Study of the value of drug tadalafil on improvement in effort tolerance in patients of chronic lung diseases.

â??To study the effect of tadalafil on exercise capacity and cardiopulmonary haemodynamics in chronic pulmonary disease patients with pulmonary arterial hypertension: A hospital based prospective randomized controlled trialâ??.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2015/01/005413

Enrollment

100

Registered

2015-01-15

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: null- Chronic pulmonary disease patients with pulmonary arterial hypertension (PAH).

Interventions

Intervention1: Tadalafil 40 mg once a day.: Intervention group was taking tadalafil 40 mg once a day with baseline medications

Deriphylline 300mg OD, Formoterol fumarate 200mcg + Budesonide 6mcg OD, Tiotropium bromide monohydrate 18mcg OD, Tiotropium bromide 9mcg + formoterol fumarate dehydrate 6mcg OD, Fluticasone propionate

Eligibility

Inclusion criteria

Inclusion criteria: 1. Adult males or females with a diagnosis of chronic pulmonary disease with PAH. 2. Patients between 20 to 80 years of age. 3. Willingness to participate in the study.

Exclusion criteria

Exclusion criteria: 1. History or clinical evidence of chronic pulmonary diseases without PAH. 2. Patients of Coronary artery disease, chronic kidney disease, liver disease, Left ventricular failure. 3. Patients with myopathy/muscular dystrophy 4. Patients with Peripheral vascular disease/Osteoarthritis of Knees 5. Pregnancy 6. Patients aged less than 20 years and more than 80 years 7. Drug history of Anorexigens 8. Patients with HIV 9. Patient unwilling to participate in the study

Design outcomes

Primary

Measure	Time frame
â?¢ To study the effect of tadalafil on 6-minute walk distance in chronic pulmonary disease patients with pulmonary arterial hypertension.Timepoint: primary outcome parameters was reassessed after three months	—

Secondary

Measure	Time frame
â?¢ To study the effect of tadalafil on; o RV Function, PVR, PAH and arterial blood gases. o Association of 6-minute walk distance with indices of cardio- pulmonary haemodynamics, pulmonary function and arterial oxygen saturation. o Quality of Life. Timepoint: Reassessment of variable cardiopulmonary haemodynamic parameters and quality of life was done after three months.	—

Countries

India

Contacts

Public ContactDr Ashok Kumar Sahai

Indira Gandhi Medical College, Shimla, Himachal Pradesh, India.

drashoksahai@gmail.com94184-68582

Outcome results

None listed

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