Ø ADR’S will be assessed according to

·        Causality assessment by  Naranjo  scale and WHO Scale.

·        Severity assessment will be done by (Modified Hartwig  and Siegel-1992)

·        Preventability  will be assessed by Modified Schumock and

         Thornton scale.  
Close