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

Официальное название

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of DOSE for Blood Pressure Shot (DBPS) in Prehypertensive Subjects.

Обзор

Prehypertension is a clinical condition characterized by systolic blood pressure (SBP) readings between 120 and 139 mmHg and/or diastolic blood pressure (DBP) readings between 80 and 89 mmHg, as per the Joint National Committee (JNC 7) and World Health Organization (WHO) guidelines. Individuals falling within this range do not yet meet the criteria for hypertension but are at a significantly elevated risk of progressing to full-blown hypertension and developing associated cardiovascular diseases such as heart attack and stroke. This stage is considered as a critical window for intervention, as timely and appropriate measures can potentially halt or delay the progression to more severe health issues.

Подробное описание

This is a randomized, double-blind, placebo-controlled, parallel-group study to evaluate the effectiveness of 4-week supplementation regimen of 'DOSE for Blood Pressure Shot (DBPS)' in reducing systolic and diastolic blood pressure among prehypertensive adults. DBPS is formulated as a liquid oral supplement specifically designed to support cardiovascular wellbeing. The product is rooted in both preliminary scientific evidence and traditional medicinal practices, which indicate that it may exert blood-pressure lowering effects by influencing vascular tone and modulating inflammatory pathways within the body. The active ingredients in DBPS are believed to help relax blood vessels, improve endothelial function, and reduce systemic inflammation, all of which contribute to healthier blood pressure levels.

Вмешательства

• Пищевая добавка DBPS
  DOSE for Blood Pressure Shot (DBPS)-A proprietary oral liquid supplement formulation containing active and inactive ingredients of herbal and natural extracts.
• Другое Placebo
  An oral liquid supplement formulation similar to the proprietary formulation but with no active ingredients.

Первичные конечные точки

• Systolic Blood Pressure [Срок оценки: Week 0 & Week 4]

Вторичные конечные точки (3)

• Diastolic Blood Pressure (DBP) [Срок оценки: Week 0 & Week 4]
• Systolic and Diastolic Blood Pressure (SBP and DBP) as recorded by a twenty- four hour-ambulatory blood pressure monitor (24hr ABPM) [Срок оценки: Week 0 & Week 4]
• hsCRP level [Срок оценки: Week 0 & Week 4]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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).
• 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.

• 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.
• 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).
• Any chronic diseases that may interfere with study participation or pose additional risk to the subject.
• A tobacco smoker or user of nicotine products in the 6 months prior to screening.
• Excessive alcohol consumption (Men more than 14 drinks/week and women more than 7 drinks/week).
• History of substance abuse or dependency within the last 1 year.
• Women who are pregnant or lactating.
• History of hypersensitivity or contraindication to the test product (DBPS) or any of its components or placebo.
• Participation in another clinical research study involving an investigational product within 30 days prior to screening or during the current study.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Профилактика

Центры проведения

Индия · 4 центра

• Trimurti Hospital — Varanasi
• Jain Clinic — Varanasi
• Kashi Medicare — Varanasi
• Octavia Hospital — Varanasi

Идентификаторы

NCT: NCT07629570 · DOSE/PHT/01/25; Ver2.0,22Apr26 · CTRI/2026/02/105085

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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