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CTRI Number  CTRI/2022/03/041000 [Registered on: 11/03/2022] Trial Registered Prospectively
Last Modified On: 10/03/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Effects of Fermented rice water supplementation to Health care workers providing COVID Care 
Scientific Title of Study   Impact of Traditional Fermented Rice Water on Health Care Workers working in COVID-19 Unit 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NA  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Mahalingam Venkateshan 
Designation  Assistant Professor 
Affiliation  All India Institutes for Medical Sciences Bhubaneswar 
Address  Room Number 108, First Floor, College of Nursing, AIIMS-BBSR, Sijua, Patrapada, Bhubaneswar, Odisha

Khordha
ORISSA
751019
India 
Phone  9719874259  
Fax    
Email  nurs_mahalingam@aiimsbhubaneswar.edu.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Mahalingam Venkateshan 
Designation  Assistant Professor 
Affiliation  All India Institutes for Medical Sciences Bhubaneswar 
Address  Room Number 108, First Floor, College of Nursing, AIIMS-BBSR, Sijua, Patrapada, Bhubaneswar, Odisha

Khordha
ORISSA
751019
India 
Phone  9719874259  
Fax    
Email  nurs_mahalingam@aiimsbhubaneswar.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr Mahalingam Venkateshan 
Designation  Assistant Professor 
Affiliation  All India Institutes for Medical Sciences Bhubaneswar 
Address  Room Number 108, First Floor, College of Nursing, AIIMS-BBSR, Sijua, Patrapada, Bhubaneswar, Odisha

Khordha
ORISSA
751019
India 
Phone  9719874259  
Fax    
Email  nurs_mahalingam@aiimsbhubaneswar.edu.in  
 
Source of Monetary or Material Support  
Material Support-CCMR, AIIMS Bhubaneswar 
Monetary Support-AIIMS Bhubaneswar Intramural grant 
 
Primary Sponsor  
Name  The Director AIIMS Bhuabneswar 
Address  Director office, Academic Building, Sijua, Patrapada, Bhubaneswar, Odisha 751019 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NA  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 Mahalingam Venkateshan  All India Institute of Medical sciences Bhubaneswar  Room Number 108, First Floor, College of Nursing, AIIMS-BBSR, Sijua, Patrapada, Bhubaneswar, Odisha
Khordha
ORISSA 		 9719874259

nurs_mahalingam@aiimsbhubaneswar.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
AIIMS Bhubaneswar Institutional ethical committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy healthcare workers who are posting in COVID19 wards 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Fermented rice water   500ml per day for 15 days  
Comparator Agent  Regular diet  Regular diet without any limitations 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Healthcare workers who are exposed to Covid positive cases for a minimum period of 15 days.
2. Willing to give consent.
 
 
ExclusionCriteria 
Details  1. Healthcare workers who are not exposed to COVID-19 unit or positive cases
2. Healthcare workers who are not willing to participate in the study
3. Antibiotic usage during the study period
4. History of COVID-19 infection in the past.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Impact of traditional food and their immune modulation (IL-6, IL-8 and TNF- α ) among healthcare workers will be documented  Day 0 and Day 16 
 
Secondary Outcome  
Outcome  TimePoints 
Microbiome signatures of the front line healthcare workers posted in COVID-19 Care with and without fermented rice water consumption will be documented and anti-viral peptides will be measured and   Day 0 and Day 16 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/04/2022 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

This study aims to understand the impact of fermented rice water on the nasal microbiome, inflammatory markers, and cytokines of healthcare workers and the quality of their life before and after consuming fermented rice water. There is no clear understanding of the influence of fermented rice water on the microbiome signatures of nasal swabs on the health workers who are posted in the COVID-19 unit. The fermented rice water is a rich source of specific bacteria known to exert beneficial functions in humans (lactobacillus) and micro-nutrients, minerals, and Short-Chain fatty Acid (SCFAs). We have identified this as the economically low cost and the best to improve the quality of life of health workers, which needs to be addressed.

 
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