A Clinical Trial of an Herbal Liquid Supplement - 'DBPS' for Managing Blood Pressure

Exclusion Criteria

• •1. Diagnosed with Stage 1 Hypertension (SBP more than 139 mmHg or DBP more than 89 mmHg or Stage 2 Hypertension as per JNC 7 and WHO guidelines
• •2. Evidence of secondary hypertension (e.g., renal artery stenosis, primary hyperaldosteronism, sleep apnea).
• •3. History of significant cardiovascular disease, including but not limited to:
• •(i) Myocardial infarction, stroke, or transient ischemic attack within the past 6 months.
• •(ii) Symptomatic heart failure or left ventricular ejection fraction less than 40%.
• •(iii) Cases of class III and class IV congestive heart failure (CHF) as defined by the New York Heart Association.
• •(iv) Unstable angina pectoris or revascularization procedure within the past 3 months.
• •(v) Significant valvular heart disease or complex congenital heart disease by medical history.
• •4. Use of any medications (prescription, over-the-counter, herbal supplements, certain vitamins/minerals) known to affect blood pressure or interfere with study product absorption/metabolism within 14 days prior to the dosing visit, or unwillingness to stop them for the study duration.
• •5. Organ Function Impairment:
• •(i)Impaired hepatic function (Alanine aminotransferase \[ALT\] or Aspartate aminotransferase more tan 2 times the upper limit of normal \[ULN\]).
• •(ii)Impaired renal function (serum creatinine level more than 132.6 μmol/L or estimated Glomerular Filtration Rate \[eGFR\] less than 60 mL/min/1.73m2).
• •(iii) Serum potassium outside the normal range (less than 3.5 mmol/L or more than 5.5 mmol/L).
• •6. History of uncontrolled diabetes mellitus (e.g., HbA1C level more than 7.0% and/or FBS more than 125mg/dL or use of diabetes medications).
• •7. Any chronic diseases that may interfere with study participation or pose additional risk to the subject.
• •8. A tobacco smoker or user of nicotine products in the 6 months prior to screening.
• •9. Excessive alcohol consumption (Men more than 14 drinks/week and women more than 7 drinks/week).
• •10. History of substance abuse or dependency within the last 1 year.
• •11. Women who are pregnant or lactating.
• •12. History of hypersensitivity or contraindication to the test product (DBPS) or any of its components or placebo.
• •13. Participation in another clinical research study involving an investigational product within 30 days prior to screening or during the current study.