A Clinical Study to Evaluate the effect of F-Biotic in Type 2 Diabetes Mellitus Subjects.
- Conditions
- Health Condition 1: E11- Type 2 diabetes mellitus
- Registration Number
- CTRI/2024/03/063627
- Lead Sponsor
- Arishina Life Sciences Pvt. Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mean change in Fasting blood sugar levels <br/ ><br> <br/ ><br>Timepoint: Baseline, Day 42, Day 84
- Secondary Outcome Measures
Name Time Method Mean change in biochemical parameters and biomarkersTimepoint: Baseline, Day 42, Day 84