NCT06496893Completed
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.
Source: ClinicalTrials.gov · Last updated 5 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 104 (actual)
- First submitted
- 3 Jul 2024
- Start date
- 12 Sept 2024
- Primary completion date
- 26 Mar 2025
- Lead sponsor
- Vedic Lifesciences Pvt. Ltd.
- Diseases
- Type 2 diabetes
- NCT number
- NCT06496893
What you commit to
- Study type: Interventional
- Participants enrolled: 104
- From 12 Sept 2024 to the primary completion date, 26 Mar 2025
- 6 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Individuals who are currently on diuretics or thyroid supplements
- Individuals on lipid-lowering therapies.
- Individuals who are currently on antihypertensive medication.
- Individuals taking concomitant medication known to alter blood sugar.
- Individuals having treatment with herbal or any other supplements.
- Use of another investigational product within 3 months of the screening visit.
Other illness
- Individuals with Type 1 diabetes mellitus.
- Individuals with Type 2 diabetes mellitus on medication.
- Individuals with any other endocrine disorder.
- Individuals with cardiac arrhythmia, impaired hepatic or renal function
- Individuals having heart failure, coronary artery disease, hyperthyroidism, hypothyroidism, cancer or mental disease or any other serious disease requiring active treatment.
- History of malignancy or stroke.
- Any condition or abnormality that would compromise the safety of the individuals or the quality of the study data.
Other
- Individuals who are exclusively vegetarians diet.
- Individuals with uncontrolled hypertenstion as assessed by systolic over diastolic blood pressure (≥ 140/90 mmHg).
- 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
- Females who are lactating, pregnant or planning to be pregnant or taking any oral contraceptives
Who the study is looking for
- 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.
- 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).
- Individuals having non-vegetarian diet for at least 2 days a week.
- Non-smoker.
- Individuals who are willing to not change their physical activity levels throughout the study period.
- Individuals willing to complete all study-related questionnaires and to complete all clinical study visits.
- Individuals ready to give voluntary, written informed consent to participate in the study.
Age in the registry: 30 years to 70 years · Sex: All · Accepts healthy volunteers
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Dr.Govinds Clinic, Coordinator of this site? Confirm its status | Jaipur | India | Unknown status |
| Punawale Multispeciality Hospital Coordinator of this site? Confirm its status | Pune | India | Unknown status |
| Shourya clinic Coordinator of this site? Confirm its status | Pune | India | Unknown status |
| Shri balaji Multispeciality hospital, Coordinator of this site? Confirm its status | Thane | India | Unknown status |
| Arihant Hospital Coordinator of this site? Confirm its status | Varanasi | India | Unknown status |
| Upendra Medicare Coordinator of this site? Confirm its status | Varanasi | India | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.