Health Condition 1: E119- Type 2 diabetes mellitus without complications
Conditions
Interventions
Intervention1: Active arm 2: Dose: 5gm / 10gm
Frequency: Once in a day
Route of administration: Oral
Duration: Approximately 45 days
Intervention2: Active arm 1: Dose: 5gm / 10gm
Frequency: Once in
Sponsors
Biogen extracts pvt ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Male and female aged more than or equal to 18 and less than or equal to 65 years of age 2.Subjects with BMI more than or equal to 18 to less than or equal to 29.9 kg/m2 3.Females of child-bearing age should be willing to use standard methods of contraception 4.Must be willing to give written informed consent and comply with the study procedures.
Exclusion criteria
Exclusion criteria: 1. Subjects with diabetes mellitus with HbA1c more than or equal to 7.5 2. Subject with any uncontrolled medical condition and/or unstable medical illness 3. Subjects with gastrointestinal disorders (e.g., chronic diarrhea, gastro-intestinal diseases, irritable bowel syndrome) 4. History of abuse and or addiction to drugs, any substance, cigarette smoking and alcohol. 5. Subjects consuming herbal fenugreek products or herbal supplements for the duration of study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in appetite scores in 5g and 10g vs the control arm.Timepoint: Day 15, Day 30 and Day 45 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change in body weight and BMI in 5g and 10g vs the control arm 2. Changes in blood glucose levels (FBS and 2hrPPBS) in 5g and 10g vs the control arm 3. Serum insulin response in 5g and 10g vs the control arm 4. Change in organoleptic properties score in 5g and 10g 5. Incidence rates of adverse events in 5g and 10gTimepoint: Day 15, Day 30 and Day 45 | — |
Countries
India
Contacts
Public ContactVijay Bhaskar T
NextBio Research Pvt Ltd
Outcome results
None listed