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CTRI Number  CTRI/2024/01/061820 [Registered on: 24/01/2024] Trial Registered Prospectively
Last Modified On: 24/02/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Patient Counselling]  
Study Design  Other 
Public Title of Study   Optimizing Medication Utilization and Blood Sugar Control through Pharmacy Counseling 
Scientific Title of Study   Assessment of the effect of Pharmacist-Led Education Program on Medication Adherence and Glycemic Control in a Community -setting 
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 Yogendra Shrestha 
Designation  Associate Professor 
Affiliation  Seven Hills College of Pharmacy (Autonomus) 
Address  Department of Pharmacy Practice, Venkatramapuram, Tirupathi

Chittoor
ANDHRA PRADESH
517561
India 
Phone  7348944358  
Fax    
Email  dryogendrastha@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Tapala Shamitha  
Designation  Student 
Affiliation  Seven Hills College of Pharmacy (Autonomus) 
Address  Department of Pharmacy Practice, Venkatramapuram, Tirupathi

Chittoor
ANDHRA PRADESH
517561
India 
Phone  6302698949  
Fax    
Email  shamitha2101@gmail.com  
 
Details of Contact Person
Public Query
 
Name  B Sruthi Selva Kumari 
Designation  Student 
Affiliation  Seven Hills College of Pharmacy (Autonomus) 
Address  Department of Pharmacy Practice, Venkatramapuram, Tirupathi

Chittoor
ANDHRA PRADESH
517561
India 
Phone  9345744396  
Fax    
Email  sruthi8112001selva@gmail.com  
 
Source of Monetary or Material Support  
Seven Hills College of Pharmacy 
 
Primary Sponsor  
Name  Seven Hills College of Pharmacy 
Address  Venkatramapuram, Tirupathi, Andhra Pradesh, India--517561 
Type of Sponsor  Research institution 
 
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 Yogendra Shrestha  Sri Venkateswara Institute of Medical Sciences  Department of Pharmacy Practice, seven Hill College of Pharmacy (Autonomous, Venkatramapuram, Tirupati
Chittoor
ANDHRA PRADESH 
7348944358

dryogendrastha@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Sri Venkateswara Institute of Medical Sciences, Tirumala  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Patient counselling with standard treatment  Patients counselling will be given to a group along with standard treatment prescribed by treating physician 
Comparator Agent  standard treatment without patient counselling  Patients counselling will not be given to a group along with standard treatment prescribed by treating physician. 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  95.00 Year(s)
Gender  Both 
Details  1. Participants were aged 20 years and older.
2. Patients with a confirmed diagnosis of Type-2 Diabetes Mellitus (DM) and are currently on medication
3. Patients who express a willingness to participate in the study
 
 
ExclusionCriteria 
Details  1. Individuals with serious renal conditions
2. Those with hepatic dysfunction
3. Pregnant women.
4. Patients experiencing uncontrolled glycaemic conditions.
5. Individuals with hearing or vision impairments and psychological problems
6.Patients diagnosed with Type-1 diabetes mellitus and gestational diabetes
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1. The study can establish the importance of patient counselling in medical adherence and glycemic control.
2. The study can help to design the strategy to promote medication adherence.
 
6 months 
 
Secondary Outcome  
Outcome  TimePoints 
1. The study can help to design the strategy to promote medication adherence.   6 months 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" 
Phase of Trial   N/A 
Date of First Enrollment (India)   02/02/2024 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="1" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
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  

Diabetes has become a substantial clinical and public health concern on a global scale, affecting approximately 422 million individuals, equating to a prevalence of 8.5%. India, with over 62 million cases, stands as the second-highest contributor to the global diabetes burden after China, resulting in approximately 1 million annual fatalities. According to the World Health Organization (WHO), diabetes currently holds the ninth position among the leading causes of death globally. Projections suggest that by the year 2030, diabetes may ascend to become the seventh most prevalent cause of mortality. This underscores the increasing significance of diabetes as a public health concern and emphasizes the need for proactive measures to address and mitigate its impact on global health.

Effective control of blood sugar levels via appropriate pharmacotherapy is intricately linked to a substantial decrease in complications associated with diabetes. However, ensuring the success of such pharmacotherapy relies heavily on patient adherence to the prescribed medication regimen. Unfortunately, there is a growing concern as patients exhibit non-adherence behaviours, often discontinuing prescribed medications in favour of alternative remedies as highlighted in recent media reports. This shift in medication practices has been observed to correlate with an alarming increase in both mortality and morbidity rates associated with diabetes. This phenomenon underscores the critical need for a scientific exploration of the factors influencing patient adherence and a comprehensive understanding of the consequences, ultimately guiding strategies to mitigate the adverse impacts on diabetes outcomes. 

 
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