â?¢To understand and analyze the effect on diabetes patients by continuing drinking alkaline water from the Alkaline ion water purifier
- Conditions
- Health Condition 1: null- Newly Diagnosed Type 2 diabetes mellitus.
- Registration Number
- CTRI/2013/08/003874
- Lead Sponsor
- Dr Deepak Gargi Pande
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 10
Newly Diagnosed Type 2 diabetes mellitus.
-Current physical examination and vital signs at screening that reveals no clinically significant abnormalities;
-Willing and able to follow the instructions and procedures of the study including water intake and other investigators instruction
-Willing to give written informed consent prior to admission into the study; and
-If female of childbearing potential, must be using a reliable form of birth control and be willing to continue as such for the duration of the study.
-Patients will be excluded from the study if they meet any of the following exclusion criteria:
-Type 1 diabetes mellitus
-Previous history of any water born disease
-Have a history suggestive of, or presence of significant, gastrointestinal, endocrine, neurological, liver, or kidney disease, or conditions known to interfere with the absorption, distribution, metabolism, or excretion of study drugs;
-Have a history of drug or alcohol dependency or psychological disease;
-Require regular use of medication (other than study medication) that interferes with the absorption and/or metabolism of study drugs (e.g., steroids);
-Have any chronic illness within 2 weeks prior to screening;
-Have known significant hepatic & renal impairment;
-Pregnant or lactating women.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method â?¢Improvement in subjectâ??s quality of life. <br/ ><br>â?¢Reduction in HbA1C, Serum insulin level, body weight, Body fat, Blood sugar fasting and Post prandial of level of the Group A and Group B. <br/ ><br>Timepoint: 16 weeks
- Secondary Outcome Measures
Name Time Method â?¢Reporting of Adverse Events (AEs) & Serious Adverse Events (SAEâ??s).Timepoint: 16 weeks