AN OBSERVATIONAL STUDY TO COMPARE THE EFFECT OF ALKALINE ION WATER IN PATIENTS WITH TYPE 2 DIABETES MELLITUS
- Conditions
- Health Condition 1: null- Newly Diagnosed Type 2 diabetes mellitus
- Registration Number
- CTRI/2011/12/002275
- Lead Sponsor
- Dr Deepak Gargi Pande
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 30
1.Subjects will be male or female
2.Between the age group of 40 years and above,
3.Newly Diagnosed Type 2 diabetes mellitus.
4.Current physical examination and vital signs at screening that reveals no clinically significant abnormalities;
5.Willing and able to follow the instructions and procedures of the study including water intake and other investigators instruction
7.Willing to give written informed consent prior to admission into the study; and
8.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.
1.Patients will be excluded from the study if they meet any of the following exclusion criteria:
2.Type 1 diabetes mellitus
3.Previous history of any water born disease
4.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;
5.Have a history of drug or alcohol dependency or psychological disease;
6.Require regular use of medication (other than study medication) that interferes with the absorption and/or metabolism of study drugs (e.g., steroids);
7.Have any acute illness within 2 weeks prior to screening;
8.Have known significant hepatic & renal impairment;
9.Subjects who have participated in any clinical trial or use of an investigational drug within 30 days prior to admission to this study;
10.Pregnant or lactating women
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method â?¢To audit the care of patients with type 2 diabetes mellitus after consumption of Alkaline ion purified water.Timepoint: 12 week
- Secondary Outcome Measures
Name Time Method â?¢Comparing the results of blood test of the patients consuming Alkaline Ion purified water with the patients not consuming the said water. The Test results will be recorded by doctor at different times throughout the study.Timepoint: 12 weeks