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CTRI Number  CTRI/2024/11/077166 [Registered on: 21/11/2024] Trial Registered Prospectively
Last Modified On: 18/11/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Other 
Public Title of Study   Effect of natural and chemical based low sodium salts on the blood pressure of normal and high blood pressure participants. 
Scientific Title of Study   A randomized controlled, single blind clinical trial to investigate the beneficial effect of consumption of low sodium salts on blood pressure in healthy and hypertensive participants 
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 Sunil Panjwani 
Designation  Associate Professor  
Affiliation  Government Medical College and Sir Takhtasinhji General Hospital 
Address  Department of Medicine Government Medical College and Sir Takhtasinhji General Hospital, Bhavnagar 364001

Bhavnagar
GUJARAT
364001
India 
Phone    
Fax    
Email  spanjwani0@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Pramod Shinde 
Designation  Principal Scientist 
Affiliation  CSIR Central Salt and Marine Chemicals Research Institute 
Address  Gijubhai Badheka marg, Bhavnagar, Gujarat 364002

Bhavnagar
GUJARAT
364002
India 
Phone  7043066116  
Fax    
Email  pramodshinde@csmcri.res.in  
 
Details of Contact Person
Public Query  
Name  Dr Pramod Shinde 
Designation  Principal Scientist 
Affiliation  CSIR Central Salt and Marine Chemicals Research Institute 
Address  Gijubhai Badheka marg, Bhavnagar, Gujarat 364002


GUJARAT
364002
India 
Phone  7043066116  
Fax    
Email  pramodshinde@csmcri.res.in  
 
Source of Monetary or Material Support  
Sir Takhtasinhji General Hospital, Bhavnagar, Gujarat 364001 
 
Primary Sponsor  
Name  Dr. Sunil Panjwani 
Address  Government Medical College & Sir Takhtasinhji General Hospital, Bhavnagar-364001 
Type of Sponsor  Other [SELF] 
 
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 Sunil Panjwani  Sir Takhtasinhji General Hospital  Department of Medicine Bhavnagar-364001
Bhavnagar
GUJARAT 		 9825331039

spanjwani0@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ETHICS COMMITTEE, GOVERNMENT MEDICAL COLLEGE, BHAVNAGAR  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Systolic blood pressure around 120 mmHg and diastolic blood pressure around 80 mmHg 
Patients  (1) ICD-10 Condition: I10||Essential (primary) hypertension,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Bittern salt  Salt from sea/subsoil bittern comprising 27.55% sodium, 15.73% potassium and 50 ppm iron. 
Comparator Agent  Commercial salt  Commercial sea salt comprising 38.7% sodium. 
Intervention  Vegetable salt-I  Salt from halophytic plant comprising 33.80% sodium, 4.47% potassium, 0.370% magnesium, 0.08% calcium, 0.011% iron, 0.11% zinc, 49.94% chloride and 4.50% sulphate. 
Intervention  Vegetable salt-II  Salt from halophytic plant comprising 29.52% sodium, 15.7% potassium, 8% calcium, 7% magnesium,150 ppm Zinc, 1000 ppm iron, 50 ppm copper and 200 ppm manganese.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1 Healthy participant
2 Hypertensive participant with a systolic blood pressure 140 to 180 mmHg and diastolic blood pressure 90 to 110 mmHg 
 
ExclusionCriteria 
Details  1 Age below 18 years and above 65 years
2 Pregnant and lactating women
3 Prisoners
4 Psychiatric illness
5 Patients using potassium sparing diuretics and potassium supplements
6 Has known acute or chronic kidney disease 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Change in the systolic and diastolic blood pressure  Four  
 
Secondary Outcome  
Outcome  TimePoints 
Palatability of low sodium salts developed at CSIR- Central Salt and Marine Chemicals Research Institute  At baseline stage 
Comparison of systolic and diastolic blood pressure, serum electrolytes concentration, urine protein and electrolytes concentration, heart rate and ECG after the administration of low sodium salts and commercially available salt in the healthy and hypertensive patients   After 4 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)   03/12/2024 
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="4"
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   The study is randomized controlled, single-blind clinical trial to investigate the beneficial effect of consumption of low sodium salts on blood pressure in healthy and hypertensive participants for 4 months on 200 participants that will be conducted at single center in India. The primary outcome will be the change in systolic and diastolic blood pressure after the consumption of low sodium salts developed at CSIR- Central Salt and Marine Chemicals Research Institute. The secondary outcome will be palatability as well as the comparison of systolic and diastolic blood pressure, serum electrolytes concentration, urine protein and electrolytes concentration, heart rate and ECG after the administration of developed low sodium salts and commercially available salt in healthy and hypertensive participants.  
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