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CTRI Number  CTRI/2026/03/105963 [Registered on: 11/03/2026] Trial Registered Prospectively
Last Modified On: 09/03/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Behavioral 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effect of dietary salt reduction and low sodium salt substitutes on blood pressure among adults with hypertension attending urban primary care clinics in Hyderabad 
Scientific Title of Study   Effect of Dietary Salt Reduction and Low Sodium Salt Substitution on Blood Pressure among Hypertensive Adults Attending Urban Primary Care Facilities in Hyderabad A Randomized Controlled Trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  BIDUSHI BISWAS 
Designation  AcSIR PhD Scholar (UGC JRF) 
Affiliation  ICMR- NATIONAL INSTITUTE OF NUTRITION (NIN) 
Address  Room no93 Golden Jubilee Block Department of Nutrition Information Communication & Health Education ICMR – National Institute of Nutrition Jamai-Osmania PO Tarnaka Hyderabad Telangana India

Hyderabad
TELANGANA
500007
India 
Phone  4027197247  
Fax    
Email  trishabiswas003@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR CSSURYA GOUD 
Designation  SCIENTIST -C  
Affiliation  ICMR-NATIONAL INSTITUTE OF NUTRITION  
Address  ROOM NO 101 GOPALAN BLOCK GROUND FLOOR DEPARTMENT OF PUBLIC HEALTH NUTRITION BESIDE TARNAKA METRO STATION HYDERABAD TELANGANA 500007 INDIA

Hyderabad
TELANGANA
500007
India 
Phone  4027197247  
Fax    
Email  suryagoud.cs@icmr.gov.in  
 
Details of Contact Person
Public Query  
Name  DR CSSURYA GOUD 
Designation  SCIENTIST -C  
Affiliation  ICMR-NATIONAL INSTITUTE OF NUTRITION  
Address  ROOM NO 101 GOPALAN BLOCK GROUND FLOOR DEPARTMENT OF PUBLIC HEALTH NUTRITION BESIDE TARNAKA METRO STATION HYDERABAD TELANGANA 500007 INDIA

Hyderabad
TELANGANA
500007
India 
Phone  4027197247  
Fax    
Email  suryagoud.cs@icmr.gov.in  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  ICMR 
Address  Indian Council of Medical Research V. Ramalingaswami Bhawan Ansari Nagar New Delhi – 110029 India 
Type of Sponsor  Research institution 
 
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 
BIDUSHI BISWAS  ICMR -National Institute of Nutrition   Golden Jubilee Block Nutrition Information Communication and Health Education Division ICMR National Institute of Nutrition Jamai Osmania PO Tarnaka Hyderabad 500007 Telangana India
Hyderabad
TELANGANA 		 6290167567

trishabiswas003@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee,ICMR-NIN  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I10||Essential (primary) hypertension,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Low Sodium Salt Substitution   Participants will receive a low sodium salt substitute containing approximately seventy percent sodium chloride and thirty percent potassium chloride for household use. Instructions regarding appropriate quantity and method of use will be provided. Baseline serum potassium and renal function will be assessed to ensure safety prior to initiation. Duration of intervention is one month. 
Comparator Agent  Standard Dietary Advice   Participants will receive a one time printed pamphlet providing general advice on reduction of dietary salt intake as per standard public health recommendations. No individualized counselling, salt aliquots, or salt substitutes will be provided. This represents usual care in the primary health care setting. 
Intervention  Structured Dietary Salt Reduction   Participants will receive pre measured household salt quantities to facilitate reduction in discretionary salt use during cooking and at the table. In addition, structured individualized dietary counselling based on behaviour change principles will be provided to improve knowledge, motivation and practical skills for salt reduction. Participants will be advised to increase intake of potassium rich foods through natural dietary sources. Duration of intervention is one month. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  Adults aged 18 years and above
Clinical diagnosis of hypertension with or without antihypertensive medication
Systolic blood pressure 140 millimetres of mercury or higher and or diastolic blood pressure 90 millimetres of mercury or higher at screening
Primarily consume home cooked meals defined as at least two major meals cooked at home on most days of the month
Willing and able to provide written informed consent 
 
ExclusionCriteria 
Details  Use of potassium sparing diuretics
Current potassium supplementation
Known history of acute or chronic kidney disease
Baseline hyperkalemia
Pregnant or lactating women
Households with children below five years of age
Current use of low sodium salt substitute
Any medical condition considered unsafe for participation by the study medical officer
Participants planning to relocate from the study area during the trial period 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Change in systolic blood pressure measured in millimetres of mercury among hypertensive adults
 		 Measured at baseline and at the end of 1 month intervention period. 
 
Secondary Outcome  
Outcome  TimePoints 
Change in diastolic blood pressure among hypertensive adults
 		 Baseline and at 1 month 
Change in urinary sodium and potassium excretion among participants
 		 Baseline and at 1 month 
Change in urinary sodium to potassium ratio among participants
 		 Baseline and at 1 month 
Adherence to dietary salt reduction and salt substitute interventions
 		 Assessed at 1 month follow up 
 
Target Sample Size   Total Sample Size="195"
Sample Size from India="195" 
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)   01/05/2026 
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="0"
Months="1"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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   This study is a randomized parallel group controlled clinical trial designed to evaluate and compare the effects of two different dietary interventions on blood pressure among adults with hypertension attending urban primary care clinics in Hyderabad Telangana India. A total of 195 participants will be randomly allocated into three groups including a control group receiving standard dietary advice a structured salt reduction group and a low sodium salt substitute group. The intervention period will be one month . The salt reduction group will receive pre measured household salt quantities along with structured dietary counselling based on behaviour change principles . The low sodium salt substitute group will receive a salt substitute containing reduced sodium and increased potassium after baseline safety screening . 

The primary outcome is change in systolic blood pressure from baseline to one month . Secondary outcomes include change in diastolic blood pressure urinary sodium and potassium excretion sodium potassium ratio and adherence to the intervention . The study will provide evidence on the effectiveness and feasibility of these household level sodium reduction strategies in urban care settings .
 
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