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

1 juin 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

198

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

  • Inde
    • Uttar Pradesh
      • Varanasi, Uttar Pradesh, Inde, 221002
        • Trimurti Hospital
        • Contact:
        • Chercheur principal:
          • Dr Ram Murti Singh, MD
      • Varanasi, Uttar Pradesh, Inde, 221003 ,
        • Jain Clinic
        • Contact:
        • Chercheur principal:
          • Dr Harshit Jain, MD
      • Varanasi, Uttar Pradesh, Inde, 221007
        • Kashi Medicare
        • Contact:
        • Chercheur principal:
          • Dr Manoj Kumar Srivastava, MD
      • Varanasi, Uttar Pradesh, Inde
        • Octavia Hospital
        • Contact:
        • Chercheur principal:
          • Dr Raghvendra Kumar Singh, MD

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Oui

La description

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 d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: La prévention
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Tripler

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Complément alimentaire: DBPS
DOSE for Blood Pressure Shot (DBPS)-A proprietary oral liquid supplement formulation containing active and inactive ingredients of herbal and natural extracts.
Expérimental: 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.
Complément alimentaire: DBPS
DOSE for Blood Pressure Shot (DBPS)-A proprietary oral liquid supplement formulation containing active and inactive ingredients of herbal and natural extracts.
Comparateur placebo: Comparator
An oral liquid supplement formulation similar to the proprietary formulation but with no active ingredients.
Autre: Placebo
An oral liquid supplement formulation similar to the proprietary formulation but with no active ingredients.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Systolic Blood Pressure
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Diastolic Blood Pressure (DBP)
Délai: 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)
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Eetho Brands, Inc

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

15 mai 2026

Achèvement primaire (Estimé)

30 juillet 2026

Achèvement de l'étude (Estimé)

30 août 2026

Dates d'inscription aux études

Première soumission

8 mai 2026

Première soumission répondant aux critères de contrôle qualité

1 juin 2026

Première publication (Réel)

5 juin 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

5 juin 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

1 juin 2026

Dernière vérification

1 juin 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

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

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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