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CTRI Number  CTRI/2026/01/101022 [Registered on: 14/01/2026] Trial Registered Prospectively
Last Modified On: 05/01/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Dietary protocol]  
Study Design  Single Arm Study 
Public Title of Study   Effect of a millet-based diet in quality of life in cancer patients 
Scientific Title of Study   Impact of a Low-Grain therapeutic diet on nutritional status, symptoms and quality of life in cancer patients: A Quasi-experimental study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Pradeep M K Nair 
Designation  Medical Director & Chief Scientist 
Affiliation  Mirakle Integrated Health Centre 
Address  Department of Integrative Oncology, Room No:1, Mirakle Integrated Health Centre, NPTC-MCET Campus, Udumalai Road, Pollachi

Coimbatore
TAMIL NADU
642003
India 
Phone    
Fax    
Email  research@mirakleihc.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Pradeep M K Nair 
Designation  Medical Director & Chief Scientist 
Affiliation  Mirakle Integrated Health Centre 
Address  Department of Integrative Oncology, Room No: 1, Mirakle Integrated Health Centre, NPTC-MCET Campus, Udumalai Road, Pollachi

Coimbatore
TAMIL NADU
642003
India 
Phone    
Fax    
Email  research@mirakleihc.com  
 
Details of Contact Person
Public Query  
Name  Dr Pradeep M K Nair 
Designation  Medical Director & Chief Scientist 
Affiliation  Mirakle Integrated Health Centre 
Address  Department of Integrative Oncology, Room No:1, Mirakle Integrated Health Centre, NPTC-MCET Campus, Udumalai Road, Pollachi

Coimbatore
TAMIL NADU
642003
India 
Phone    
Fax    
Email  research@mirakleihc.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Mirakle Integrated Health Centre  
Address  NPT-MCET Campu, Udumalai road, Pollachi, Tamil Nadu, India. Pincode: 642003 
Type of Sponsor  Private hospital/clinic 
 
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 Pradeep MK Nair  Mirakle Integrated Health Centre  Department of Integrative Oncology, Room No: 1, NPT-MCET Campus, Udumalai road, Pollachi - 642003.
Coimbatore
TAMIL NADU 		 8667483682

research@mirakleihc.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Mirakle Integrated Health Centre  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C00-D49||Neoplasms,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Low grain diet   Cancer patients are put under low grain diet for at least 24 or more. On discharge a diet chart will be provided to follow for 3 months until next assessment 
Comparator Agent  NA  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Cancer patients who are aged between 18 to 80 years and oral food intake is possible. Patients who are willing and able to give informed consent 
 
ExclusionCriteria 
Details  Cancer patients who are below 18 years of and oral intake is not possible. Patient who are on nasogastric tube feeding or surgery involving GI tract, like gastrectomy etc. Also patient who are unable to give consent in due to mental illness are excluded 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
PG-SGA total score  Baseline (at the start of treatment)
After 24 days of treatment
After 3 months
 
 
Secondary Outcome  
Outcome  TimePoints 
Anthropometric assessments
Biochemical parameters (LFT, Total protein, Hb, HbA1c, Vitamin D, Vitamin B12, LDH & Ferritin )
Edmonton Symptom Assessment Scale
Chuangs prognosis scale 		 Baseline, after 24 days treatment & after 3 months follow up 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   16/01/2026 
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   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   Cancer and its treatment often lead to poor nutrition, weight loss, and reduced quality of life in patients. Proper dietary support may help improve nutritional status and overall well being. Millets are nutrient rich, low glycemic grains that can be used as part of a supportive diet for cancer patients. The Mirakle low grain diet protocol is designed to meet the nutritional needs of cancer patients and is easy to digest and culturally acceptable. This study aims to evaluate the effect of a structured one month low grain diet protocol on nutritional status and quality of life in hospitalized cancer patients and to assess whether these benefits are sustained at three months after discharge. The hypothesis of the study is that the low grain diet protocol will improve nutritional status and quality of life in cancer patients, with sustained benefits observed at follow up. 
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