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Ltd.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Active 1200 mg per soft gel capsule","ACTIVE_COMPARATOR","Combination of Vitamin B1, B6, B12, D3, Chromium Picolinate, Proprietary Mulberry Leaf Extract, Cinnamon Bark Powder, Gymnema Sylvestre Extract, Insulina (Cissus Sicyoides) Leaf Extract, Alpha Lipoic Acid, Phellodendron Bark Extract (Berberine HCL), Cissus Quadrangularis Extract, Banaba Leaf Extract, \\& Fish Oil.\n\nTwo soft gels to be taken with breakfast and two soft gels to be taken with dinner",[13],"Dietary Supplement: IP 1200 mg per soft gel capsule",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo (Soyabean oil) 1200 mg per soft gel capsule","PLACEBO_COMPARATOR","Two soft gels to be taken with breakfast and two soft gels to be taken with dinner",[19],"Dietary Supplement: Placebo Comparator: Placebo 1200 mg per soft gel capsule",[21,26],{"type":22,"name":23,"description":17,"armGroupLabels":24,"otherNames":25},"DIETARY_SUPPLEMENT","IP 1200 mg per soft gel capsule",[9],null,{"type":22,"name":27,"description":17,"armGroupLabels":28,"otherNames":25},"Placebo Comparator: Placebo 1200 mg per soft gel capsule",[15],[30,35],{"name":31,"role":32,"phone":33,"phoneExt":25,"email":34},"Dr. Shalini Srivastava,, MBBS, MD","CONTACT","7738418890","shalini.s@vediclifesciences.com",{"name":36,"role":32,"phone":33,"phoneExt":25,"email":37},"Lalit Pawaskar, M.Pharm, PGDM","lalit.p@vediclifesciences.com",[39,56,71,86,101],{"facility":40,"status":25,"city":41,"state":42,"zip":25,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"Shourya clinic","Pune","Maharashta","India","IN",{"type":46,"coordinates":47},"Point",[48,49],73.85535,18.51957,{"lat":49,"lon":48},[52],{"name":53,"role":32,"phone":54,"phoneExt":25,"email":55},"Dr. Nikhil More, MBBS MD","8446512457","nikhilmore8750@gmail.com",{"facility":57,"status":25,"city":58,"state":59,"zip":60,"country":43,"countryCode":44,"cosmosGeoPoint":61,"geoPoint":65,"contacts":66},"Shri balaji Multispeciality hospital,","Thane","Maharashtra","421503",{"type":46,"coordinates":62},[63,64],72.96355,19.19704,{"lat":64,"lon":63},[67],{"name":68,"role":32,"phone":69,"phoneExt":25,"email":70},"Dr. Hemant Ingole, MBBS, MD","8600848920","hemantingole11@gmail.com",{"facility":72,"status":25,"city":73,"state":74,"zip":75,"country":43,"countryCode":44,"cosmosGeoPoint":76,"geoPoint":80,"contacts":81},"Dr.Govinds Clinic,","Jaipur","Rajashthan","302033",{"type":46,"coordinates":77},[78,79],75.78781,26.91962,{"lat":79,"lon":78},[82],{"name":83,"role":32,"phone":84,"phoneExt":25,"email":85},"Dr Govid Rankawat, MBBS MD","7891368525","drgovind.rankawat@gmail.com",{"facility":87,"status":25,"city":88,"state":89,"zip":90,"country":43,"countryCode":44,"cosmosGeoPoint":91,"geoPoint":95,"contacts":96},"Upendra Medicare","Varanasi","Uttar Pradesh","221001",{"type":46,"coordinates":92},[93,94],83.01041,25.31668,{"lat":94,"lon":93},[97],{"name":98,"role":32,"phone":99,"phoneExt":25,"email":100},"Dr. Gaurav Singh, MBBS MD","9555112643","drgauravsingh371@gmail.com",{"facility":102,"status":25,"city":88,"state":89,"zip":103,"country":43,"countryCode":44,"cosmosGeoPoint":104,"geoPoint":106,"contacts":107},"Arihant Hospital","221011",{"type":46,"coordinates":105},[93,94],{"lat":94,"lon":93},[108],{"name":109,"role":32,"phone":110,"phoneExt":25,"email":111},"Dr. Dilip Chaurasiya, MBBS,MD","7292022991","dilipchaurasiya250@gmail.com",{"type":113,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100554269","a-study-to-assess-effect-of-glucocil-on-metabolic-health-in-individuals-with-prediabetes-and-type-2-diabetes-mellitus-100554269",false,"NCT06496893","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.","Inclusion Criteria:\n\n1. Males and females of age more than equal to 30 years and less than equal to 70 years.\n2. Body mass index within 30 kg\u002Fm2 and 35 kg\u002Fm2 (both values included) with waist circumference above 40 inches (men) or 35 inches (women).\n3. Cohort 1 (Only for prediabetes individuals)- Individuals diagnosed with prediabetes with OGTT (140 mg\u002FdL to 199 mg\u002FdL); HbA1c (5.7% to 6.9%) and fasting blood glucose level (between 100 mg\u002FdL to 125 mg\u002FdL).\n4. 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\u002FdL.\n5. Triglycerides between 150 mg\u002FdL and 299 mg\u002FdL (both values inclusive) and\u002For Low-Density Lipoprotein (LDL) in between 130 mg\u002FdL and 189 mg\u002FdL (both values inclusive).\n6. Individuals having non-vegetarian diet for at least 2 days a week.\n7. Non-smoker.\n8. Individuals who are willing to not change their physical activity levels throughout the study period.\n9. Individuals willing to complete all study-related questionnaires and to complete all clinical study visits.\n10. Individuals ready to give voluntary, written informed consent to participate in the study.\n\nExclusion Criteria:\n\n1. Individuals who are exclusively vegetarians diet.\n2. Individuals with Type 1 diabetes mellitus.\n3. Individuals with Type 2 diabetes mellitus on medication.\n4. Individuals with any other endocrine disorder.\n5. Individuals who are currently on diuretics or thyroid supplements\n6. Individuals on lipid-lowering therapies.\n7. Individuals with uncontrolled hypertenstion as assessed by systolic over diastolic blood pressure (≥ 140\u002F90 mmHg).\n8. Individuals who are currently on antihypertensive medication.\n9. Individuals with cardiac arrhythmia, impaired hepatic or renal function\n10. Individuals having heart failure, coronary artery disease, hyperthyroidism, hypothyroidism, cancer or mental disease or any other serious disease requiring active treatment.\n11. History of malignancy or stroke.\n12. Chronic alcoholism: History and\u002For 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\u002Fweek ii. For women, consuming more than 3 drinks on any day or more than 7 drinks\u002Fweek\n13. Individuals taking concomitant medication known to alter blood sugar.\n14. Individuals having treatment with herbal or any other supplements.\n15. Any condition or abnormality that would compromise the safety of the individuals or the quality of the study data.\n16. Use of another investigational product within 3 months of the screening visit.\n17. Females who are lactating, pregnant or planning to be pregnant or taking any oral contraceptives",true,"ALL","30 Years","70 Years",{"count":126,"type":127},100,"ESTIMATED","INTERVENTIONAL",[130],"NA","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.",[133,134],"Pre Diabetes","Type2 Diabetes Mellitus","NOT_YET_RECRUITING","2024-07-03",{"date":138,"type":139},"2024-07-11","ACTUAL",{"date":141,"type":127},"2024-07-25",{"date":143,"type":127},"2024-12-30",{"name":5,"class":6},5]