A Study to Assess Effect of Glucocil® on Metabolic Health in Individuals With Prediabetes and Type 2 Diabetes Mellitus.

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age30-70
SponsorVedic Lifesciences Pvt. Ltd.

About this trial

A randomized, double-blind, placebo-controlled study to assess the effect of Glucocil® on metabolic health in individuals with prediabetes and Type 2 Diabetes Mellitus.

Eligibility criteria

Qualifiers

Males and females of age more than equal to 30 years and less than equal to 70 years.

Body mass index within 30 kg/m2 and 35 kg/m2 (both values included) with waist circumference above 40 inches (men) or 35 inches (women).

Cohort 1 (Only for prediabetes individuals)- Individuals diagnosed with prediabetes with OGTT (140 mg/dL to 199 mg/dL); HbA1c (5.7% to 6.9%) and fasting blood glucose level (between 100 mg/dL to 125 mg/dL).

Cohort 2 (T2DM)- Individuals newly diagnosed with Type 2 diabetes mellitus with HbA1c between 7% and 9% (both values included) and fasting blood glucose level in between 126 to 180 mg/dL.

Disqualifiers

Individuals who are exclusively vegetarians diet.

Individuals with Type 1 diabetes mellitus.

Individuals with Type 2 diabetes mellitus on medication.

Individuals with any other endocrine disorder.

Trial design

Treatments tested in this trial

  • IP 1200 mg per soft gel capsule
  • Placebo Comparator: Placebo 1200 mg per soft gel capsule

Treatment groups

100 Participants
are divided into 2 treatment groups

Sponsors and collaborators