A Randomized, Open labelled, Active-controlled, Prospective Clinical Study to Evaluate Efficacy and Safety of Diabic Care Juice in Type 2 Diabetic Patients

Patients diagnosed with Type 2 Diabetes Mellitus for not more than one year and not exposed to any OHA drugs, attending outpatient clinic of study site will be screened for eligibility criteria. On screening visit, a written informed consent will be obtained from patients for their participation in the study. Patient’s history will be recorded and his/her physical examination will be done. Then patient’s fasting and postprandial blood sugar tests will be done. If HbA1c value will be between 6.5 and 8% (both inclusive) and random blood sugar level not above 200 mg/dl, then they will be advised to undergo ECG. If the ECG does not demonstrate any signs of uncontrolled arrhythmia / acute ischemia, then patient will be advised to undergo investigations i.e., CBC, ESR, Fasting Serum Insulin, Liver function tests, Renal function tests, Lipid profile, Urine routine and microscopic examinations and HIV test. Urine pregnancy test will be advised only if the patient is female of child bearing potential. Patient’s body weight, BMI, waist circumference, hip circumference and waist/hip ratio will be measured.

If patient is taking any other medication for Diabetes Mellitus, he/she will be given a out period of 7 days (screening visit to baseline visit) during which he/she will be asked to stop them.On baseline visit, patients will be recruited in the study if he/she will meet all the inclusion/exclusion criteria. Patients will be then randomized to one of the two study groups as per the computer-generated randomization list. Patient’s general and systemic examinations will be done. Patient’s clinical symptoms of Type 2 DM will be assessed. Patient’s quality of life will be evaluated on WHO-QOL-BREF Questionnaire. Patient’s HOMA-IR score will be calculated on following formula.

[Fasting Glucose (mg/dl) X fasting insulin /405].

Patient’s body weight, BMI, waist circumference, hip circumference, waist/hip ratio, will be measured.

On baseline visit and at every follow up visit (except last follow up visit),

Diabic Care Juice bottles will be dispensed to patients in Group A. They will be instructed to consume it in a dose of 30 ml along with 30 ml water twice daily, empty stomach in morning and thirty minutes post-dinner. Patients in the group B will be prescribed tab. Metformin 500 – 1000 mg twice a day. On visit 1 (day 15), visit 2 (day 30), visit 3 (day 45), visit 4 (day 60), visit 5 (day 75), follow up with fasting and PP BSL estimation will be done for dose adjustment of OHAs in group B and requirement of OHAs as rescue medications in group A.

Drug compliance will be assessed by the investigator on every follow up visit. Patients will be advised to follow the diet and exercise regimen during the entire study. Patients will be called for follow up visits on every 15th day till 90 days after the baseline visit. On every follow up visit, patient’s general and systemic examinations and assessment of clinical symptoms of Type 2 DM will be done. Patient’s quality of life will be evaluated on WHO-QOL-BREF Questionnaire on monthly basis. Patient’s blood sugar (Fasting and Postprandial) will be checked every 15 days. Patient’s weight, BMI, waist circumference, hip circumference, waist /hip ratio will be measured.

At the end of study, patient’s HOMA-IR score will be estimated using the formula. Tolerability of the study drugs will be assessed by the investigator and by patient during the study period and at the end of the study. All the patients will be closely monitored for any Adverse Events starting from baseline visit till the end of the study visit. On final follow up visit (i.e., Day 90), patient’s laboratory investigations viz. CBC, ESR, BSL (fasting & Postprandial), Fasting Serum Insulin, HbA1c%, Liver function tests, Renal function tests, Lipid profile and Urine routine & microscopic will be performed. ECG will also be done at the end of the study. After completion of 90 days of study period, all the patients will be asked to stop study medication and take advice of investigator for further treatment.