Health Condition 1: E11- Type 2 diabetes mellitus
Conditions
Interventions
Intervention1: F-Biotic™: Oral Administration of a Single sachet of F-Biotic™ once a day for 12 weeks
Control Intervention1: Placebo: Oral Administration of a single sachet of placebo once a day for
Sponsors
Arishina Life Sciences Pvt. Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subjects diagnosed with Type 2 diabetes mellitus on stable metformin monotherapy for 8 weeks prior to the screening with: o Glycated hemoglobin (HbA1c) between greater than or equal to 6.6 and less than or equal to 9% o Fasting blood sugar greater than or equal to 126 mg per dl o BMI of 23-32 kg per meter square 2. Females of childbearing age, agree to use approved birth control methods during the study, and have negative urine pregnancy test at screening. 3. Subject willing to adhere with their routine diet, physical activity, and general lifestyle throughout the study. 4. Must be willing and able to give informed consent and comply with the study procedures.
Exclusion criteria
Exclusion criteria: 1. Subjects diagnosed with Type 1 diabetes mellitus 2. Subjects currently on any medications or supplements other than metformin known to influence blood glucose concentration 3. Subjects with following levels at Screening visit o Fasting blood triglycerides greather than 400 mg per dL o Low density lipoprotein (LDL) greater than 190 mg per dL o HbA1c greater than 9% 4. Subjects with history of o Uncontrolled or serious medical illness including renal, liver disease, hypertension. o Diabetes ketoacidosis o Cardiac disease or neurological problems o Auto-immune disease (rheumatoid arthritis, lupus, type 1 diabetes) o Gastrointestinal tract bleeding or peptic ulcer disease o Psychiatric disorders or Severe neurological diseases or seizures 5. Subjects who maybe allergic to any of the natural constituents of the Investigational Product 6. Known HIV or Hepatitis B positive or any other immuno-compromised state 7. Pregnant and lactating women 8. Currently participating or having participated in another clinical trial during the last 3 months prior to the beginning of this study 9. Any additional condition(s) that in the Investigators opinion that may interfere with subject treatment, assessment or compliance with the protocol and would warrant exclusion from the study or prevent the subject from completing the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change in Fasting blood sugar levels Timepoint: Baseline, Day 42, Day 84 | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean change in biochemical parameters and biomarkersTimepoint: Baseline, Day 42, Day 84 | — |
Countries
India
Contacts
Public ContactJestin V Thomas
Leads Clinical Research and Bio Services Pvt. Ltd
Outcome results
None listed