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ClinicalTrials.gov ID

NCT06496893

Lead Sponsor

Vedic Lifesciences Pvt. Ltd.INDUSTRY

Overall Status

Unknown status

Study Type

Interventional

Phase

Not Applicable

Enrollment

100Estimated

Last Update Posted

Jul 11, 2024Actual

Start Date

Jul 25, 2024Estimated

Primary Completion Date

Dec 25, 2024Estimated

Completion Date

Dec 30, 2024Estimated

Official Title

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.

Brief 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

• Pre Diabetes
• Type2 Diabetes Mellitus

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

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

Yes

Eligibility Criteria

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.
11. History of malignancy or stroke.
12. Chronic alcoholism: History and/or current cases of chronic alcohol consumption or heavy drinkers as defined by i.For men consuming more than 4 drinks on any day or more than 14 drinks/week ii. For women, consuming more than 3 drinks on any day or more than 7 drinks/week
13. Individuals taking concomitant medication known to alter blood sugar.
14. Individuals having treatment with herbal or any other supplements.
15. Any condition or abnormality that would compromise the safety of the individuals or the quality of the study data.
16. Use of another investigational product within 3 months of the screening visit.
17. Females who are lactating, pregnant or planning to be pregnant or taking any oral contraceptives

Primary Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

Quadruple

Lead Sponsor

Vedic Lifesciences Pvt. Ltd.INDUSTRY

drgovind.rankawat@gmail.com7891368525

drgauravsingh371@gmail.com9555112643

dilipchaurasiya250@gmail.com7292022991