Health Condition 1: E119- Type 2 diabetes mellitus without complications
Conditions
Interventions
None listed
Sponsors
Krishnas Herbal and Ayurveda
Eligibility
Inclusion criteria
Inclusion criteria: I. Both Male and female patients aged between 18-70 years with BMI range of 18 to 40. II. Newly diagnosed or recently diagnosed (last 6 months), not taking any oral antidiabetic medications. III. Patients with HbA1c of greater than or equal to 6.5% to less than or equal to 8.9% IV. Ready to provide written informed consent form. V. No History of any known allergy with Diabic Care Juice like products or any other ingredients. VI. Willing to come for follow up visits for evaluation. VII. No significant medical/surgical disease/s at the time of screening.
Exclusion criteria
Exclusion criteria: I. Presence of any clinically significant medical or surgical condition requiring long term treatment. II. Patients who are currently using the AYUSH related medications. III. Patients already diagnosed to be suffering from the complications of Diabetes Mellitus viz., diabetic neuropathy, diabetic nephropathy, diabetic retinopathy, etc IV. Patients who have a past history of Atrial Fibrillation, Acute Coronary Syndrome, Myocardial Infarction, Stroke or Severe Arrhythmia in the last 3 months V. Patients with concurrent serious Hepatic Dysfunction defined as AST and ALT more than 3 times of the upper normal limit or Renal Dysfunction defined as S. creatinine more than 1.2mg per dl, uncontrolled or other concurrent severe disease. VI. Patients participating or participated in another clinical study within 3 months before recruitment. VII. Pregnant or Lactating women. VIII. Patient on steroids, oral contraceptive pills.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Change in Glycemic assessment (FPG and PPG) from Baseline to Week 4, Week 8 and Week 12. 2. Change in Glycated hemoglobin (HbA1c) from Baseline to Week 12. Timepoint: Baseline Day 0, Visit 2 Week 4, Visit 3 Week 8 and Visit 4 Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To assess change in Symptoms Diabetes Symptoms Questionnaire (DSQ) 2. To assess change in Lipid profile, Liver function & Renal function test values from baseline to 12th week. 3. Safety outcomes during entire observation period 3 months (Incidence of adverse events) 4. To evaluate the frequency of patients transitioning from Diabic Juice to alternative antidiabetic therapies. 5. Adverse events Data for any Adverse Event reported will be collected & recorded. Timepoint: Baseline Day 0, Visit 2 Week 4, Visit 3 Week 8 & Visit 4 Week 12 | — |
Countries
India
Contacts
Public ContactShrawan Daga
Auriga Research Pvt Ltd
Outcome results
None listed