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

NOT_YET_RECRUITINGNA

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

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.

NCT06496893•Vedic Lifesciences Pvt. Ltd.

View on ClinicalTrials.gov

Summary

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.

Detailed Description

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

Age

30 - 70 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. Males and females of age more than equal to 30 years and less than equal to 70 years.
•2. 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).
•3. 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).
•4. 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.
•5. Triglycerides between 150 mg/dL and 299 mg/dL (both values inclusive) and/or Low-Density Lipoprotein (LDL) in between 130 mg/dL and 189 mg/dL (both values inclusive).
•6. Individuals having non-vegetarian diet for at least 2 days a week.
•7. Non-smoker.
•8. Individuals who are willing to not change their physical activity levels throughout the study period.
•9. Individuals willing to complete all study-related questionnaires and to complete all clinical study visits.
•10. Individuals ready to give voluntary, written informed consent to participate in the study.

Exclusion Criteria

•1. Individuals who are exclusively vegetarians diet.
•2. Individuals with Type 1 diabetes mellitus.
•3. Individuals with Type 2 diabetes mellitus on medication.
•4. Individuals with any other endocrine disorder.
•5. Individuals who are currently on diuretics or thyroid supplements
•6. Individuals on lipid-lowering therapies.
•7. Individuals with uncontrolled hypertenstion as assessed by systolic over diastolic blood pressure (≥ 140/90 mmHg).
•8. Individuals who are currently on antihypertensive medication.
•9. Individuals with cardiac arrhythmia, impaired hepatic or renal function
•10. Individuals having heart failure, coronary artery disease, hyperthyroidism, hypothyroidism, cancer or mental disease or any other serious disease requiring active treatment.
+7 more criteria

Locations (5)

Shourya clinic

Pune, Maharashta, India

Shri balaji Multispeciality hospital,

Thane, Maharashtra, India

Dr.Govinds Clinic,

Jaipur, Rajashthan, India

Upendra Medicare

Varanasi, Uttar Pradesh, India

Arihant Hospital

Varanasi, Uttar Pradesh, India

Key Dates

Start Date

July 25, 2024

Primary Completion Date

December 25, 2024

Completion Date

December 30, 2024

Last Updated

July 11, 2024

Enrollment

100

ESTIMATED participants

Conditions

Pre DiabetesType2 Diabetes Mellitus

Interventions

IP 1200 mg per soft gel capsule

DIETARY_SUPPLEMENT

Placebo Comparator: Placebo 1200 mg per soft gel capsule

DIETARY_SUPPLEMENT

Contacts

Dr. Shalini Srivastava,, MBBS, MD

CONTACT

7738418890 shalini.s@vediclifesciences.com

Lalit Pawaskar, M.Pharm, PGDM

CONTACT

7738418890 lalit.p@vediclifesciences.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 11, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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