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CTRI Number  CTRI/2024/10/074891 [Registered on: 08/10/2024] Trial Registered Prospectively
Last Modified On: 04/05/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Use of oral lactoferrin ( extracted from milk ) in ulcerative colitis. 
Scientific Title of Study   Role of Oral Lactoferrin in the treatment of Mild to Moderate Ulcerative Colitis - A Pilot Randomized controlled trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dawesh Prakash Yadav 
Designation  Associate professor and head , dept of Gastroenterology, IMS BHU 
Affiliation  IMS BHU, Varanasi 
Address  Head of dept , dept of gastroenterology , Sir sunderlalal hospital , IMS BHU

Varanasi
UTTAR PRADESH
221005
India 
Phone  8130856563  
Fax    
Email  devesh.thedoc@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dawesh Prakash Yadav 
Designation  Associate professor and head , dept of Gastroenterology, IMS BHU 
Affiliation  IMS BHU, Varanasi 
Address  Head of dept , dept of gastroenterology , Sir sunderlalal hospital , IMS BHU

Varanasi
UTTAR PRADESH
221005
India 
Phone  8130856563  
Fax    
Email  devesh.thedoc@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dawesh Prakash Yadav 
Designation  Associate professor and head , dept of Gastroenterology, IMS BHU 
Affiliation  IMS BHU, Varanasi 
Address  Head of dept , dept of gastroenterology , Sir sunderlalal hospital , IMS BHU

Varanasi
UTTAR PRADESH
221005
India 
Phone  8130856563  
Fax    
Email  devesh.thedoc@gmail.com  
 
Source of Monetary or Material Support  
Institute of Medical Sciences ,BHU, Varanasi , U.P. , INDIA , Pin - 221005 
 
Primary Sponsor  
Name  IMS BHU 
Address  Sir Sunderlal hospital, IMS BHU, Varanasi , U.P. , INDIA, Pin - 221005 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DR AJAY  Institute of Medical Sciences , BHU  Dept of Gastroenterology, 2nd floor , New SSB, Sir sunderlal hospital, IMS BHU
Varanasi
UTTAR PRADESH 		 8866836790

ajaysingla011@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC, IMS BHU  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K519||Ulcerative colitis, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Oral lactoferrin   Oral lactoferrin will be given to mild to moderate UC patients in doses of 1 gm /day in addition to standard medical therapy for 3 months and response will be analysed and compared with comparator group . 
Comparator Agent  placebo   second group will be given standard medical therapy with placebo for the period of 3 months 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  all patients in above age group with mild to moderate ulcerative colitis defined by complete mayo score 3-10 and UCEIS score greater than 1 will be included in the study  
 
ExclusionCriteria 
Details  patients requiring hospitalization or colectomy, patients having history of surgery for ulcerative colitis, patients having concomitant GI infections and patients who are not giving consent for the study are to be excluded  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
difference in treatment response in 2 groups, which is defined by decrease in complete mayo score by 3 points  At baseline & 3 months 
 
Secondary Outcome  
Outcome  TimePoints 
difference in the mean change in levels of biochemical variables such as hemoglobin , CRP levels & fecal calprotectin levels  At baseline & 3 months time 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/10/2024 
Date of Study Completion (India) 23/03/2026 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)   Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [ajaysingla011@gmail.com].

  6. For how long will this data be available start date provided 02-03-2026 and end date provided 03-02-2031?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary
Modification(s)  		 it is a pilot , placebo controlled , double blind , randomized controlled trial to be conducted in the  department of gastroenterology at IMS BHU, Varanasi. The purpose  of the study is to determine the role of oral lactoferrin in the treatment of mild to moderate ulcerative colitis. The study is approved by the institutional ethics committee at IMS BHU.  Patients ,aged 18-60 years ,having mild to moderate ulcerative colitis and presenting to gastroenterology OPD , will be enrolled in the study  after applying inclusion and exclusion criteria and  taking written and informed consent of the patient and will be randomized into 2 groups - oral lactoferrin plus standard medical therapy versus standard medical therapy alone and group A will be given oral  lactoferrin in doses of 1 gm/day along with standard medical therapy while group B will be given placebo along with standard medical therapy . both group patient will be followed up for study duration of 3 months and at the end of 3 months, treatment response will be assessed using complete mayo score .  
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