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CTRI Number  CTRI/2022/03/040915 [Registered on: 08/03/2022] Trial Registered Prospectively
Last Modified On: 07/03/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Fermented rice water]  
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Effect of traditional fermented rice-water supplementation to pregnant women 
Scientific Title of Study   Impact of traditional fermented rice-water on maternal nutrition in Odisha, India 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NA  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Balamurugan Ramadass 
Designation  Additional Professor 
Affiliation  All India Institutes for Medical Sciences Bhubaneswar 
Address  Room No 149, 1st floor, Department of Biochemistry, Academic Building, AIIMS-BBSR Sijua, Patarapada, Bhubaneswar

Khordha
ORISSA
751019
India 
Phone  9438884251  
Fax    
Email  balaramadass1@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Balamurugan Ramadass 
Designation  Additional Professor 
Affiliation  All India Institutes for Medical Sciences Bhubaneswar 
Address  Room No 149, 1st floor, Department of Biochemistry, Academic Building, AIIMS-BBSR Sijua, Patarapada, Bhubaneswar


ORISSA
751019
India 
Phone  9438884251  
Fax    
Email  balaramadass1@gmail.com  
 
Details of Contact Person
Public Query  
Name  Balamurugan Ramadass 
Designation  Additional Professor 
Affiliation  All India Institutes for Medical Sciences Bhubaneswar 
Address  Room No 149, 1st floor, Department of Biochemistry, Academic Building, AIIMS-BBSR Sijua, Patarapada, Bhubaneswar


ORISSA
751019
India 
Phone  9438884251  
Fax    
Email  balaramadass1@gmail.com  
 
Source of Monetary or Material Support  
Bill & Melinda Gates Foundation (BMGF) 
 
Primary Sponsor  
Name  Bill Melinda Gates Foundation 
Address  Bill & Melinda Gates Foundation Delhi, India 
Type of Sponsor  Other [Global research] 
 
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 Balamurugan Ramadass  All India Institute of Medical sciences Bhubaneswar  Room No. 149, Academic Block, AIIMS-BBSR
Khordha
ORISSA 		 8547805341

balaramadass1@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
AIIMS Bhubaneswar Ethical committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  adult reproductive age women  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Fermented rice water  500ml per day for 4 months 
Comparator Agent  Ready mix rice water  500ml per day for 4 months 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  25.00 Year(s)
Gender  Female 
Details  1. Non-pregnant participants: women aged >18 years, staying in the locality and expected to stay for next 6-8 months; access to the phone for contact; not suffering from any major systemic disease, ambulatory
2. Pregnant participants: pregnant women aged >18 years, first trimester pregnancy, no high risk factors or bad obstetric history, staying in the locality and expected to stay for next 6-8 months; access to phone for contact; not suffering from any major systemic disease, ambulatory
 
 
ExclusionCriteria 
Details  1. Refusal for consent, inability to follow the schedule, unwilling to accept or not feasible to consume the fermented rice-water as per schedule 
 
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 
Documentation of the impact of the fermented-rice (Torani) intake on nutrition, gut and vaginal microbiota, gut microbiome, and inflammatory markers in reproductive-age women  0, 1, 2, 4, and 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
To document effect of the fermented-rice (Torani) intake on inflammatory markers in reproductive-age women  0, 1, 2, 4, and 6 months 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
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)   14/03/2022 
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="1"
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  

We propose to document the effect of traditional fermented rice-water (Pakhala/Torani) on gut and vaginal microbiome, nutritional profile, and inflammatory markers in reproductive age women in Odisha (India) as an effort to address the maternal nutritional problem. The Torani is expected to have multidimensional effects including nutrition (micro-/macro-nutrients), gut microbiome, gut and systemic inflammation, and source of short-chain fatty acids (SCFAs) for energy. To explore the characterization of the microbiota, SCFAs, nutrients, and volatile compounds in Torani samples prepared using different rice types over varying fermentation periods and the effect on gut microbiota and nutrition and inflammatory markers in healthy adults for documenting dose effect. 

 
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