Anti-inflammatory strategies for cachexia in tuberculosis

Overcoming the anabolic block in patients with tuberculosis with a focus on cachexia through anti-inflammatory strategies in south India: a randomized controlled trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/11/097293

Enrollment

210

Registered

2025-11-13

Start date

Unknown

Completion date

Unknown

Last updated

2025-11-17

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

Conditions

Health Condition 1: A150- Tuberculosis of lung

Interventions

Intervention1: Ibuprofen: This arm will receive 400mg ibuprofen twice a day for the 1st 4 weeks followed by 400mg ibuprofen once a day for the next 8 weeks, placebo comprising a corn oil capsule twice

Eligibility

Inclusion criteria

Inclusion criteria: 1. ATT naive patients with drug sensitive Pulmonary TB 2. BMI of less than 18.5kg/m2 3. Karnofsky score more than 70 4. Willing to comply with study procedures 5. Willing to adhere to study visits

Exclusion criteria

Exclusion criteria: 1. Diagnosed with Diabetes mellitus 2. Diagnosed with HIV infection 3. Diagnosed with coagulation defects 4. Existing or newly diagnosed renal conditions 5. Pregnancy 6. Patients with TB from the same household 7. Persons unable to comprehend the study procedures and requirements

Design outcomes

Primary

Measure	Time frame
The primary outcome is the change in creatine phosphokinase (mCK) fractional synthesis rate (FSR) from baseline to 12 weeks Timepoint: The primary outcome is the change in creatine phosphokinase (mCK) fractional synthesis rate (FSR) from baseline to 12 weeks	—

Secondary

Measure	Time frame
Proportion of change in cachexia in three armsTimepoint: 12 weeks and 24 weeks (from baseline);Change in quality of lifeTimepoint: 12 weeks and 24 weeks (from baseline);Adherence to TB treatmentTimepoint: 12 weeks and 24 weeks;Cost-effectiveness of the interventionsTimepoint: 12 weeks;Change in plasma metabolomeTimepoint: 12 weeks (from baseline);Change in fat free body massTimepoint: 12 weeks (from baseline);Difference in time to sputum conversionTimepoint: 8 weeks and 24 weeks;Preparation of biorepositoryTimepoint: Baseline, 12 weeks and 24 weeks;Dietary assessmentTimepoint: Baseline, 12 weeks and 24 weeks;Acceptability of interventionsTimepoint: 12 weeks;TB treatment successTimepoint: 24 weeks;Change in muscle strength in three study armsTimepoint: 12 weeks and 24 weeks (from baseline);Change in body weight in three armsTimepoint: 12 weeks and 24 weeks (from baseline);Change in BMI in three armsTimepoint: 12 weeks and 24 weeks (from baseline)	—

Measure

Time frame

Proportion of change in cachexia in three armsTimepoint: 12 weeks and 24 weeks (from baseline);Change in quality of lifeTimepoint: 12 weeks and 24 weeks (from baseline);Adherence to TB treatmentTimepoint: 12 weeks and 24 weeks;Cost-effectiveness of the interventionsTimepoint: 12 weeks;Change in plasma metabolomeTimepoint: 12 weeks (from baseline);Change in fat free body massTimepoint: 12 weeks (from baseline);Difference in time to sputum conversionTimepoint: 8 weeks and 24 weeks;Preparation of biorepositoryTimepoint: Baseline, 12 weeks and 24 weeks;Dietary assessmentTimepoint: Baseline, 12 weeks and 24 weeks;Acceptability of interventionsTimepoint: 12 weeks;TB treatment successTimepoint: 24 weeks;Change in muscle strength in three study armsTimepoint: 12 weeks and 24 weeks (from baseline);Change in body weight in three armsTimepoint: 12 weeks and 24 weeks (from baseline);Change in BMI in three armsTimepoint: 12 weeks and 24 weeks (from baseline)

—

Countries

India

Contacts

Public ContactDr Rashmi Rodrigues

St Johns Medical College Hospital, Bengaluru

rashmi.r@stjohns.in9845389538

Outcome results

None listed

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