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

An Open Label, Single Center Study to assess the effect of IminoNorm on the Glycaemic index of common carbohydrates

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2014/08/004841
Enrollment
12
Registered
2014-08-07
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: IminoNorm: 0.25mg of IminoNorm powder,once a day when the volunteer is at the site on visit 4,5,6 and 7 to be taken orally along with 200ml of water Control Intervention1: Glucose: 50gm

Sponsors

Phynova Group
Lead Sponsor

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

India

Contacts

Public ContactDrRohit Kulkarni

Pulse Diagnostic Centre

info@tcrs.in

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026