A Clinical Trial of an Herbal Liquid Supplement - 'DBPS' for Managing Blood Pressure
1 giugno 2026 aggiornato da: 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.
Panoramica dello studio
Stato
Non ancora reclutamento
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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 di studio
Interventistico
Iscrizione (Stimato)
198
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Contatto studio
- Nome: Dr Manoj Kumar Srivastava, MD
- Numero di telefono: +91-0542-2281750
- Email: manojsrivastava39@yahoo.in
Luoghi di studio
-
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Uttar Pradesh
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Varanasi, Uttar Pradesh, India, 221002
- Trimurti Hospital
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Contatto:
- Dr. Ram Murti Singh, MD
- Numero di telefono: +91-9415221720
- Email: ram.trimurti@gmail.com
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Investigatore principale:
- Dr Ram Murti Singh, MD
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Varanasi, Uttar Pradesh, India, 221003 ,
- Jain Clinic
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Contatto:
- Dr. Harshit Jain, MD
- Numero di telefono: +91-9793036567
- Email: harsh656@gmail.com
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Investigatore principale:
- Dr Harshit Jain, MD
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Varanasi, Uttar Pradesh, India, 221007
- Kashi Medicare
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Contatto:
- Dr Manoj Kumar Srivastava Srivastava, MD
- Numero di telefono: +91-0542-2281750
- Email: manojsrivastava39@yahoo.in
-
Investigatore principale:
- Dr Manoj Kumar Srivastava, MD
-
Varanasi, Uttar Pradesh, India
- Octavia Hospital
-
Contatto:
- Dr Raghvendra Kumar Singh, MD
- Numero di telefono: +91-8765548689
- Email: raghvendras069@gmail.com
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Investigatore principale:
- Dr Raghvendra Kumar Singh, MD
-
-
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Sì
Descrizione
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Triplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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.
|
DOSE for Blood Pressure Shot (DBPS)-A proprietary oral liquid supplement formulation containing active and inactive ingredients of herbal and natural extracts.
|
|
Sperimentale: 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.
|
DOSE for Blood Pressure Shot (DBPS)-A proprietary oral liquid supplement formulation containing active and inactive ingredients of herbal and natural extracts.
|
|
Comparatore placebo: Comparator
An oral liquid supplement formulation similar to the proprietary formulation but with no active ingredients.
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An oral liquid supplement formulation similar to the proprietary formulation but with no active ingredients.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Systolic Blood Pressure
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Diastolic Blood Pressure (DBP)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Stimato)
15 maggio 2026
Completamento primario (Stimato)
30 luglio 2026
Completamento dello studio (Stimato)
30 agosto 2026
Date di iscrizione allo studio
Primo inviato
8 maggio 2026
Primo inviato che soddisfa i criteri di controllo qualità
1 giugno 2026
Primo Inserito (Effettivo)
5 giugno 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
5 giugno 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
1 giugno 2026
Ultimo verificato
1 giugno 2026
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- DOSE/PHT/01/25; Ver2.0,22Apr26
- CTRI/2026/02/105085 (Altro identificatore: Clinical Trial Registry, India)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .