Health Condition 1: I10- Essential (primary) hypertension
Conditions
Interventions
Intervention1: Radiance therapeutic water: 1 Glass of Radiance therapeutic water (330 mL) in the morning immediately after waking up and 1 Glass of water at least 1 hour after dinner
Control Intervent
Sponsors
Mystic Kingdom Pvt. Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: Participants meeting all the following criteria will be eligible for the study: 1. Male and female patients aged between 18-50 years (both inclusive) 2. A systolic blood pressure reading greater than 140 mmHg 3. A diastolic blood pressure reading greater than 90 mmHg 4. Those on a on a stable regimen (that is same drug and same dose) of blood pressure lowering medication for greater than or equal to 3 months 5. Willing to provide consent and follow up.
Exclusion criteria
Exclusion criteria: Participants meeting any of the following criteria will not be eligible for the study: 1. Severe hypertension (systolic BP greater than 180 mm Hg or diastolic BP greater than 110 mm Hg) who needed an immediate adjustment of treatment 2. Participants with known prior hypersensitivity to the interventional products or their ingredients; 3. Participants with current heavy alcohol consumption or smoking or tobacco consumption, illicit and or recreational drug use 4. History of cancer, chronic illness, cardiovascular problems, liver and kidney disease (including chronic kidney disease, diabetes, inflammatory bowel disease, pancreatitis, gallbladder or biliary disease, neurological, psychological disease, bleeding disorders, experienced platelet abnormalities, macrovascular target organ damage (including cerebrovascular disease, stroke, hypertensive retinopathy, left ventricular dysfunction, angina pectoris, myocardial infarction, and peripheral artery disease), dementia, terminal illness, secondary hypertension, or any other recent significant medical diagnosis 5. Participation in other clinical trials in last 90 days prior to screening 6. Females who are pregnant and have a positive urine pregnancy test or planning to be pregnant or lactating or not using reliable methods of contraception 7. Any other reason that, in the opinion of the investigator, excludes the participant from eligibility for study participation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Average morning and evening systolic and diastolic blood pressure. 2. Complaints such as blurry or double vision, light headedness, fatigue, headache, heart palpitations, nosebleeds, shortness of breath, etc. in patients. 3. Changes in cold, sore throats, chest congestion severity score on 5 point Likert scale from .Timepoint: 1. Screening to the end of the study 2. Screening to the end of the study 3. Baseline to end of the study | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Changes in proportion of subjects with reduced doses of conventional treatment 2. Changes in the number of responders to treatment (Responder of treatment will be defined as participants with 10 mm/hg reduction in both systolic and diastolic BP). 3. Adverse events profile 4. Compliance and tolerability of the investigational product Timepoint: 1. Week 2, Week 4, Week 6 2. Baseline, Week 2, Week 4, Week 6 3. Week 2, Week 4, Week 6 | — |
Countries
India
Contacts
Public ContactMs Anamika Kapur
Mprex Healthcare Pvt. Ltd.
Outcome results
None listed