Clinical study on Alkaline Water in healthy subjects

Phase 1

Registration Number: CTRI/2024/06/068585

Lead Sponsor: Hydron Alkaline Aqua Pvt. Ltd.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1.Healthy Male and Female participants in the age group of 21-40 Years

2.Subjects of female gender or non-pregnant, non-lactating females. A urine pregnancy test is required for all female subjects of childbearing potential unless female subject has had a hysterectomy, tubal ligation, or is greater than 2 years postmenopausal.

3.Subjects willing to follow the procedures as per the study protocol and voluntarily sign an informed consent form.

Exclusion Criteria

1.Known cases of any Severe and Chronic disease.

2.Known subject of any active malignancy.

3.Subjects giving history of significant cardiovascular event less than 12 weeks prior to randomization.

4.Subjects having known chronic, contagious infectious disease, such as active tuberculosis, Hepatitis B or C, or HIV.

5.Known subjects of having active metabolic or gastrointestinal diseases that may interfere with nutrient absorption, metabolism, or excretion, excluding diabetes.

6.Subjects with Diabetes and Hypertension

7.Subjects using any other investigational drug within 1 month prior to recruitment.

8.Known hypersensitivity to alkaline water

9.Pregnant and Lactating females.

10.Subjects currently participating in any other Clinical study.

11.Any other condition due to which patients are deemed to be unsuitable by the investigator for reason(s) not specifically started in the exclusion criteria.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Safety related lab parameters including CBC, LFT, RFT, Blood Sugar, ECG, Sr. Electrolytes <br/ ><br>2.Safety by evaluation of adverse events based on clinical signs and symptoms <br/ ><br>Timepoint: Screening visit (Day -3), Baseline visit (Day 0), Every day till next 7 days

Secondary Outcome Measures

Name	Time	Method
1.Changes in digestion related symptoms (appetite, digestion, bowel habits) <br/ ><br>2.Change in urine output and symptoms <br/ ><br>3.Change in sleep quality <br/ ><br>4.Change in overall quality of life <br/ ><br>5.Change in level of Energy, level of stamina and physical strength <br/ ><br>6.Change in daytime fatigue using Fatigue Severity Scale (FSS) <br/ ><br>7.Change in Global evaluation for overall change on CGI-I Scale by physician and subjects <br/ ><br>8.Change in global assessment of overall safety by physician and subjectsTimepoint: Screening visit (Day -3), Baseline visit (Day 0), Every day till next 7 days