Health Condition 1: null- Pre Diabetic Subjects
Conditions
Interventions
Intervention1: Nutricharge Glycem Tablet administered with Nutricharge Glycem Prodiet: Nutraceutical Product
Control Intervention1: NA: NA
Sponsors
Trophic Wellness Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1)Willing and able to understand and provide written informed consent. 2) Male or Female aged 18 years and older 3) Random blood glucose level between 140 to 200mg/dL 4) Eligible participants must not be diagnosed with Type 1 or Type 2 diabetes 5) Being mentally competent and able to understand all study requirements. 6) General medical condition does not interfere with trial procedures (at investigator discretion) 7) Females are eligible if: A. They do not plan to become pregnant during the study B. Negative screening pregnancy test C. Sexually active women, unless surgically sterile or post menopausal, must use one of the following methods to avoid pregnancy during the study: 1. Abstinence from penile/vaginal intercourse during the study; 2. Double barrier contraceptive methods 1 of which must be condom.
Exclusion criteria
Exclusion criteria: 1. Known hypersensitivity to the Investigational Product 2. Lactose intolerance 3. Unable to perform low impact physical activity, such as being chair-bound or having low mobility; 4. Being unable to chew and digest food normally and to eat a balanced diet (e.g. any digestive disease) 5. Type 1 and Type 2 Diabetic patients 6. Subjects taking Hypoglycaemic medication/s 7. Subjects positive for hepatitis B, Hepatitis C, HIV 1 & 2, VDRL or active autoimmune disorders. 8. In subjects with hepatic impairment. Having clinically significant ALT. AST bilirubin levels at screening. 9. Serious underlying diseases or disorder and complications that may interfere for assessment of the efficacy and safety of the Investigational Productas perthe discretion of the Investigator. 10. Any clinically significant abnormal laboratory parameter evaluated duringscreening. 11. Current use of nutritional supplements and or medical foods within 30 daysprior to the beginning of the study and for the duration of the study. 12. Use of prescription medications and/or nonprescription medications for acutemedical conditions, semi-acute medical conditions and weight loss. 13. Female subjects who are currently pregnant and/or breast feeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome measure is to assess the change in Random Blood glucose level from baseline to day 90 in pre-diabetic subjects.Timepoint: Day 90 | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary outcome measures are 1. To monitor Adverse Events/Serious Adverse Events (SAE) (including laboratory variables) occurrence 2. Stark QOL (Overall health status)assessment on day 30, 60 and 90 Timepoint: Day 90 | — |
Countries
India
Contacts
Public ContactDr Sandeep Singh
CBCC Global Research LLP
Outcome results
None listed