To evaluate the efficacy of Kapiva Diafree juice for the Type 2 Diabetic Patients and Improving Quality of Life

An Open label, Single arm, clinical Study to evaluate efficacy of Kapiva Dia Free Juice as an adjuvant therapy for Type 2 Diabetic Patients and Improving QOL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2022/04/041781

Enrollment

Registered

2022-04-11

Start date

Unknown

Completion date

Unknown

Last updated

2022-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: E119- Type 2 diabetes mellitus without complications

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 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 8. Women of childbearing potential must be willing to use double-barrier contraception for the entire study

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
To evaluate Changes in the diabetic panel, i.e., glycosylated haemoglobin (HbA1C), fasting blood sugar and post prandial blood sugar. A C- peptide test will ensure to confirm that the patient is not Type 1 diabetes category but T2DM patient.Timepoint: Vist 1, Vist 2, Vist 4, Visit 6 and Visit 8	—

Secondary

Measure	Time frame
To evaluate if there is reduction in Body mass index (BMI) and any notable changes in haematology and biochemistry profile leading to improvement in quality of life.Timepoint: Vist 1, Vist 2, Vist 4, Visit 6 and Visit 8	—

Countries

India

Contacts

Public ContactMeena Dalal

Trial Guna Pvt Ltd

dr.r.n.sharma@gmail.com9740199006

Outcome results