Health Condition 1: I10- Essential (primary) hypertension
Conditions
Interventions
Intervention1: Dose for Blood Pressure Shot: To assess the safety and tolerability of the intervention Dose for Blood Pressure Shot 59ml.
Dose: 59 mL
Mode: Orally
Frequency: Once daily OD or twice dai
Sponsors
Eetho Brands Inc
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male and female aged between 40 and 65 years inclusive, at the time of signing informed consent form. 2. Seated clinic systolic blood pressure SBP 120 & 139 mmHg and diastolic blood pressure DBP 80 & 89 mmHg confirming a prehypertensive state as per JNC7 and WHO guidelines. Blood pressure will be determined by repeated measurements using a mercury sphygmomanometer Refer Appendix 1. 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 30 kgm2. 5.Female of childbearing potential WOCBP must agree to use a highly effective method of contraception e.g., oral contraceptives, intrauterine device, surgical sterilization from screening until the end of the study. Female who are postmenopausal defined as amenorrhea for at least 12 consecutive month or surgically sterile are eligible. 6.Ability and willingness to provide written informed consent to participate in the study after all procedures have been fully explained and questions have been answered. 7.Willing and able to comply with all study procedures, visit schedules, and study-related restrictions.
Exclusion criteria
Exclusion criteria: 1.Diagnosed with Stage 1 Hypertension SBP139 mmHg or DBP89 mmHg or Stage 2 Hypertension 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 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 6. History of uncontrolled diabetes mellitus e.g. HbA1c 7 0 or other chronic diseases that may interfere with study participation or pose additional risk to the participant. 7. Current smoker or use of nicotine products. Define as self reported tobacco or nicotine use including cigarettes, bidis, chewing tobacco, e cigarettes vapes, nicotine gum patches within the 30 days prior to screening, or intention to use during study participation. 8. Excessive alcohol consumption 2 alcoholic drinks per day for men and greater than 1 alcoholic drink per day for female. 9.History of substance abuse or dependency within the last 2 years. 10.Female who are pregnant or lactating. 11.History of hypersensitivity or contraindication to the test product Dose for Blood Pressure Shot 59 mL or any of its components or placebo. 12.Participation in another clinical research study involving an investigational product within 30 days prior to screening or during the current study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Mean Systolic Blood Pressure SBP assessed by 24hour Ambulatory Blood Pressure Monitoring ABPM.Timepoint: baseline to end of treatment at Visit 4 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in Mean Diastolic Blood Pressure DBP assessed by 24 hour Ambulatory Blood Pressure Monitoring ABPM from baseline to end of treatment at Visit 4. Change in Systolic Blood Pressure SBP & Diastolic Blood Pressure DBP from baseline to end of treatment at Visit 4 SBP & DBP at Visit 4, & responder rate. Change in Endothelial Function Biomarker high sensitivity Creactive protein hsCRP, Serum ESelectin, & Serum Endothelin1 levels from baseline to end of treatment at Visit 4. Change in serum nitrate levels from baseline to end of treatment at Visit 4. Change in hand grip strength from baseline to end of treatment at Visit 4. Change in endothelial function, assessed by flowmediated dilation FMD measured using ultrasound, from baseline to end of treatment at Visit 4. Change in health-related quality of life HR QoL, assessed using a validated quality of life questionnaire, from Visit 2 through Visit 4. Timepoint: From baseline visit 2 to end of treatment visit 4 | — |
Countries
India
Contacts
Public ContactMr Rashmin Lad
Methics Clinical Solutions Private Limited
Outcome results
None listed