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

1 de junio de 2026 actualizado por: Eetho Brands, Inc

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.

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.

Descripción general del estudio

Estado

Aún no reclutando

Condiciones

Intervención / Tratamiento

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

198

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Ubicaciones de estudio

  • India
    • Uttar Pradesh
      • Varanasi, Uttar Pradesh, India, 221002
        • Trimurti Hospital
        • Contacto:
        • Investigador principal:
          • Dr Ram Murti Singh, MD
      • Varanasi, Uttar Pradesh, India, 221003 ,
        • Jain Clinic
        • Contacto:
          • Dr. Harshit Jain, MD
          • Número de teléfono: +91-9793036567
          • Correo electrónico: harsh656@gmail.com
        • Investigador principal:
          • Dr Harshit Jain, MD
      • Varanasi, Uttar Pradesh, India, 221007
        • Kashi Medicare
        • Contacto:
        • Investigador principal:
          • Dr Manoj Kumar Srivastava, MD
      • Varanasi, Uttar Pradesh, India
        • Octavia Hospital
        • Contacto:
        • Investigador principal:
          • Dr Raghvendra Kumar Singh, MD

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

Sí

Descripción

Inclusion Criteria:

  1. Men and women between the ages 18 and 65 years, inclusive, at the time of signing the informed consent.
  2. 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.
  3. 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).
  4. Body Mass Index less than 30 kg/m2.
  5. 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.
  6. Provide written informed consent to participate in the study after all procedures have been fully explained and questions answered.
  7. Willing and able to comply with all study procedures, visit schedules, and restrictions.

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Prevención
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Triple

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: DBPS- Double dose
DOSE for Blood Pressure Shot (DBPS)-A proprietary oral liquid supplement formulation containing active and inactive ingredients of herbal and natural extracts.
Suplemento dietético: DBPS
DOSE for Blood Pressure Shot (DBPS)-A proprietary oral liquid supplement formulation containing active and inactive ingredients of herbal and natural extracts.
Experimental: DBPS -Single dose
DOSE for Blood Pressure Shot (DBPS)-A proprietary oral liquid supplement formulation containing active and inactive ingredients of herbal and natural extracts.
Suplemento dietético: DBPS
DOSE for Blood Pressure Shot (DBPS)-A proprietary oral liquid supplement formulation containing active and inactive ingredients of herbal and natural extracts.
Comparador de placebos: Comparator
An oral liquid supplement formulation similar to the proprietary formulation but with no active ingredients.
Otro: Placebo
An oral liquid supplement formulation similar to the proprietary formulation but with no active ingredients.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Systolic Blood Pressure
Periodo de tiempo: Week 0 & Week 4
Change from baseline to end of the study (4 weeks) in the readings of Systolic Blood Pressure.
Week 0 & Week 4

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Diastolic Blood Pressure (DBP)
Periodo de tiempo: Week 0 & Week 4
Change from baseline to end of the study (4 weeks) in the readings of Diastolic Blood Pressure.
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)
Periodo de tiempo: Week 0 & Week 4
Change from baseline to end of the study (4 weeks) in the readings of Systolic and Diastolic Blood Pressure (SBP and DBP) as recorded by a twenty- four hour-ambulatory blood pressure monitor (24hr ABPM)
Week 0 & Week 4
hsCRP level
Periodo de tiempo: Week 0 & Week 4
Change from baseline to end of the study (4 weeks) in the level of hsCRP biomarker in serum.
Week 0 & Week 4

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Eetho Brands, Inc

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

15 de mayo de 2026

Finalización primaria (Estimado)

30 de julio de 2026

Finalización del estudio (Estimado)

30 de agosto de 2026

Fechas de registro del estudio

Enviado por primera vez

8 de mayo de 2026

Primero enviado que cumplió con los criterios de control de calidad

1 de junio de 2026

Publicado por primera vez (Actual)

5 de junio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

5 de junio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

1 de junio de 2026

Última verificación

1 de junio de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • DOSE/PHT/01/25; Ver2.0,22Apr26
  • CTRI/2026/02/105085 (Otro identificador: Clinical Trial Registry, India)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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