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A Preliminary Trial of Safety and Reducing Blood Pressure of Formula Salt With Limited Sodium Named ManLiKang in Hypertension Patients.

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ClinicalTrials.gov Identifier: NCT03226327
Recruitment Status : Not yet recruiting
First Posted : July 21, 2017
Last Update Posted : July 24, 2017
Sponsor:
Information provided by (Responsible Party):
Yangfeng Wu, Peking University

Brief Summary:
This study is an one arm, self-controlled preliminary trial. Hypertension patients will be categorized into three types, not taking antihypertension drugs with normal renal function, taking antihypertension drugs with normal renal function, and taking antihypertension drugs or not with abnormal renal function. Each category includes 30 hypertension patients. Based on renal function, 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 limited sodium ManLiKang in six weeks, and will be followed up at 1, 2, 4 and 6 weeks to assess the safety, the effect of reducing blood pressure and the change of 24-hour urine sodium.

Condition or disease Intervention/treatment Phase
Hypertension Formula Salt With Limited Sodium Dietary Supplement: formula salt with limited sodium named ManLiKang Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Preliminary Trial of Safety and Reducing Blood Pressure of Formula Salt With Limited Sodium Named ManLiKang in Hypertension Patients.
Estimated Study Start Date : August 1, 2017
Estimated Primary Completion Date : September 15, 2017
Estimated Study Completion Date : October 10, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sodium

Arm Intervention/treatment
Experimental: hypertension patients Dietary Supplement: formula salt with limited sodium named ManLiKang
hypertension patients will use the formula salt with limited sodium ManLiKang in six weeks, and will be followed up at 1, 2, 4 and 6 weeks to assess the safety, the effect of reducing blood pressure and the change of 24-hour urine sodium.




Primary Outcome Measures :
  1. change in blood pressure [ Time Frame: baseline and 6 weeks ]
    the change of blood pressure before and after using formula salt with limited sodium ManLiKang


Secondary Outcome Measures :
  1. change in 24-hour urine sodium [ Time Frame: baseline and 6 weeks ]
    the change of 24-hour urine sodium before and after formula salt with limited sodium ManLiKang

  2. rate of reducing antihypertensive drug dose [ Time Frame: up to 6 weeks ]
    the number of people who will reduce antihypertensive drug dose after use formula salt with limited sodium.

  3. rate of reaching the normal blood pressure [ Time Frame: up to 6 weeks ]
    blood pressure reaches the standard of systolic pressure<140mmHg and diastolic pressure<90mmHg after using formula salt with limited sodium.

  4. adverse event [ Time Frame: up to 6 weeks ]
    the adverse events after using formula salt with limited sodium



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Ages Eligible for Study:   50 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  • The family of using the low sodium salt
  • Not willing to use the formula salt with limited sodium in family
  • Liver disfunction
  • Anyone with abnormal serum potassium in family
  • Anyone using potassium-retaining diuretics in family

Responsible Party: Yangfeng Wu, director, Peking University
ClinicalTrials.gov Identifier: NCT03226327     History of Changes
Other Study ID Numbers: PUCRI20170716
First Posted: July 21, 2017    Key Record Dates
Last Update Posted: July 24, 2017
Last Verified: July 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases