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

1 juni 2026 uppdaterad av: 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.

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Beräknad)

198

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

  • Indien
    • Uttar Pradesh
      • Varanasi, Uttar Pradesh, Indien, 221002
        • Trimurti Hospital
        • Kontakt:
        • Huvudutredare:
          • Dr Ram Murti Singh, MD
      • Varanasi, Uttar Pradesh, Indien, 221003 ,
        • Jain Clinic
        • Kontakt:
        • Huvudutredare:
          • Dr Harshit Jain, MD
      • Varanasi, Uttar Pradesh, Indien, 221007
        • Kashi Medicare
        • Kontakt:
        • Huvudutredare:
          • Dr Manoj Kumar Srivastava, MD
      • Varanasi, Uttar Pradesh, Indien
        • Octavia Hospital
        • Kontakt:
        • Huvudutredare:
          • Dr Raghvendra Kumar Singh, MD

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Ja

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Förebyggande
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Trippel

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.
Kosttillskott: DBPS
DOSE for Blood Pressure Shot (DBPS)-A proprietary oral liquid supplement formulation containing active and inactive ingredients of herbal and natural extracts.
Experimentell: 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.
Kosttillskott: DBPS
DOSE for Blood Pressure Shot (DBPS)-A proprietary oral liquid supplement formulation containing active and inactive ingredients of herbal and natural extracts.
Placebo-jämförare: Comparator
An oral liquid supplement formulation similar to the proprietary formulation but with no active ingredients.
Övrig: Placebo
An oral liquid supplement formulation similar to the proprietary formulation but with no active ingredients.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Systolic Blood Pressure
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Diastolic Blood Pressure (DBP)
Tidsram: 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)
Tidsram: 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
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Eetho Brands, Inc

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

15 maj 2026

Primärt slutförande (Beräknad)

30 juli 2026

Avslutad studie (Beräknad)

30 augusti 2026

Studieregistreringsdatum

Först inskickad

8 maj 2026

Först inskickad som uppfyllde QC-kriterierna

1 juni 2026

Första postat (Faktisk)

5 juni 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

5 juni 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

1 juni 2026

Senast verifierad

1 juni 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

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

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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