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: Other interstitial pulmonary diseases with fibrosis,

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

Brief Summary

AProspective, Interventional, Double-blind, Randomized, Placebo-ControlledParallel Group Clinical Study to evaluate the safety and efficacy ofSerracor-NK® and Serra Rx260 on improving symptoms andquality of life in patients with idiopathic pulmonary fibrosis.

Durationof the study for the subject will be 176 days (Approximately 6 month)

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|Total of  100  subjects will be enrolled in the study.

1. Test (n=50 randomized)

2. Placebo (n=50 randomized

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-06
• Study Completion: 2022-07-14
• Last Update Posted: 2023-02-20

Recruitment & Eligibility

• Status: Completed
• Sex: All
• 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.

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 patient’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

Primary Outcome Measures

Name	Time	Method
1. To evaluate the effects of Serracor-NK® and Serra Rx260 on pulmonary fibrosis symptoms using UCSD shortness-of-breath (UCSD-SOB) questionnaire	From day 1 to day 176
3 To assess the quality of life of patients as perceived by overall wellbeing and mental wellbeing in patients with IPF using	From day 1 to day 176
a)UCSD-SOB	From day 1 to day 176
b)SGRQ	From day 1 to day 176
c)WHO (Five) Well-Being Index (WHO-WBI)	From day 1 to day 176
2 Symptoms of IPF, as assessed by change in score for “Symptom†domain of St. George Respiratory Questionnaire	From day 1 to day 176

Secondary Outcome Measures

Name	Time	Method
1. To evaluate the effect of Serracor-NK® and Serra Rx260 as assessed by rate of decline in “Forced Vital Capacity (FVC)†in spirometry	2 Monitoring of AE and SAE

Trial Locations

Locations (10)

Basaveshwara Medical College and Hospital; 🇮🇳 Chitradurga, KARNATAKA, India

Chest Care Clinic; 🇮🇳 Bhopal, MADHYA PRADESH, India

Gillurkar Multispeciality Hospital; 🇮🇳 Nagpur, MAHARASHTRA, India

INDOGULF DIAGNOSTICS AND RESEARCH CENTRE PRIVATE LTD,; 🇮🇳 South, DELHI, India

Medilink hospital and research center; 🇮🇳 Ahmadabad, GUJARAT, India

Neha Medical and Heart Center; 🇮🇳 Mahesana, GUJARAT, India

RCSMGMCIEC2 CPR Hospital; 🇮🇳 Kolhapur, MAHARASHTRA, India

Rukmani Birla Hospital, A Unit of Calcutta Medical Research Institute; 🇮🇳 Jaipur, RAJASTHAN, India

Sai hospital pune; 🇮🇳 Pune, MAHARASHTRA, India

Shreeyash Hospital; 🇮🇳 Pune, MAHARASHTRA, India

Basaveshwara Medical College and Hospital

🇮🇳Chitradurga, KARNATAKA, India

Dr Basavaraj Sangolli

Principal investigator

9538229646

fredy@syncretic.in