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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Prehypertension
• Intervention / Treatment: Dietary supplement: DBPS; Other: Placebo

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 Type: Interventional
• Enrollment (Estimated): 198
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dr Manoj Kumar Srivastava, MD; Phone Number: +91-0542-2281750; Email: manojsrivastava39@yahoo.in

Study Locations

• India
  • Uttar Pradesh
    • Varanasi, Uttar Pradesh, India, 221002
      • Trimurti Hospital
      • Contact: Dr. Ram Murti Singh, MD; Phone Number: +91-9415221720; Email: ram.trimurti@gmail.com
      • Principal Investigator: Dr Ram Murti Singh, MD
    • Varanasi, Uttar Pradesh, India, 221003 ,
      • Jain Clinic
      • Contact: Dr. Harshit Jain, MD; Phone Number: +91-9793036567; Email: harsh656@gmail.com
      • Principal Investigator: Dr Harshit Jain, MD
    • Varanasi, Uttar Pradesh, India, 221007
      • Kashi Medicare
      • Contact: Dr Manoj Kumar Srivastava Srivastava, MD; Phone Number: +91-0542-2281750; Email: manojsrivastava39@yahoo.in
      • Principal Investigator: Dr Manoj Kumar Srivastava, MD
    • Varanasi, Uttar Pradesh, India
      • Octavia Hospital
      • Contact: Dr Raghvendra Kumar Singh, MD; Phone Number: +91-8765548689; Email: raghvendras069@gmail.com
      • Principal Investigator: Dr Raghvendra Kumar Singh, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Dietary supplement: DBPS; DOSE for Blood Pressure Shot (DBPS)-A proprietary oral liquid supplement formulation containing active and inactive ingredients of herbal and natural extracts.
Experimental: 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.	Dietary supplement: DBPS; DOSE for Blood Pressure Shot (DBPS)-A proprietary oral liquid supplement formulation containing active and inactive ingredients of herbal and natural extracts.
Placebo Comparator: Comparator; An oral liquid supplement formulation similar to the proprietary formulation but with no active ingredients.	Other: Placebo; An oral liquid supplement formulation similar to the proprietary formulation but with no active ingredients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diastolic Blood Pressure (DBP)	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)	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	Change from baseline to end of the study (4 weeks) in the level of hsCRP biomarker in serum.	Week 0 & Week 4

Collaborators and Investigators

• Sponsor: Eetho Brands, Inc

Study record dates

Study Major Dates

• Study Start (Estimated): May 15, 2026
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): August 30, 2026

Study Registration Dates

• First Submitted: May 8, 2026
• First Submitted That Met QC Criteria: June 1, 2026
• First Posted (Actual): June 5, 2026

Study Record Updates

• Last Update Posted (Actual): June 5, 2026
• Last Update Submitted That Met QC Criteria: June 1, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Elevated Blood Pressure
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Hypertension; Prehypertension; discoidin-binding polysaccharide
• Other Study ID Numbers: DOSE/PHT/01/25; Ver2.0,22Apr26; CTRI/2026/02/105085 (Other Identifier: Clinical Trial Registry, India)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No