A study to assess whether the use of atorvastatin for six months can improve lung function in people who have suffered from lung damage due to tuberculosis.

Efficacy of six-month daily atorvastatin therapy on lung function in Post-tubercular lung disease: A double-blind parallel arm randomized control trial. - NIL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/04/084690

Enrollment

120

Registered

2025-04-13

Start date

Unknown

Completion date

Unknown

Last updated

2025-04-28

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

Conditions

Health Condition 1: B909- Sequelae of respiratory and unspecified tuberculosis

Interventions

Intervention1: Atorvastatin: Tablet atorvastatin 40 mg will be given to patient daily for six months. Control Intervention1: Placebo: Tablet placebo 40 mg will be given to patient daily for six months

Eligibility

Inclusion criteria

Inclusion criteria: Patients having history of pulmonary TB who have been declared cure or treatment completed. Plus, Patients experiencing chronic respiratory symptoms like dyspnoea, cough and expectoration and/or radiologically evident abnormality such as fibrocavitary disease, or bronchiectasis.

Exclusion criteria

Exclusion criteria: 1. Lack of informed consent. 2. Patients who have concurrent diseases like asthma, COPD, sarcoidosis, interstitial lung diseases, and connective tissue disorders. 3. Patients who are already on statins as lipid-lowering agents or who have dyslipidaemia. 4. History of hypersensitivity reaction to atorvastatin 5. Active liver disease, previous history of liver disease, unexplained transaminitis. 6. Previous history of myopathies or active myopathies. 7. Previous or concurrent history of coronary artery disease. 8. Former or active smoker. 9. Patients with renal impairment. 10. Pregnancy. 11. Patients taking drugs like amiodarone, azole antifungals, cyclosporine, and macrolide antibiotics.

Design outcomes

Primary

Measure	Time frame
Change in spirometric variables forced expiratory volume at one second (FEV1) and forced vital capacity (FVC) at six months.Timepoint: 0 and 6 months	—

Secondary

Measure	Time frame
Change in six-minute walk distance at six months.Timepoint: 0 and 6 month;Change in SGRQ at six months.Timepoint: 0 and 6 month;Change in serum TGF beta1, MMP1, MMP3, MMP9, MMP12 and TIMP1 levels at six months.Timepoint: 0 and 6 month;Treatment related adverse drug reactions.Timepoint: 6 months	—

Countries

India

Contacts

Public ContactAnanda Datta

All India Institute of Medical Sciences, Deoghar

19.ananda.88@gmail.com8290362681

Outcome results

None listed

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