To evaluate the efficacy of Kapiva Diafree juice for the Type 2 Diabetic Patients and Improving Quality of Life
- Conditions
- Health Condition 1: E119- Type 2 diabetes mellitus without complications
- Registration Number
- CTRI/2022/04/041781
- Lead Sponsor
- Kapiva Adret Retail Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 30
1.Subjects aged > 18 years of age who agree to participate in the study willing and able to answer the questionnaire and give their written informed consent.
2. Participant with initial HBA1c value 6.5% and above
3. Subjects with a physician certified report on their sugar profile of 3 months
prior to enrolment for trial.
4. Patients with a diagnosis of T2DM for >1 year prior to signing up for clinical
trials.
5. Patients who are under the treatment of oral antidiabetic drugs
6. Patients who have not changed their medication in the last three months prior
to signing up for the study. (However, dosage modifications are allowed)
7. Subjects with Body Mass Index (BMI) >27 kg/m2 and <45 kg/m2
8. Women of childbearing potential must be willing to use double-barrier contraception for the entire study
1.Pregnant and lactating women
2. Patients who are on insulin therapy.
3. Patients with a history of chronic illness type 1 diabetes and /or history of
ketoacidosis
4. Patients with Insulin use and/or hyperosmolar hyperglycaemic state
5. Patients with secondary diabetes (including disease of the exocrine pancreas,
endocrinopathies)
6. Any condition of the patient which may have an impact on the objective and
outcome of the trial example: patients currently undergoing major/ minor surgical procedures
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method