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Clinical study of Radiance therapeutic water for management of hypertension.

Phase 2
Conditions
Health Condition 1: I10- Essential (primary) hypertension
Registration Number
CTRI/2024/08/072332
Lead Sponsor
Mystic Kingdom Pvt. Ltd.
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Yet Recruiting
Sex
Not specified
Target Recruitment
0
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

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

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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