PrehypertensionNCT07629570
A Clinical Trial of an Herbal Liquid Supplement - 'DBPS' for Managing Blood Pressure
A study testing DBPS in people with Prehypertension, run by Eetho Brands, Inc at 4 sites in India.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Prehypertension
- What is being tested?
- DBPS
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 198 participants
- Where
- 4 sitesIndia
- Study dates
- 15 May 2026to 30 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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:
- Myocardial infarction, stroke, or transient ischemic attack within the past 6 months.
- Symptomatic heart failure or left ventricular ejection fraction less than 40%.
- Cases of class III and class IV congestive heart failure (CHF) as defined by the New York Heart Association.
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- Unstable angina pectoris or revascularization procedure within the past 3 months.
- 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).
- 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.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
India4 sites
Trimurti Hospital
Varanasi, Uttar Pradesh, 221002
Dr. Ram Murti Singh, MD, +91-9415221720, ram.trimurti@gmail.com
Dr Ram Murti Singh, MD
Jain Clinic
Varanasi, Uttar Pradesh, 221003 ,
Dr. Harshit Jain, MD, +91-9793036567, harsh656@gmail.com
Dr Harshit Jain, MD
Kashi Medicare
Varanasi, Uttar Pradesh, 221007
Dr Manoj Kumar Srivastava Srivastava, MD, +91-0542-2281750, manojsrivastava39@yahoo.in
Dr Manoj Kumar Srivastava, MD
Octavia Hospital
Varanasi, Uttar Pradesh
Dr Raghvendra Kumar Singh, MD, +91-8765548689, raghvendras069@gmail.com
Dr Raghvendra Kumar Singh, MD
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Prehypertension
- Being tested
- DBPS, Placebo
- Keywords
- Elevated Blood Pressure
- Medical subject headings
- Prehypertension, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DBPSDietary supplement
DOSE for Blood Pressure Shot (DBPS)-A proprietary oral liquid supplement formulation containing active and inactive ingredients of herbal and natural extracts.
PlaceboOther
An oral liquid supplement formulation similar to the proprietary formulation but with no active ingredients.
| Study group | Role | What they receive |
|---|---|---|
| DBPS- Double dose | Experimental | DOSE for Blood Pressure Shot (DBPS)-A proprietary oral liquid supplement formulation containing active and inactive ingredients of herbal and natural extracts. Receives: Dietary Supplement: DBPS |
| DBPS -Single dose | Experimental | DOSE for Blood Pressure Shot (DBPS)-A proprietary oral liquid supplement formulation containing active and inactive ingredients of herbal and natural extracts. Receives: Dietary Supplement: DBPS |
| Comparator | Placebo comparator | An oral liquid supplement formulation similar to the proprietary formulation but with no active ingredients. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systolic Blood Pressure
Change from baseline to end of the study (4 weeks) in the readings of Systolic Blood Pressure.
Measured: Week 0 & Week 4
Secondary outcomes (3)
Diastolic Blood Pressure (DBP)
Change from baseline to end of the study (4 weeks) in the readings of Diastolic Blood Pressure.
Measured: 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)
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)
Measured: Week 0 & Week 4
hsCRP level
Change from baseline to end of the study (4 weeks) in the level of hsCRP biomarker in serum.
Measured: Week 0 & Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2026
- Study start15 May 2026 (estimated)
- Primary completion30 Jul 2026 (estimated)
- Study completion30 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrehypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 198 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eetho Brands, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07629570
- Sponsor's protocol ID
- DOSE/PHT/01/25; Ver2.0,22Apr26
- Other IDs
- CTRI/2026/02/105085
- Status last verified
- Jun 2026
- First submitted
- 8 May 2026
- Last updated
- 5 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT07629570
- Acronym / sponsor ID
- DOSE/PHT/01/25; Ver2.0,22Apr26
- Conditions
- Prehypertension
- Keywords
- Elevated Blood Pressure
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 198 participants (estimated)
- Lead sponsor
- Eetho Brands, IncIndustry (pharma, biotech, devices)
- Study start
- 15 May 2026 (estimated)
- Primary completion
- 30 Jul 2026 (estimated)
- Study completion
- 30 Aug 2026 (estimated)
- First posted
- 5 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| DBPS- Double dose | Experimental | Dietary Supplement: DBPSDOSE for Blood Pressure Shot (DBPS)-A proprietary oral liquid supplement formulation containing active and inactive ingredients of herbal and natural extracts. |
| DBPS -Single dose | Experimental | Dietary Supplement: DBPSDOSE for Blood Pressure Shot (DBPS)-A proprietary oral liquid supplement formulation containing active and inactive ingredients of herbal and natural extracts. |
| Comparator | Placebo comparator | Other: PlaceboAn oral liquid supplement formulation similar to the proprietary formulation but with no active ingredients. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (21 listed)
- 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:
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DBPSDOSE for Blood Pressure Shot (DBPS)-A proprietary oral liquid supplement formulation containing active and inactive ingredients of herbal and natural extracts. | Dietary supplement | DBPS -Single dose, DBPS- Double dose |
| PlaceboAn oral liquid supplement formulation similar to the proprietary formulation but with no active ingredients. | Other | Comparator |
Primary outcome
Systolic Blood Pressure
Time frame: Week 0 & Week 4
Change from baseline to end of the study (4 weeks) in the readings of Systolic Blood Pressure.
3 secondary outcomes
Diastolic Blood Pressure (DBP)
Time frame: 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)
Time frame: Week 0 & Week 4
hsCRP level
Time frame: Week 0 & Week 4
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DBPS in people with Prehypertension, run by Eetho Brands, Inc at 4 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr Manoj Kumar Srivastava, MD (+91-0542-2281750, manojsrivastava39@yahoo.in), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Systolic Blood Pressure (time frame: Week 0 & Week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2026.