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CTRI Number  CTRI/2023/11/060102 [Registered on: 21/11/2023] Trial Registered Prospectively
Last Modified On: 28/08/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical
Other (Specify) [Millet based food supplementation and nutrition education]  
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Role of millets in controlling diseases 
Scientific Title of Study   Efficacy of Millet Based Nutrition Interventions in the Management of Lifestyle Disorders (Obesity, Diabetes and Dyslipidemia) 
Trial Acronym  NIM (Nutrition Impact of Millets) 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DrTarvinder Jeet Kaur 
Designation  Professor and Supervisor 
Affiliation  Kurukshetra University 
Address  Room no.115, First floor, Department of Home Science, Kurukshetra University, Kurukshetra

Kurukshetra
HARYANA
136119
India 
Phone  9992027023  
Fax    
Email  tarvin_khushi@rediffmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Samridhi Sharma 
Designation  Research Scholar 
Affiliation  Kurukshetra University 
Address  Research lab, first floor, Department of Home Science, Kurukshetra University, Kurukshetra

Kurukshetra
HARYANA
136119
India 
Phone  7206318581  
Fax    
Email  samridhi.235@kuk.ac.in  
 
Details of Contact Person
Public Query
 
Name  Samridhi Sharma 
Designation  Research Scholar 
Affiliation  Kurukshetra University 
Address  Research lab, first floor, Department of Home Science, Kurukshetra University, Kurukshetra

Kurukshetra
HARYANA
136119
India 
Phone  7206318581  
Fax    
Email  samridhi.235@kuk.ac.in  
 
Source of Monetary or Material Support  
Lok Nayak Jay Prakash Hospital, Kurukshetra-136119 
 
Primary Sponsor  
Name  Samridhi Sharma 
Address  Department of Home Science, Kurukshetra University, Kurukshetra 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
Dr Tarvinder Jeet Kaur  Department of Home Science, Kurukshetra University, Kurukshetra 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DrGurpreet Singh  Lok Nayak Jay Prakash Hospital  Room No.414, LNJP Hospital, Bye pass road, Darra Khera, Kalyan Nagar, Thanesar, Haryana-136118
Kurukshetra
HARYANA 
9812921012

drgpsinghlnjp@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
INSTITUTIONAL HUMAN ETHICS COMMITTEE (IHEC) OF KURUKSHETRA UNIVERSITY KURUKSHETRA  Approved 
LOK NAYAK JAY PRAKASH HOSPITAL  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E669||Obesity, unspecified, (2) ICD-10 Condition: R798||Other specified abnormal findingsof blood chemistry, (3) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
Intervention  Nutrition education and millet supplementation  Audio visual aids, dietary counseling, millet supplementation  
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Obese, diabetic and dyslipidemic subjects in the age of 20-60 years, males and females, non-dependent on statins and not suffering from any diabetes related complications like ketoacidosis, diabetic nephropathy, etc. 
 
ExclusionCriteria 
Details  Patients suffering from renal disorders, cancer, HIV-AIDS, respiratory disorders, pneumonia, thyroid disorders, high uric acid level, tuberculosis are excluded 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To study the impact of millet based nutrition interventions  2 Years 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate anthropometric, biochemical, clinical, and dietary status of subjects  2 years 
 
Target Sample Size   Total Sample Size="180"
Sample Size from India="180" 
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   Phase 2 
Date of First Enrollment (India)   01/12/2023 
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="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
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 study the efficacy of millet based nutrition interventions on the nutritional status of people with obesity, diabetes and dyslipidemia. The impact of millet supplementation and nutrition education on nutritional status of subjects will be assessed. The data pertaining to the nutritional status of the subjects will be collected 3 times, i.e.; before the commencement of intervention (0 days), in the middle of intervention (90 days) and at the end of intervention (180 days). 

 
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