Health Condition 1: J841- Other interstitial pulmonary diseases with fibrosis
Conditions
Interventions
Intervention1: Serracor-NK® and Serra Rx260: 3 times a day (Ensure a gap of 5-6 hours between supplement intake)for 176 days mentioned in the dosing chart
Control Intervention1: Placebo and Placebo:
Sponsors
Advanced Enzyme Technologies Ltd
Eligibility
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. To evaluate the effects of Serracor-NK® and Serra Rx260 on pulmonary fibrosis symptoms using UCSD shortness-of-breath (UCSD-SOB) questionnaire 2 Symptoms of IPF, as assessed by change in score for â??Symptomâ?? domain of St. George Respiratory Questionnaire 3 To assess the quality of life of patients as perceived by overall wellbeing and mental wellbeing in patients with IPF using a)UCSD-SOB b)SGRQ c)WHO (Five) Well-Being Index (WHO-WBI) Timepoint: From day 1 to day 176 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To evaluate the effect of Serracor-NK® and Serra Rx260 as assessed by rate of decline in â??Forced Vital Capacity (FVC)â?? in spirometry 2 Monitoring of AE and SAE 3 Safety of IP as assessed from the lab parameter a AST, ALT and Total Bilirubin b Physical examinationTimepoint: From day 1 to day 176 | — |
Countries
India
Contacts
Public ContactDr Harish S
ICBio Clinical Research Pvt Ltd
Outcome results
None listed