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

1. juni 2026 oppdatert 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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Antatt)

198

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • India
    • Uttar Pradesh
      • Varanasi, Uttar Pradesh, India, 221002
        • Trimurti Hospital
        • Ta kontakt med:
        • Hovedetterforsker:
          • Dr Ram Murti Singh, MD
      • Varanasi, Uttar Pradesh, India, 221003 ,
        • Jain Clinic
        • Ta kontakt med:
        • Hovedetterforsker:
          • Dr Harshit Jain, MD
      • Varanasi, Uttar Pradesh, India, 221007
        • Kashi Medicare
        • Ta kontakt med:
        • Hovedetterforsker:
          • Dr Manoj Kumar Srivastava, MD
      • Varanasi, Uttar Pradesh, India
        • Octavia Hospital
        • Ta kontakt med:
        • Hovedetterforsker:
          • Dr Raghvendra Kumar Singh, MD

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Ja

Beskrivelse

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Trippel

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Kosttilskudd: DBPS
DOSE for Blood Pressure Shot (DBPS)-A proprietary oral liquid supplement formulation containing active and inactive ingredients of herbal and natural extracts.
Eksperimentell: 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.
Kosttilskudd: DBPS
DOSE for Blood Pressure Shot (DBPS)-A proprietary oral liquid supplement formulation containing active and inactive ingredients of herbal and natural extracts.
Placebo komparator: Comparator
An oral liquid supplement formulation similar to the proprietary formulation but with no active ingredients.
Annen: Placebo
An oral liquid supplement formulation similar to the proprietary formulation but with no active ingredients.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Systolic Blood Pressure
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Diastolic Blood Pressure (DBP)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Eetho Brands, Inc

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

15. mai 2026

Primær fullføring (Antatt)

30. juli 2026

Studiet fullført (Antatt)

30. august 2026

Datoer for studieregistrering

Først innsendt

8. mai 2026

Først innsendt som oppfylte QC-kriteriene

1. juni 2026

Først lagt ut (Faktiske)

5. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

5. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

1. juni 2026

Sist bekreftet

1. juni 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

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

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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