| CTRI Number |
CTRI/2026/02/105085 [Registered on: 27/02/2026] Trial Registered Prospectively |
| Last Modified On: |
04/05/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A clinical trial of an herbal liquid supplement (DBPS) for managing blood pressure. |
|
Scientific Title of Study
|
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of DOSE for Blood Pressure Shot in Prehypertensive Subjects |
| Trial Acronym |
NIL |
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| DOSE/PHT/01/25; Version 2.0, Date: 22 April 2026 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Manoj Kumar Srivastava |
| Designation |
Principal Investigator |
| Affiliation |
Kashi Medicare |
| Address |
Ground Floor, Room No.1, Department of General Medicine,
Pandeypur,Paharia
Varanasi
UTTAR PRADESH
221007
India |
| Phone |
05422281750 |
| Fax |
|
| Email |
manojsrivastava39@yahoo.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ghanashyam Patel |
| Designation |
Head, R&D |
| Affiliation |
Eetho Brands Inc. |
| Address |
Ground Floor, Room No.1,
Department-Research & Development
Atladara-Padra Main Road
Vadodara
GUJARAT
390012
India |
| Phone |
9824654050 |
| Fax |
|
| Email |
patel.drg@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ghanashyam Patel |
| Designation |
Head, R&D |
| Affiliation |
Eetho Brands Inc. |
| Address |
Ground Floor, Room No.1,
Department-Research & Development
Atladara-Padra Main Road
Vadodara
GUJARAT
390012
India |
| Phone |
9824654050 |
| Fax |
|
| Email |
patel.drg@gmail.com |
|
|
Source of Monetary or Material Support
|
| Eetho Brands Inc.
51, NE 24th street suit 206, Miami,
FL-33137, USA
|
|
|
Primary Sponsor
|
| Name |
Eetho Brands Inc. |
| Address |
51, NE 24th street suit 206, Miami, FL-33137, USA |
| Type of Sponsor |
Other [Herbal & Nutraceutical Manufactures ] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Harshit Jain |
Dr. Ashwini Kumar Jain Clinic |
Ground Floor, Room No. 2, Department of General Medicine, Maldahia,Chetganj
Varanasi
UTTAR PRADESH |
9793036567
harsh656@gmail.com |
| Dr Manoj Kumar Srivastava |
Kashi Medicare |
Ground Floor, Room No.1, Department of General Medicine,Ashok Vihar Colony,
Paharia
Varanasi
UTTAR PRADESH |
0542-2281750
manojsrivastava39@yahoo.in |
| Dr Raghvendra Kumar Singh |
Octivia Hospital |
First Floor, Room No.2, Department of General Medicine, Bharlai,Shivpur
Varanasi
UTTAR PRADESH |
8765548689
raghvendras069@gmail.com |
| Dr Ram Murti Singh |
Trimurti Hospital |
Ground Floor, RoomNo.5, Department of General Medicine, Gilat Bazar, Bhojuveer
Varanasi
UTTAR PRADESH |
9415221720
ram.trimurti@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Shivnath Hospital Private Limited |
Approved |
| Institutional Ethics Committee Shivnath Hospital Private Limited |
Approved |
| Institutional Ethics Committee Shivnath Hospital Private Limited |
Approved |
| Institutional Ethics Committee Shivnath Hospital Private Limited |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Pre-hypertension |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
DOSE for Blood Pressure Shot (DBPS) |
A proprietary oral liquid supplement formulation containing active and inactive ingredients of herbal and natural extracts. |
| Comparator Agent |
Placebo |
An oral liquid supplement formulation similar to the proprietary formulation but with no active ingredients. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
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. |
|
| ExclusionCriteria |
| Details |
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. |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change from baseline to end of the study (4 weeks) in the readings of Systolic Blood Pressure. |
Week 0 & Week 4 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Change from baseline to end of the study (4 weeks) in the readings of:
(i) Diastolic Blood Pressure (DBP)
(ii) Systolic and Diastolic Blood Pressure (SBP and DBP) as recorded by a twenty four hour-ambulatory blood pressure monitoring (24 hr ABPM) device
(iii) Quality of life Questionnaire scores
(iv) hsCRP level
(v) Safety laboratory parameters (clinical chemistry, haematology, urinalysis and ECG parameters)
(vi) Incidences of Adverse Events (AEs) recorded during the study |
Week 0 & Week 4 |
|
|
Target Sample Size
|
Total Sample Size="198"
Sample Size from India="198"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="198" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
11/05/2026 |
| Date of Study Completion (India) |
31/08/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
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. 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. |