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CTRI Number  CTRI/2020/05/025374 [Registered on: 27/05/2020] Trial Registered Prospectively
Last Modified On: 20/02/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   A Clinical Study to evaluate the safety and efficacy of Serracor-NK® and Serra Rx260 capsule in patients with idiopathic pulmonary fibrosis 
Scientific Title of Study   A Prospective, Interventional, Double-blind, Randomized, Placebo-Controlled Parallel Group Clinical Study to evaluate the safety and efficacy of Serracor-NK® and Serra Rx260 on improving symptoms and quality of life in patients with idiopathic pulmonary fibrosis 
Trial Acronym  ICBio/CR/AETL/0104/105 
Secondary IDs if Any
Modification(s)  
Secondary ID  Identifier 
ICBio/CR/AETL/0104/105 version 02 dated 03 Aug 2020  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)  
Name  Dr Vijaykumar Barge 
Designation  MD medicine 
Affiliation  Rajarshee Chhatrapati Shahu Maharaj Government Medical College  
Address  CPR Hospital Campus, Town Hall, Bhausingji Road Kolhapur

Kolhapur
MAHARASHTRA
416012
India 
Phone  9011066766  
Fax    
Email  rcsmgmc.research@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Harish S 
Designation  Director Operations 
Affiliation  ICBio Clinical Research Pvt Ltd 
Address  # 16 & 18,ICBio Tower Chikkabetahalli Yelahanka Main Road Vidyaranyapura

Bangalore
KARNATAKA
560097
India 
Phone  9900111997  
Fax    
Email  harish@icbiocro.com  
 
Details of Contact Person
Public Query  
Name  Dr Harish S 
Designation  Director Operations 
Affiliation  ICBio Clinical Research Pvt Ltd 
Address  # 16 & 18,ICBio Tower Chikkabetahalli Yelahanka Main Road Vidyaranyapura

Bangalore
KARNATAKA
560097
India 
Phone  9900111997  
Fax    
Email  harish@icbiocro.com  
 
Source of Monetary or Material Support  
Advanced Enzyme Technologies Ltd 
 
Primary Sponsor  
Name  Advanced Enzyme Technologies Ltd 
Address  A 135 Road No. 23 Wagle Industrial estate Thane W 400 604 India  
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL   
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 10  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Basavaraj Sangolli  Basaveshwara Medical College and Hospital   Chitradurga, .
Chitradurga
KARNATAKA 		 9538229646

fredy@syncretic.in 
Dr Ashish Jain  Chest Care Clinic  Ground Floor, Chest Care Clinic, 44 New Taj Market,Bhopal
Bhopal
MADHYA PRADESH 		 9424395291

chestcareclinicbhopal@gmail.com 
Dr Vilas Panchabhai  Gillurkar Multispeciality Hospital  20, Reshimbag, Umred road, Nagpur – 440009
Nagpur
MAHARASHTRA 		 9765411766

drvilaspanchabhai@yahoo.com 
Dr Ankush Garg   INDOGULF DIAGNOSTICS AND RESEARCH CENTRE PRIVATE LTD,  B-498, A, B Indogulf Diagnostics and Research Centre, Sector 19 Noida, UP -201301
South
DELHI 		 9650725225

drankush_1987@yahoo.com 
Dr Manish Agarwal  Medilink hospital and research center   17and 18 Jainam Bungalow Opp bileshwer Mahadev Satellite Ahmedabad
Ahmadabad
GUJARAT 		 9825443397

medilinkhospital@yahoo.com 
Dr Nihar Patel  Neha Medical and Heart Center  Room no. 03 S.T. workshop road, Mehsana – 384002
Mahesana
GUJARAT 		 9033556038

nihar103@gmail.com 
Dr Vijaykumar Barge  RCSMGMCIEC2 CPR Hospital  Rajarshee Chhatrapati Shahu Maharaj Government Medical College and Chhatrapati Pramila Raje General Hospital CPR Hospital Campus, Town Hall, Bhausingji Road Kolhapur, Maharashtra, India
Kolhapur
MAHARASHTRA 		 9011066766

rcsmgmc.research@gmail.com 
Dr Rajesh Godara   Rukmani Birla Hospital, A Unit of Calcutta Medical Research Institute  OPD, Ground Floor Near Triveni Flyover Gopal Pura Road Gopalpura,
Jaipur
RAJASTHAN 		 9686048921

Rakesh_godara@hotmail.com 
Dr Prashant Deshmukh   Sai hospital pune   Near Hanuman Mandir, Gangal chamber ,Main Road Akurdi,
Pune
MAHARASHTRA 		 7709307004

Ncwanshi@gmail.com 
Dr Himanshu Pophale  Shreeyash Hospital  Deccan, Pune, Maharashtra
Pune
MAHARASHTRA 		 7588693308

himanshupophale@yahoo.co.in 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 12  
Name of Committee  Approval Status 
Ethics committee of Ishwar institute of health carer   Approved 
Institutional Ethics committee Charak Hospital and research center   Approved 
Basaveshwara Medical College and Hospital Institutional Ethics Review committee   Approved 
Gillurkar Hospital Ethics Committee  Approved 
Indogulf Institutional Ethics committee  Approved 
Institutional EC Sai sneh Hospital and Diagnostic centar  Approved 
Institutional Ethics Committee Rukmani Birla Hospital  Approved 
Medilink ethics committee   Approved 
Rajalakshmi Hospital instituational ethics committee  Approved 
RCSMGMCIEC2  Approved 
ROYAL PUNE INDEPENDEPENT ETHICS COMMITTEE  Approved 
Shreenidhi heart and medical hospital Ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J841||Other interstitial pulmonary diseases with fibrosis,  
 
Intervention / Comparator Agent
Modification(s)  
Type  Name  Details 
Comparator Agent  Placebo and Placebo  3 times a day (Ensure a gap of 5-6 hours between supplement intake)for 176 days mentioned in the dosing chart 
Intervention  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 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  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.
 
 
ExclusionCriteria 
Details  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

 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Other 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
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 “Symptom” 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)
 		 From day 1 to day 176 
 
Secondary Outcome  
Outcome  TimePoints 
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
3 Safety of IP as assessed from the lab parameter
a AST, ALT and Total Bilirubin
b Physical examination 		 From day 1 to day 176 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="100" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   01/06/2020 
Date of Study Completion (India) 14/07/2022 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   A Prospective, Interventional, Double-blind, Randomized, Placebo-Controlled Parallel Group Clinical Study to evaluate the safety and efficacy of Serracor-NK® and Serra Rx260 on improving symptoms and quality of life in patients with idiopathic pulmonary fibrosis.
Duration of the study for the subject will be 176 days (Approximately 6 month)

Total of  100  subjects will be enrolled in the study.

  1. Test (n=50 randomized)
  2. Placebo (n=50 randomized





 
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