A Clinical Trial of an Herbal Liquid Supplement - 'DBPS' for Managing Blood Pressure
ConditionPrehypertension
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorEetho Brands, Inc
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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).
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.
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).
Trial design
Design model
Parallel
Treatments tested in this trial
DBPS
Dietary supplementDOSE for Blood Pressure Shot (DBPS)-A proprietary oral liquid supplement formulation containing active and inactive ingredients of herbal and natural extracts.
Placebo
Other interventionAn oral liquid supplement formulation similar to the proprietary formulation but with no active ingredients.
Treatment groups
198 Participants
are divided into 3 treatment groupsGroup A: DBPS- Double doseExperimental treatment 1 intervention
Group B: DBPS -Single doseExperimental treatment 1 intervention
Group C: ComparatorPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Systolic Blood Pressure
Change from baseline to end of the study (4 weeks) in the readings of Systolic Blood Pressure.
Time frame
Week 0 & Week 4Secondary outcomes
1
Diastolic Blood Pressure (DBP)
Change from baseline to end of the study (4 weeks) in the readings of Diastolic Blood Pressure.
Time frame
Week 0 & Week 42
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)
Time frame
Week 0 & Week 43
hsCRP level
Change from baseline to end of the study (4 weeks) in the level of hsCRP biomarker in serum.
Time frame
Week 0 & Week 4Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: