Health Condition 1: null- Diabetes mellitus (Type 1 and Type 2) Health Condition 2: E11- Type 2 diabetes mellitus
Conditions
Interventions
Intervention1: SUCCARE: Two tea spoons-Empty stomach at morning
One Tea Spoon -Before lunch and dinner
One Tea Spoon- 05 Grams for 90 days
Control Intervention1: Nil: Nil
Sponsors
Natural Solutions
Eligibility
Inclusion criteria
Inclusion criteria: Aged 30 to 65 years Male and female patients with diabetes mellitus with/without CKD. Patients with inadequate glucose control on/not on any anti diabetic drugs Body mass index between 20-35 kg/m2 In case of CKD patients as per PI discretion: I. eGFR= 70 ml/min II. Presence of protein and Blood in the Urine Having fasting blood glucose > 126 mg/dL Post prandial blood glucose > 200 mg/dL Having no serious physical or biochemical abnormalities other than those generally associated with diabetes mellitus (Type 1 and Type 2) Patient is willing and able to comply with all trial requirements Ability to understand the Informed Consent and Willing to Sign on informed consent accordance with GCP and local legislation. Patients able to understand and follow the protocol of the trial. Participants who are able to visit the medical institutions throughout the study period.
Exclusion criteria
Exclusion criteria: Patients having diabetes other than Insulin dependent & non insulin dependent diabetes mellitus. Having history of hypersensitivity, liver or kidney damage or gastrointestinal disorders, acute infections, diseases of blood or hematopoietic organs Pregnant or lactating women and patients receiving any concomitant medication, which may have interacted with hypoglycemic action of study drug. Subjects who are already taking or have taken in the past 2 months any investigational drug Lack of suitability for participation in the trial, for any reason, as judged by PI History of HIV/HBS/HCV positive serology
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcomes: Reduction in plasma glucose levels (fasting and post prandial glucose) Reduction in HbA1c level (glycosylated hemoglobin) as compared with Screening Improvement in Lifestyle Questionnaire Scores compared to Baseline.Timepoint: Baseline to End of the treatment (Day 90) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes: Incidence of any related adverse effects Vital signs and physical examinations (pulse rate, blood pressure, weight) Selected biochemistry and hematology parameters at screening and after treatmentTimepoint: Baseline to end of the treatment (Day 90) | — |
Countries
India
Contacts
Public ContactDr Harisha S
ICBio Clinical research Pvt Ltd
Outcome results
None listed