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Open label study for Evaluation of glycemic index (GI) of Diabliss Herbal Sugar for food classification per ISO 26642 test procedure among healthy subjects

A prospective single centric, open label study for Evaluation of glycemic index (GI) of Diabliss Herbal Sugar (Diabliss Sugar consists of cane sugar fortified with herbal extracts) for food classification per ISO 26642 test procedure among healthy subjects - NILL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/07/070733
Enrollment
15
Registered
2024-07-16
Start date
Unknown
Completion date
Unknown
Last updated
2024-08-19

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

Conditions

None listed

Interventions

Control Intervention1: DIABLISS HERBAL SUGAR: DIABLISS SUGAR CONSISTS OF CANE SUGAR FORTIFIED WITH HERBAL EXTRACTS Dose:50 g diabliss herbal sugar in 200 ml water Route: Oral Frequancy: OD before f

Sponsors

Diabliss Consumer Products Pvt Limited
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Subjects will be enrolled if they satisfy following Inclusion and exclusion criteria. Age 21 to 60years male and female Inclusion criteria: Selection of a minimum of 10 healthy subjects shall be made on the basis of: 1. No known food allergy or intolerance; 2. No medications known to affect glucose tolerance (excluding oral contraceptives) — stable doses of oral contraceptives, acetylsalicylic acid, thyroxin, vitamins and mineral supplements or drugs to treat hypertension or osteoporosis are acceptable

Exclusion criteria

Exclusion criteria: Exclusion Criteria: 1. No known history of diabetes mellitus or the use of antihyperglycaemic drugs or insulin to treat diabetes and related conditions; 2. a major medical or surgical event requiring hospitalization within the preceding 3 months; 3. the presence of disease or drug(s) which influence digestion and absorption of nutrients; 4. the use of steroids, protease inhibitors or antipsychotics (all of which have major effects on glucose metabolism and body fat distribution).

Design outcomes

Primary

MeasureTime frame
Primary endpoint: 1.Completion of the GI test per ISO 26642 test procedure Timepoint: one week or 7 days

Secondary

MeasureTime frame
Secondary endpoints: – Safety will be assessed from the number of adverse events occurred & judging their causal relationship to the study Diabliss Herbal Sugar. Timepoint: one week or 7 days

Countries

India

Contacts

Public ContactKalluri Vihari

BANU HOSPITAL A UNIT OF PCRI HOSPITALS PVT LTD

gayazuddin@pcripl.com8096368108

Outcome results

None listed

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