A Clinical Study to evaluate the safety and efficacy of Serracor-NK® and Serra Rx260 capsule in patients with idiopathic pulmonary fibrosis

Phase 3

Completed

• Conditions: Health Condition 1: J841- Other interstitial pulmonary diseases with fibrosis

• Registration Number: CTRI/2020/05/025374
• Lead Sponsor: Advanced Enzyme Technologies Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2022-07-14
• Last Update Posted: 6 March 2023

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 100

Inclusion Criteria

1 Clinical diagnosis of Idiopathic pulmonary fibrosis (IPF) within the last 3 years from screening based upon the American Thoracic Society/ European Respiratory Society Consensus Statement.

2 Male or female patients aged more than 18 years at screening.

3 Forced vital capacity (FVC) more than 50% of predicted normal.

4 Given written informed consent to participate in the study.

Exclusion Criteria

1 Patients with HRCT Pattern of Probable / Indeterminate for UIP

2 Patients currently on Extracorporeal Membrane Oxygenation

3 Patients with acute IPF exacerbation or any respiratory tract infection within the four weeks prior to the screening period;

4 Alanine transaminase (ALT), Aspartate aminotransferase (AST) more than 1.5-fold upper limit of normal (ULN)

5 Total bilirubin more than 1.5-fold ULN

6 Relevant airways obstruction pre-bronchodilator Forced expiratory volume in 1 second / Forced vital capacity less than 0.70

7 History of Acute Coronary Syndrome

8 Subjects on herbal or mineral preparations for the treatment of IPF.

9 Pneumonia diagnoses by High-resolution computed tomography (HRCT) will be performed at the time of screening.

10 Planned major surgery during the trial participation, including lung transplantation, major abdominal or major intestinal surgery;

11 A disease or condition which in the opinion of the investigator may interfere with testing procedures or put the patient at risk when participating in this trial;

12 Alcohol or drug abuse which in the opinion of the treating physician would interfere with the treatment and would affect patientâ??s ability to participate in this trial;

13 Patients not able to understand and follow any study procedures such as but not limited to home spirometry, including completion of self-administered questionnaires without help;

14 Women who are pregnant, nursing, who plan to become pregnant while in the trial;

15 Women of childbearing potential not willing or able to use highly effective methods of birth control.

16 Patients who are or have been participating in another trial with investigational drugs within one month prior to screening

Study & Design

• Study Type: Interventional
• Study Design: Not specified