A Pilot Trial of Manlikang in Reducing Salt Intake and Blood Pressure Among Patients With Hypertension

Study Overview
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Brief Summary
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This study is a single arm trial with before-after comparison design. Three groups of patients with hypertension will be recruited: not taking antihypertension drugs and having normal renal function, taking antihypertension drugs and having normal renal function, and having abnormal renal function without regards of antihypertension drugs use. Each group includes 30 patients. Based on renal function test, the investigators provide the Manlikang containing potassium chloride to patients with normal renal function, and provide the Manlikang not containing potassium chloride to patients with abnormal renal function. All hypertension patients will use the formula salt with very low sodium (Manlikang) for six weeks, and will be followed up at 1, 2, 4 and 6 weeks. The primary outcome will be the decrease of patients' systolic blood pressure at the end of the trial.

Official Title
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A Pilot Trial on Efficacy and Safety of a Formula Salt With Very Low Sodium (Manlikang) in Reducing Salt Intake and Blood Pressure Among Patients With Hypertension in Community

Conditions
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Hypertension, Hypertension With Abnormal Renal Function

Intervention / Treatment
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* Dietary Supplement: formula salt with very low sodium (Brand name: Manlikang)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 50 to 75 years old No planning to move out of the community in the next three months Not cooking at home less than 3 times or one day during the study Willing to participate in the study and sign informed consent Exclusion Criteria: Acute myocardial infarction, history of stroke in the past 3 months, history of malignancy or expected lifetime less than 1 year. Hypercortisolism or aldosteronism Acute disease, such as upper respiratory infection, fever and diarrhea. Incapable of communicating, such as deaf and dumb, dementia, mental disorder. Families taking salt substitute currently Not willing to use Manlikang in family Liver disfunction Anyone with abnormal serum potassium in family Anyone using potassium-retaining diuretics in family

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: hypertension patients<br> | Dietary Supplement: formula salt with very low sodium (Brand name: Manlikang)<br>* hypertension patients will use the formula salt with very low (<20%) sodium （Manlikang) for six weeks, and will be followed up at 1, 2, 4 and 6 weeks to assess the 24-hour urine sodium.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the change of systolic pressure | the change of systolic pressure before and after taking Manlikang | baseline and 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the change in 24-hour urine sodium | the change of 24-hour urine sodium before and after taking Manlikang | baseline and 6 weeks | 
| incidence of reducing antihypertensive drug dose | the incidence of reducing antihypertensive drug dose after taking Manlikang in each group. | up to 6 weeks | 
| incidence of reaching the normal blood pressure | blood pressure reaches the standard of systolic pressure<140mmHg and diastolic pressure<90mmHg after taking Manlikang. | up to 6 weeks | 
| adverse event | the adverse events after taking Manlikang | up to 6 weeks |