| CTRI Number |
CTRI/2025/06/089027 [Registered on: 18/06/2025] Trial Registered Prospectively |
| Last Modified On: |
15/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A New Salt Alternative to Help Manage High Blood Pressure |
|
Scientific Title of Study
|
A Prospective, Single-Arm Study to Evaluate the Effect of Suaeda fruticosa Forsk Choorna as a Table Salt Substitute on Blood Parameter in Elevated Blood Pressure Individuals |
| 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 Himanshu |
| Designation |
PG Scholar |
| Affiliation |
Parul Institute of Ayurved |
| Address |
105 Ground Floor Department Of Kriya Sharir Parul Institute Of Ayurved Parul University Limbda Waghodiya Vadodara Gujarat 391760 India
Vadodara
GUJARAT
391760
India |
| Phone |
6375537912 |
| Fax |
|
| Email |
Himanshujangir9506@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Narendra Yadnik |
| Designation |
Associate Professor |
| Affiliation |
Parul Institute of Ayurved |
| Address |
105 Ground Floor Department Of Kriya Sharir Parul Institute Of Ayurved Parul University Limbda Waghodiya Vadodara Gujarat 391760 India
Vadodara
GUJARAT
391760
India |
| Phone |
9421655695 |
| Fax |
|
| Email |
narendrayadnik@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Narendra Yadnik |
| Designation |
Associate Professor |
| Affiliation |
Parul Institute of Ayurved |
| Address |
105 Ground Floor Department Of Kriya Sharir Parul Institute Of Ayurved Parul University Limbda Waghodiya Vadodara Gujarat 391760 India
Vadodara
GUJARAT
391760
India |
| Phone |
9421655695 |
| Fax |
|
| Email |
narendrayadnik@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Parul Institute Of Ayurved |
| Address |
105 Ground floor Kriya Sharir Department Parul Institute of Ayurved
Parul University Limda waghodiya Vadodara GUJARAT 391760
India |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Himanshu |
Parul Institute Of Ayurved |
105 Ground floor Kriya
Sharir Department
Parul Institute of
Ayurved Parul
University Limda
waghodiya Vadodara
GUJARAT 391760
India
Vadodara
GUJARAT
Vadodara
GUJARAT |
6375537912
Himanshujangir9506@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PIA-IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:I10||Essential (primary) hypertension. Ayurveda Condition: RAKTAVRUTAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: SUAEDA FRUTICOSA , Reference: NA, Route: Oral, Dosage Form: Churna/ Powder, Dose: 10(g), Frequency: sos, Bhaishajya Kal: Sabhakta, Duration: 28 Days, anupAna/sahapAna: No, Additional Information: AS AMOUNT OF SALT IS PERSONAL CHOICE ITS FREQUENCY AND AMOUNT CANNOT BE FIXED, PARTICIPANT WILL DECIDE QUANTITY AS PER THE OWN TASTE |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Elevated Blood Pressure individuals between 18-60 years.
Elevated Blood Pressure individuals with baseline systolic blood pressure in between the range of 120 – 129 mmHg and diastolic blood pressure less than 80 mmHg.
Regular consumers of table salt (5g-10gm/day).
Participants who are willing to replace. conventional table salt with Suaeda fruticosa Forsk choorna and adhere to the study protocol.
Individuals who provide written informed consent to participate in the study |
|
| ExclusionCriteria |
| Details |
Individuals with known cardiovascular diseases, Stage 1, Stage 2 hypertensive crisis category hypertension, renal or metabolic disorders, or any other chronic illness.
Pregnant or breastfeeding women.
Known allergies or hypersensitivity to halophyte plants such as Suaeda fruticosa Forsk.
Individuals with recent major illnesses or surgeries in the last 3 months |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Systolic and diastolic blood pressure will be measured using a digital sphygmomanometer.
2.Serum Electrolyte levels will be measured. |
1. Systolic and diastolic blood pressure will be measured at 1st week, 2nd week and at the end of 4th week.
2.Serum Electrolyte levels will be measured at baseline and end of study. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Complete Blood Count (CBC): Includes Haemoglobin, Haematocrit, White Blood Cell Count, and Platelet Count to monitor haematological changes.
2.Overall Well-being: Self-reported questionnaire assessing physical and mental health, energy levels, and symptoms.
3.Monitoring for any adverse effects (e.g., fatigue, dizziness).
4.Palatability and Acceptability: Assessment of taste, compliance, and satisfaction with Suaeda fruticosa Forsk. as a salt substitute. |
AT BASELINE AND END OF STUDY |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
01/07/2025 |
| 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="0"
Days="28" |
|
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
|
High blood pressure, is a major health issue that increases the risk of heart disease and stroke. One of the main contributors to it, is consuming too much sodium, most commonly through table salt. This study aims to explore whether Suaeda fruticosa Forsk. choorna can be used as a substitute for regular table salt, potentially helping in blood pressure regulation and reduce sodium consumption in elevated blood pressure individuals. To evaluate the impact of Suaeda fruticosa Forsk, the following measures will be used: Blood Pressure Monitoring: Participants’ blood pressure will be measured regularly throughout the study. Serum Electrolytes and Complete Blood Count (CBC): To assess overall blood health. Well-Being Index: This questionnaire will be used to assess participants’ mental and emotional well-being In this study, participants will replace their usual table salt with Suaeda fruticosa Forsk choorna for 4 weeks. |