Health Condition 1: I10- Essential (primary) hypertension
Conditions
Interventions
None listed
Sponsors
Adret Retail Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1.Participants diagnosed with Hypertensive for more than six months with mean SBP greater than or equal to 120 but less than or equal to 150 and mean DBP greater than or equal to 80 but less than or equal to 95 mm Hg at screening. 2. Subjects willing to give informed consent & ready to comply with the protocol.
Exclusion criteria
Exclusion criteria: FOR BOTH THE COHORTS: 1. History of severe or symptomatic hypertension 2. History or evidence of a secondary form of hypertension (renal, endocrine origin, etc.) 3. History of myocardial infarction, ischemic heart disease, heart failure, rhythm disturbance or cardiomyopathy, or hemodynamically significant obstructive valvular disease. 4. Participants with clinically significant neurologic, respiratory, gastrointestinal, hepatobiliary, or hematologic disease or any type of malignancy. 5. Known cases of Diabetes Mellitus (Note- Known cases of Diabetics will be excluded from the study in cohort 1 i.e. juice cohort while participants with controlled diabetics can be recruited in cohort 2) 6. Participants with SGOT (AST) or SGPT (ALT) 2X the upper limit of normal and total bilirubin or direct bilirubin 2X the upper limit of normal 7. History of immunodeficiency diseases, including HIV, Hepatitis B or Hepatitis C 8. Pregnancy or lactation 9. Subjects with history or presence of significant alcoholism or drug abuse within the past 1 year. 10. Subjects who have participated in any clinical study within past 3 months. 11.History of allergic reaction to any of the study product ingredients 12.Other conditions, which in the opinion of the investigators, makes the patient unsuitable for enrolment or could interfere with his participation in, and completion of the protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| For Both the Cohorts: 1.Cohort 1: To assess efficacy of KARD/01/BPXJ/2026 as add-on-therapy to the ongoing medication for hypertension drug on diastolic blood pressure Cohort 2: To Assess efficacy of KARD/01/BPCT/2026 as an add on therapy to anti-hypertensive drugs on diastolic blood pressure as compared to placebo. 2.To assess efficacy of KARD/01/BPXJ/2026 and Tablets as add-on-therapy to anti-hypertensive drug (from baseline to follow up visit in both the cohorts and also between the groups in cohort 2) on quality of life to be assessed using WHO QOLBREF Timepoint: Screening Visit, Day 0, Day 30, Day 60, Day 90 and Day 180. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Chnage in systolic blood pressure 2. Change in background anti hypertensive drugs 3.Chnage in associated symptoms of hypertension 4. Change in High Sensitivity C Reactive Protein, Apolipoproteins A and B 5. Change in stress using graded scale 6. Change in satisfaction of the quality of sleep 7. Change in anxiety using graded scale 8. Change in digestion 9. Change in lipid profile 10. Global assessment for overall change by subject and investigator 11. Assessment of adverse events and vitals 12. Tolerability of study drugs 13. Safety related Laboratory parameters Timepoint: Screening Visit, Day 0, Day 30, Day 60, Day 90 and Day 180. | — |
Countries
India
Contacts
Public ContactDr Sanjay Tamoli
Target Institute of Medical Education and Research Pvt. Ltd
Outcome results
None listed