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CTRI Number  CTRI/2016/07/007074 [Registered on: 12/07/2016] Trial Registered Retrospectively
Last Modified On: 06/04/2016
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   "Evaluation of the factors affecting adherence to medicines among the patients of Diabetes Mellitus in a Northern India hospital” 
Scientific Title of Study   "Evaluation of the factors affecting compliance among the diabetic patients in a Tertiary Level Care Teaching Hospital in Northern India” 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
U1111-1169-7289  UTN 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Prashant 
Designation  Junior Resident 
Affiliation  Government Medical College 
Address  Department of Pharmacology Government Medical College Patiala Punjab

Patiala
PUNJAB
147001
India 
Phone  8427258812  
Fax    
Email  cool1988pacific@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Anita Gupta 
Designation  Professor & Head 
Affiliation  Government Medical College 
Address  Department of Pharmacology Government Medical College Patiala Punjab

Patiala
PUNJAB
147001
India 
Phone  8427258812  
Fax    
Email  drguptaanita@outlook.com  
 
Details of Contact Person
Public Query  
Name  Dr Prashant 
Designation  Junior Resident 
Affiliation  Government Medical College 
Address  Department of Pharmacology Government Medical College Patiala Punjab


PUNJAB
147001
India 
Phone  8427258812  
Fax    
Email  cool1988pacific@gmail.com  
 
Source of Monetary or Material Support  
Government Medical College Patiala 
 
Primary Sponsor  
Name  Government Medical College Patiala 
Address  Rajindra Hospital Government Medical College Patiala 
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 Prashant  Rajindra Hospital  Room No 14, Medicine department, Rajindra Hospital Government Medical College Patiala
Patiala
PUNJAB 		 8427258812

cool1988pacific@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ETHICAL COMMITTEE GOVT. MEDICAL COLLEGE, PATIALA  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Diabetes Mellitus (Type 1 and 2),  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1) Age ≥18 years of age;
2) having type 1 DM/ type 2 DM;
3) providing informed consents; and
4) having diabetes for at least one year.
 
 
ExclusionCriteria 
Details  1) Patients with severe cognitive problems.
2) Lack of patient’s consent to participate in the study.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Monitoring of HbA1C levels  At the time of recruitment (Day 0) 
 
Secondary Outcome  
Outcome  TimePoints 
Monitoring various factors affecting the level of HbA1C  At the time of recruitment (Day 0) 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   19/06/2015 
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)  Open to Recruitment 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   Compliance of patients is a major problem in the management of chronic diseases like Diabetes mellitus. Various factors related with the compromise in the compliance of patients are cost, frequency and side effects of medications as well as the awareness about the complications of the disease. The study will be aimed at investigating the various other factors affecting compliance among the diabetic patients in Northern India. It will be a questionnaire-based cross-sectional study. Questionnaires will be administered to the patients attending Medicine department at Rajindra Hospital, Government Medical College, Patiala. All the observations made will be statistically analysed using appropriate tests. 
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