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The effect of deep lung support capsule in idiopathic pulmonary fibrosis

Investigating the effectiveness and side effects of Deep Lung Support capsule as adjuvant treatment with prefenidone compared to placebo on clinical symptoms, pulmonary function tests and serum TGF-ß levels in patients with idiopathic pulmonary fibrosis.

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20230509058135N1
Enrollment
70
Registered
2023-05-22
Start date
2023-05-10
Completion date
Unknown
Last updated
2023-05-29

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

Conditions

Idiopathic Pulmonary Fibrosis. Idiopathic pulmonary fibrosis

Interventions

Intervention 1: Intervention group: In addition to pirfenidone tablets, each subject in the intervention group will take an oral deep lung support capsule three times a day with water. The way to take

Sponsors

Shahid Beheshti University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 80 Years

Inclusion criteria

Inclusion criteria: Forced vital capacity (FVC) greater than 40% and less than or equal to 90% Diffusing capacity of the lungs for carbon monoxide (DLCO) greater than or equal to 40% and less than or equal to 90%

Exclusion criteria

Exclusion criteria: Having an FEV1/FVC ratio of less than 0.8 (after bronchodilator administration) at screening Suffering from other interstitial lung diseases, history of asthma or chronic lung disease, active infection, being treated with other IPF treatment methods such as immunosuppressives and cytokine regulating agents. History of unstable or worsening heart or lung disease (except IPF) in the past six months Pregnant and lactating women

Design outcomes

Primary

MeasureTime frame
Clinical symptoms (cough and shortness of breath). Timepoint: Once before starting treatment and once 3 months after that. Method of measurement: "Rate of perceived exertion" and "cough symptom score" scales.;Pulmonary function tests. Timepoint: Once before starting treatment and once 3 months after that. Method of measurement: by spirometry.;TGF-ß serum level. Timepoint: Once before starting treatment and once 3 months after that. Method of measurement: by blood sample testing.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSasan Tavana

Shahid Beheshti University of Medical Sciences

sasan.tavana@yahoo.com+98 21 23871

Outcome results

None listed

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