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

Prior treatment

• 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.
• A tobacco smoker or user of nicotine products in the 6 months prior to screening.
• Participation in another clinical research study involving an investigational product within 30 days prior to screening or during the current study.

Other illness

• 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
• Evidence of secondary hypertension (e.g., renal artery stenosis, primary hyperaldosteronism, sleep apnea).
• Any chronic diseases that may interfere with study participation or pose additional risk to the subject.
• History of substance abuse or dependency within the last 1 year.
• History of hypersensitivity or contraindication to the test product (DBPS) or any of its components or placebo.

Lab values

• 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.
• 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).
• 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).

Other

• Excessive alcohol consumption (Men more than 14 drinks/week and women more than 7 drinks/week).
• Women who are pregnant or lactating.

• Men and women between the ages 18 and 65 years, inclusive, at the time of signing the informed consent.
• Seated clinic systolic blood pressure (SBP) in the range of 120 to 139 mm Hg and diastolic blood pressure (DBP) in the range of 80 to 89 mmHg confirming a prehypertensive state as per JNC 7 and WHO guidelines.
• In good general health as determined by a medical history, physical examination, vital signs, electrocardiogram (ECG), and routine clinical laboratory tests (hematology, clinical chemistry, urinalysis).
• Body Mass Index less than 30 kg/m2.
• Women of childbearing potential (WOCBP) must agree to use a highly effective method of contraception (e.g., oral contraceptives, intrauterine device, barrier methods with spermicide, surgical sterilization) from screening until the end of the study. Women who are postmenopausal (defined as amenorrhea for at least 12 consecutive months) or surgically sterile are eligible.
• Provide written informed consent to participate in the study after all procedures have been fully explained and questions answered.
• Willing and able to comply with all study procedures, visit schedules, and restrictions.