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CTRI Number  CTRI/2024/03/063478 [Registered on: 04/03/2024] Trial Registered Prospectively
Last Modified On: 29/02/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Medication therapy management services]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Impact of medication related services in patients with tuberculosis and diabetes mellitus 
Scientific Title of Study   Effect of medication therapy management services on clinical, humanistic, and treatment outcomes in tuberculosis patients with type 2 diabetes mellitus: an open-label randomized controlled study  
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 Sonal Sekhar M 
Designation  Associate Professor 
Affiliation  Manipal Academy of Higher Education 
Address  Room No:8 Department of Pharmacy Practice, 4th floor, via MCODS, Kasturba Medical College and Hospital, Manipal Academy of Higher Education, Manipal, Karnataka, India

Udupi
KARNATAKA
576104
India 
Phone  7411338846  
Fax    
Email  sonal.sekhar@manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr Sonal Sekhar M 
Designation  Associate Professor 
Affiliation  Manipal Academy of Higher Education 
Address  Room No:8 Department of Pharmacy Practice, 4th floor, via MCODS, Kasturba Medical College and Hospital, Manipal Academy of Higher Education, Manipal, Karnataka, India

Udupi
KARNATAKA
576104
India 
Phone  7411338846  
Fax    
Email  sonal.sekhar@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Malakapogu Pravachana  
Designation  PhD Research Scholar 
Affiliation  Manipal Academy of Higher Education 
Address  Department of Pharmacy Practice, Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education

Udupi
KARNATAKA
576104
India 
Phone  8897557803  
Fax    
Email  pravachana.mcopsmpl2022@learner.manipal.edu  
 
Source of Monetary or Material Support  
Manipal Academy of Higher Education, Madhav Nagar, Manipal, Karnataka, 576104  
 
Primary Sponsor  
Name  Manipal Academy of Higher Education 
Address  Manipal Academy of Higher Education, Manipal, 576104, Karnataka, India  
Type of Sponsor  Research institution and hospital 
 
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 Sonal Sekhar M  Kasturba Medical College and Hospital, Manipal  Department of Pharmacy Practice, 4th floor, via MCODS, Kasturba Medical College and Hospital, Manipal Academy of Higher Education, Manipal, Karnataka, India
Udupi
KARNATAKA 		 7411338846

sonal.sekhar@manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: A15||Respiratory tuberculosis, (2) ICD-10 Condition: A180||Tuberculosis of bones and joints, (3) ICD-10 Condition: A182||Tuberculous peripheral lymphadenopathy, (4) ICD-10 Condition: A150||Tuberculosis of lung, (5) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Medication therapy management(MTM)   Medication therapy management of tuberculosis(TB) with type 2 diabetes mellitus(T2DM) patients are group of services that optimize Anti tubercular therapy (ATT) along with Anti diabetic therapy outcomes for individual patients (Duration of intervention: from Baseline to one year of follow-up) 
Comparator Agent  Standard of Care for tuberculosis and type 2 diabetes mellitus   Standard of Care for tuberculosis with type 2 diabetes mellitus patients  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. Patients ≥18 years of both gender
2. Newly diagnosed Tuberculosis patients (Pulmonary TB, Extra-pulmonary TB) with Type 2 diabetes mellitus
3. Patients receiving standard treatment regimens for TB and T2DM
4. Patients willing to participate in the study
5. Patients who are able to communicate effectively and who are conscious 
 
ExclusionCriteria 
Details  1. TB relapse or treatment failure patients
2. Patients who refuse to take part in the study
3. Pregnant or lactating women
4. The participants lost to follow-up after discharge, will be excluded  
 
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 
All seven clinical outcomes—the rate of readmission, emergency department visits, mortality rate,
adverse drug events , hospital length of stay , drug-related problems , survival
time —will be analyzed.
Humanistic outcomes: It includes medication adherence.
Treatment outcomes: Treatment completed, cured, treatment failed, died, lost to follow up, not
evaluated, treatment success, prevention of recurrence of TB (patient will be followed up till 1
year) and drug resistance.
 		 After one year of the patient recruitment  
 
Secondary Outcome  
Outcome  TimePoints 
Knowledge, attitude and practice of patients towards self-management of disease.
 		 After one year of the patient recruitment  
Health related quality of life in TB with T2DM patients.  After one year of the patient recruitment  
 
Target Sample Size   Total Sample Size="76"
Sample Size from India="76" 
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)   10/03/2024 
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="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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   Title of the project:  Effect of medication therapy management services on clinical, humanistic and treatment outcomes in tuberculosis patients with type 2 diabetes mellitus: an open label randomized controlled study
Type of Study: Open-label Randomized controlled trial
Aims & objectives : 
Primary objective: 
To investigate the effect of Medication therapy management (MTM) services on clinical, humanistic and treatment outcomes in tuberculosis (TB) patients with type 2 diabetes mellitus(T2DM)
Secondary objectives: 
To investigate the effect of MTM services on knowledge, attitude and practice (KAP) in TB with T2DM patients 
To develop and validate a disease specific questionnaire pertaining to the quality of life in patients with TB and T2DM 
          In this study we are investigating whether providing the medication therapy management services along with the standard of treatment can improve the patients clinical, humanistic and treatment outcomes in TB with T2DM patients.
                     
 
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