Impact of medication related services in patients with tuberculosis and diabetes mellitus

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 - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/03/063478

Enrollment

Registered

2024-03-04

Start date

Unknown

Completion date

Unknown

Last updated

2024-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: A15- Respiratory tuberculosis Health Condition 2: A180- Tuberculosis of bones and joints Health Condition 3: A150- Tuberculosis of lung Health Condition 4: A182- Tuberculous peripheral lymphadenopathy Health Condition 5: E119- Type 2 diabetes mellitus without complications

Interventions

Intervention1: 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 t

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
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. Timepoint: After one year of the patient recruitment	—

Measure

Time frame

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. Timepoint: After one year of the patient recruitment

—

Secondary

Measure	Time frame
Health related quality of life in TB with T2DM patients.Timepoint: After one year of the patient recruitment;Knowledge, attitude and practice of patients towards self-management of disease. Timepoint: After one year of the patient recruitment	—

Countries

India

Contacts

Public ContactMalakapogu Pravachana

Manipal Academy of Higher Education

sonal.sekhar@manipal.edu7411338846

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026