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

NCT07629570 | Not Yet Recruiting

• 2 other identifiers: DOSE/PHT/01/25; Ver2.0,22Apr26CTRI/2026/02/105085
• Study Type: interventional
• Target: 198
• Locations: 1 country
• Sites: 4

Brief 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. 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.

Conditions

Prehypertension

Keywords

Elevated Blood Pressure

Outcome Measures

Primary Outcomes (1)

• Systolic Blood Pressure

  Change from baseline to end of the study (4 weeks) in the readings of Systolic Blood Pressure.

  Week 0 & Week 4

Secondary Outcomes (3)

• Diastolic Blood Pressure (DBP)

  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)

  Week 0 & Week 4

• hsCRP level

  Week 0 & Week 4

Study Arms (3)

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.

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.

Dietary Supplement: DBPS

Comparator

PLACEBO COMPARATOR

An oral liquid supplement formulation similar to the proprietary formulation but with no active ingredients.

Other: Placebo

Interventions

DBPS DIETARY_SUPPLEMENT

DOSE for Blood Pressure Shot (DBPS)-A proprietary oral liquid supplement formulation containing active and inactive ingredients of herbal and natural extracts.

DBPS -Single dose; DBPS- Double dose

Placebo OTHER

An oral liquid supplement formulation similar to the proprietary formulation but with no active ingredients.

Comparator

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eetho Brands, Inc: lead

Study Sites (4)

Trimurti Hospital

Varanasi, Uttar Pradesh, 221002, India

Location

Jain Clinic

Varanasi, Uttar Pradesh, 221003 ,, India

Location

Kashi Medicare

Varanasi, Uttar Pradesh, 221007, India

Location

Octavia Hospital

Varanasi, Uttar Pradesh, India

Location

MeSH Terms

Conditions

Prehypertension; Hypertension

Interventions

discoidin-binding polysaccharide

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Dr Manoj Kumar Srivastava, MD

CONTACT

+91-0542-2281750; manojsrivastava39@yahoo.in

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2026
• First Posted: June 5, 2026
• Study Start: May 15, 2026
• Primary Completion: July 30, 2026
• Study Completion (Estimated): August 30, 2026
• Last Updated: June 5, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

IN (4)