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CTRI Number  CTRI/2025/03/081771 [Registered on: 06/03/2025] Trial Registered Prospectively
Last Modified On: 01/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [DIETARY SUPPLEMENT ]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Can Beetroot Juice Help Protect Kidney Health? A Study on Its Role in Preventing Kidney Injury in Patients with Chronic Kidney Disease Undergoing Angiogram in India 
Scientific Title of Study   A PROSPECTIVE STUDY ON THE EFFICACY OF BEETROOT JUICE IN PREVENTING CONTRAST-INDUCED NEPHROPATHY IN CKD PATIENTS UNDERGOING ANGIOGRAM/PCI IN THE INDIAN POPULATION 
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 RAJESH THACHATHODIYIL 
Designation  Head of Department ,Professor 
Affiliation  AMRITA INSTITUTE OF MEDICAL SCIENCES AND RESEARCH CENTRE 
Address  DEPARTMENT OF CARDIOLOGY, AIMS HOSPITAL, KOCHI, ERNAKULAM, INDIA.

Ernakulam
KERALA
682024
India 
Phone  7907308342  
Fax    
Email  drtrajesh@aims.amrita.edu  
 
Details of Contact Person
Scientific Query  
Name  DR RAJESH THACHATHODIYIL 
Designation  Head of Department ,Professor, Department of Cardiology, School of Medicine, Kochi 
Affiliation  AMRITA INSTITUTE OF MEDICAL SCIENCES AND RESEARCH CENTRE 
Address  DEPARTMENT OF CARDIOLOGY, AIMS HOSPITAL, KOCHI, ERNAKULAM, INDIA.

Ernakulam
KERALA
682024
India 
Phone  7907308342  
Fax    
Email  drtrajesh@aims.amrita.edu  
 
Details of Contact Person
Public Query  
Name  Sachin G Nair 
Designation  PharmD Intern 
Affiliation  AMRITA INSTITUTE OF MEDICAL SCIENCES AND RESEARCH CENTRE 
Address  DEPARTMENT OF PHARMACY PRACTICE, AIMS HOSPITAL, KOCHI, ERNAKULAM, KERELA, INDIA.

Ernakulam
KERALA
682024
India 
Phone  7907766199  
Fax    
Email  sachunairg1891@gmail.com  
 
Source of Monetary or Material Support  
Amrita Vishwavidyapeetham, Amrita Institute of Medical Sciences and Research Center, AIMS Hospital, Kochi, Ernakulam, Kerela, India. PIN CODE: 682024 
 
Primary Sponsor  
Name  AMRITA SCHOOL OF PHARMACY 
Address  AMRITA SCHOOL OF PHARMACY, AMRITA INSTITUTE OF MEDICAL SCIENCES AND RESEARCH CENTER, PONEKKARA PO, EDAPPALLY, KOCHI, ERNAKULAM, KERELA, INDIA. PIN CODE: 682024 
Type of Sponsor  Research institution and hospital 
 
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 Rajesh Thachathodiyil  Amrita Hospital  Department of Cardiology, Amrita Hospital, Kochi, Ernakulam, Kerela, India.
Ernakulam
KERALA 		 7907308342

drtrajesh@aims.amrita.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC AIMS  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I222||Subsequent non-ST elevation (NSTEMI) myocardial infarction,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  beetroot juice  concentrated beetroot juice without diluting with water and without adding sugar 
Comparator Agent  HYDRATION REGIMEN  Hydration therapy at 1-1.5ml/kg/hr for 3- 12hours before and 6-12hr after the procedure 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  1. Patient undergoing coronary angiography or PCI for NSTE-ACS
2. Requirement for CIN prophylaxis as per Barts Heart Centre Criteria for CIN prophylaxis:
- eGFR less than 60ml/min or
- 2 of the following: diabetes, liver failure(cirrhosis), age more than 70 years, exposure to contrast in last 7 days, heart failure (LVEF less than 40%), concomitant renally active drugs (ACEI, ARB, NSAIDs, aminoglycosides, diuretics)
3. Age more than or equal to 18
4. Patients able and willing to give their written informed consent 
 
ExclusionCriteria 
Details  1. ST segment elevation myocardial infarction undergoing Primary PCI
2. Patients with eGFR less than 20 ml/min or on renal replacement therapy.
3. Subjects presenting with cardiogenic shock(systolic blood pressure less than 80mmHg for more than 30 min or requiring inotropes or emergency intra aortic balloon pump for hypotension treatment) or cardiopulmonary resuscitation.
4. Current life-threatening condition other than vascular disease that may prevent a subject completing the study.
5. Use of an investigational devise or investigational drug within 30days or 5 half-life (whichever is the longer) preceding the first dose of study medication.
6. Severe acute infection.
7. Pregnancy. This will be tested by urine HcG measurement.
8. Systemic autoimmune disease such as rheumatoid arthritis or other conditions known to be associated with chronic inflammation such as inflammatory bowel disease.
9. Patients who have donated more than 500ml of blood within 56 days prior to study medication administration.
10. A history of chronic viral hepatitis(including presence of hepatitis B surface antigen or Hepatitis C antibody or other chronic hepatic disorder) or HIV.
11. Patients unable to take oral feeds.
12. Any Inclusion Criterion not met. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Incidence of CIN  Feb 2025 to April 2025 
 
Secondary Outcome  
Outcome  TimePoints 
Adverse events   5-7 days 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
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)   25/03/2025 
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="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)   Open to Recruitment 
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   Estimate the amount of nitrate present in an average beetroot and then adjust the average concentration required. The patients are selected according to the inclusion and exclusion criterion. In Test group patients started on beetroot juice day before procedure up to day 3 and Hydration regimen as recommended by ACR or EACTS. In Control group Hydration Regimen as recommended by ACR or EACTS. No dietary modifications done and restrict all nitrate containing dietary source. Risk factor questionnaire (Chyoke adapted) and Quality of life assessment (EQ 5D) assessed at Day 1 and Day 3. Iodine restricted diet for both groups. CRP is monitored from Day 1 to 5. At 3 hour Troponin and CRP determined. At 12 hour after the procedure serum creatinine and NGAL tested. 
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