A study to understand the effect of the Investigational Product on controlling the rise of sugar levels after the intake of common carbohyderates

Not Applicable

• Registration Number: CTRI/2014/08/004841
• Lead Sponsor: Phynova Group

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 12

Inclusion Criteria

Healthy Volunteers with a BMI between 18 and 25

Non-Diabetic or any pre-diabetic conditions demonstrated by a fasting blood sugar between 3.9 to 5.5 mmols/L (70 - 100mg/dL).Not on any diabetic or insulin resistance medication

Exclusion Criteria

Abnormal laboratory values at screening.

Pregnant or Lactating women

Subjects with any cardio-vascular diseases

Subjects otherwise judged by the PI not fit to participate in the study

Any past significant medical history

Any Psychiatric disorder or on any such medications

Any malignancy or history of malignancies

Any known hypersensitivity or allergy

Recent participation (within the last 3 months) in any other clinical trial

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess the effect of IP on the Glycaemic Index of common carbohydratesTimepoint: Blood samples will be taken during -15mins, 0mins, 15mins, 30mins, 45mins, 60mins, 90mins and 120mins during each visit

Secondary Outcome Measures

Name	Time	Method
To assess the safety of the IPTimepoint: Any AEs and SAEs to be recorded, reported and followed up during the time of the participation in the study.