[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Vedic Lifesciences Pvt. Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":159},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,41,65,87,112,135],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":5},"100552450","a-study-to-determine-safety-pharmakokinetics-and-efficacy-of-the-different-doses-of-vl-se-01-in-healthy-participants-100552450",false,"NCT06473246","A Study to Determine Safety, Pharmakokinetics and Efficacy of the Different Doses of VL-SE-01 in Healthy Participants.","A Randomized, Double-blind, Placebo Controlled, Parallel Study to Determine Safety, Pharmakokinetics and Efficacy of the Different Doses of VL-SE-01 in Healthy Participants.","Inclusion Criteria:\n\n* Male \\& female individuals must be 18 to 55 years of age inclusive, at the time of signing the informed consent.\n* Individuals who are healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.\n* Individual has a body weight of at least 50 kg (males) or 45 kg (females) and body mass index (BMI) within the range 18.5 to 29.9 kg\u002Fm2 (inclusive)\n* Individuals with a stressed lifestyle as assessed by PSS scores within 27- 40.\n* A male must agree to use contraception during the intervention period and for at least 7 days after the last dose of study intervention and refrain from donating sperm during this period.\n* A female is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies:\n\n  1. Not a woman of childbearing potential (WOCBP)\n  2. OR agrees to use the contraceptive during the intervention period and for at least 90 days after the last dose of study intervention\n\nExclusion Criteria:\n\n* Individual has a history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinology related, haematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention, or interfering with the interpretation of data.\n* Males who has a history of oligospermia, vasectomy and other sperm abnormalities.\n* Females who have irregularity or problems in menstrual cycles or diagnosed with polycystic ovarian syndrome.\n* Individuals with Type 1 and Type 2 Diabetes mellitus and on medication.\n* Individuals with SBP ≥ 160 mmHg and DBP ≥ 100 mmHg.\n* Individuals on anti-hypertensives.\n* History and\u002For current cases of chronic alcohol consumption or heavy drinkers as defined by:\n\n  1. For men, consuming more than 4 drinks on any day or more than 14 drinks\u002Fweek\n  2. For women, consuming more than 3 drinks on any day or more than 7 drinks\u002Fweek\n* Peri and post-menopausal women with no menstrual cycle in the last 6 months\n* Individuals with a history or actively under the influence of Hemp or CBD products by any means of administration\n* Individual has a known hypersensitivity to any components of the study medication or comparative drugs (and\u002For an investigational device) as stated in this protocol\n* Individual has a history of unexplained syncope or a family history of sudden death due to long QT syndrome\n* Individual with a history and\u002For currently diagnosed of cancer like lymphoma, leukaemia, or any malignancy.\n* Individual has past or intended use of prohibited medication or prescription medication including herbal medications within 2 weeks or 5 half-lives prior to dosing\n* Individuals have taken sleep medication within 2 weeks prior to screening\n* Individual has used hepatic enzyme-inducing drugs within 2 months prior to dosing\n* Individuals has alanine transaminase (ALT), aspartate aminotransferase (AST), or alkaline phosphatase (ALP) \\>1.5 times upper limit of normal (ULN)\n* Individual has current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones)\n* Individual has any clinically relevant electrocardiogram (ECG) finding at the Screening Visit or at Baseline\n* Individual has a history of human immunodeficiency virus (HIV), hepatitis B, and hepatitis C.",true,"ALL","18 Years","55 Years",{"count":21,"type":22},200,"ESTIMATED","INTERVENTIONAL",[25],"NA","The present study is a randomized, placebo-controlled, parallel study. 250 participants will be screened, and considering a screening failure rate of 20%, approximately 200 participants will be randomized in a ratio of 1:1:1:1:1 to receive either different doses of VL-SE-01 or placebo and will be assigned a unique randomization code. Each group will have at least 30 participants (total 150 completers) after accounting for a dropout\u002Fwithdrawal rate of 25%. The intervention duration for all the study participants is 180 days.",[28],"Healthy Population","RECRUITING","2025-12-22",{"date":32,"type":33},"2025-12-30","ACTUAL",{"date":35,"type":33},"2025-02-20",{"date":37,"type":22},"2026-02-05",{"name":39,"class":40},"Vedic Lifesciences Pvt. Ltd.","INDUSTRY",{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":48,"enrollmentInfo":49,"targetDuration":4,"studyType":23,"phases":51,"briefSummary":52,"conditions":53,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":64},"100603811","single-oral-dose-comparative-bioavailability-study-of-investigational-product-in-healthy-human-subjects-under-fasting-conditions-100603811","NCT07141368","Single Oral Dose Comparative Bioavailability Study of Investigational Product in Healthy Human Subjects Under Fasting Conditions.","An Open Label, Randomized, Balanced, Four-Treatment, Four-Sequence, Four-Period, Four-way Crossover, Single Oral Dose Comparative Bioavailability Study of Curcumin in Healthy Human Subjects Under Fasting Conditions.","Inclusion Criteria:\n\n* 9.5.1 Able and willing to participate in the study by complying with the protocol procedures as evidenced by a dated and signed informed consent form 9.5.2 Age greater than equal to 18 less than equal to 45 years. 9.5.3 Willing to consume the study product and donate blood. 9.5.4 BMI from 18.5 to 29.9 kg\u002Fm². 9.5.5 Subject with normal health as determined by personal medical and medication history, clinical examination and laboratory examinations within the clinically acceptable limits.\n\n9.5.6 Subjects having vital parameters (blood pressure, body temperature, pulse rate and respiratory rate) within acceptable limits.\n\n9.5.7 Non-smokers or mild\u002Fmoderate smokers with not more than 10 bidis\u002Fcigarettes\u002Fpipes per day, and willing to abstain from smoking or chewing any tobacco containing products at least 72.00 hours prior to check-in and throughout the sampling points.\n\n9.5.8 Agreeing not to consume food, drink and condiment containing curcumin (e.g. curry), or other curcuminoids (DMC, BDMC) for the whole duration of the study (36 hours pre-dose to 24 hours post-dose in each period).\n\n9.5.9 Good general and mental health in the opinion of the investigator: no clinically significant or relevant abnormalities upon review of medical history or following a physical examination prior to check-in.\n\n9.5.10 If study volunteer is a female and is of child bearing potential practicing an acceptable method of birth control for the duration of the study as judged by the investigator, such as condoms, foams, jellies, diaphragm, intrauterine device (IUD), or abstinence Or She is surgically sterile (had a bilateral tubal ligation, bilateral oophorectomy with or without a hysterectomy and an absence of bleeding for at least 06 months).\n\nExclusion Criteria:\n\n* 9.6.1 Any medical or surgical conditions, which might significantly interfere with the functioning of gastrointestinal tract or may affect absorption of IP and blood forming organ.\n\n9.6.2 Significant history or current evidence of malignancy or chronic - infectious, cardiovascular, renal, hepatic, ophthalmic, pulmonary, neurological, metabolic (endocrine), hematological, gastrointestinal, immunological or psychiatric disease or organ dysfunction.\n\n9.6.3 Any major illness or hospitalization within 90 days prior to first admission to the study.\n\n9.6.4 Use of any depot injection or an implant of any drug within 3 months prior to check-in and throughout the study.\n\n9.6.5 Use of any prescribed medication or OTC (including herbal drugs and vitamin supplements) within 14 days prior to check-in and throughout the study.\n\n9.6.6 Use of botanical dietary supplements during the study or within three months prior to check-in.\n\n9.6.7 Difficulty in swallowing capsules. 9.6.8 History or presence of alcohol abuse in the past one year \\[Alcohol abuse will be defined as greater than 14 drinks per week (1 drink equal to 360 mL beer, 150 mL wine, or 45 mL hard liquor)\\].\n\n9.6.9 Consumption of alcoholic products within 24.00 hours prior to check-in in each study period and throughout sampling time points.\n\n9.6.10 Positive alcohol breath or urine drug of abuse test during check-in on each study period.\n\n9.6.11 Consumption of xanthine's or its derivative containing food or beverages (e.g. chocolates, tea, coffee or cola drinks) within 48.00 hours prior to check-in and throughout sampling time points.\n\n9.6.12 Consumption of grapefruit or its juice within 72.00 hours prior to check-in in each period and throughout sampling time points.\n\n9.6.13 History of allergy or hypersensitivity intolerance to turmeric or curcumin.\n\n9.6.14 Individuals who, in the opinion of the investigator, are unlikely to be able to comply with the study.\n\n9.6.15 Irritable bowel syndrome. 9.6.16 Current disease states that are contraindicated with dietary supplementation: chronic diarrhea, constipation or abdominal pain, chronic laxatives use.\n\n9.6.17 Pathology which could affect the study results or expose the subject to an additional risk according to the investigator.\n\n9.6.18 Recent gastroenteritis or food borne illness such as confirmed food poisoning (less than 1 month).\n\n9.6.19 Blood donation within 90 Days prior to the initial visit or intending to donate within the next 90 Days.\n\n9.6.20 Low venous capital not allowing blood kinetic sampling. 9.6.21 Known or suspected food allergy, intolerance, or hypersensitivity to any of the study product ingredients and\u002For of the standard meals (gluten intolerance, celiac disease, etc.) 9.6.22 Chronic drug treatment (for example anticoagulant, antihypertensive medication, thyroid treatment, asthma treatment, anxiolytic, antidepressant, lipid-lowering treatment, corticosteroids, phlebotonic, veino-tonic, drug with impact on blood circulation) excluding oral and local contraceptives.\n\n9.6.23 Currently taking (or during the past 3 months) any botanical dietary supplement.\n\n9.6.24 History of anorexia nervosa, bulimia, or significant eating disorders according to the investigator.\n\n9.6.25 Participation in another clinical trial 90 days prior to check-in period I of this study.\n\n9.6.26 Presenting a psychological or linguistic incapability to sign the informed consent.\n\n9.6.27 Female volunteer who has used implanted or injected hormonal contraceptives anytime during the 06 months prior to check-in or used hormonal contraceptives within 14 days before check-in","45 Years",{"count":50,"type":22},24,[25],"The sponsor has developed new curcuminoid formulations with the expectation of enhanced bioavailability compared to existing benchmark products. This study aims to evaluate the comparative bioavailability and characterize the pharmacokinetic profile of the test formulations in comparison to the reference formulations in healthy adult subjects under fasting conditions.",[54],"Healthy Volunteer","NOT_YET_RECRUITING","2025-08-18",{"date":58,"type":33},"2025-08-26",{"date":60,"type":22},"2025-09-01",{"date":62,"type":22},"2025-11-01",{"name":39,"class":40},1,{"id":66,"slug":67,"hasResults":11,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":4,"eligibilityCriteria":71,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":72,"enrollmentInfo":73,"targetDuration":4,"studyType":23,"phases":75,"briefSummary":76,"conditions":77,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":5},"100595538","a-study-to-assess-the-effect-probiotic-supplement-on-immune-health-in-teachers-prone-to-upper-respiratory-tract-infection-100595538","NCT07033754","A Study to Assess the Effect Probiotic Supplement on Immune Health in Teachers Prone to Upper Respiratory Tract Infection","A Randomized, Double-blind, Placebo-controlled, Parallel Clinical Study to Assess the Effect of ProGenr8™ (Probiotic Supplement) on Immune Health in Teachers Prone to Upper Respiratory Tract Infection (URTI)","Inclusion Criteria:\n\n1. Individuals ready to give voluntary, written informed consent to participate in thestudy.\n2. Male and female teachers aged between 18 to 50 years' (both values included) withmoderate physical activity level as per International Physical Activity Questionnaire -Short Form (IPAQ - SF).\n3. Individuals with body mass index (BMI) between 22 kg per m2 to 32.0 kg per m2\n4. High susceptibility to URTIs at least once every three months for last 1 year (at least 4to 6 episodes in a year).\n5. Individuals who have active URTI episode at screening defined as \"those having a scoreof less than equal to 5 for at least 2 symptoms out of runny nose, plugged nose,sneezing, sore throat, scratchy throat, cough or head congestion on the WURSS-21\".\n6. Commitment to adhere to routine diet and physical activity.\n7. Willing to discontinue any immune-enhancing dietary supplements (e.g., prebiotics andfiber supplements, probiotics, Echinacea, fish oil, vitamin E, etc.) at least 1 one monthprior to screening.\n8. Willing to discontinue sleep medications at least 1 month prior to screening and duringthe entire study duration.\n9. Individuals willing to complete all study-related and clinical study visits as per theprotocol.\n\nExclusion Criteria:\n\n1. Individuals with a history of rhinitis medicamentosa, anatomical nasal obstruction ordeformity, nasal reconstructive surgery, etc\n2. Individuals taking prebiotics, probiotics, synbiotics or post-biotics supplements 1 monthprior to screening.\n3. Individuals with known sensitivity to the investigational products or any excipients ofthe product.\n4. Individuals with any clinically significant abnormalities of the upper respiratory tract(such as stridor, laryngomalacia, etc.).\n5. Individuals suffering from lower respiratory tract infection (LRTI) of any origin.\n6. Any individual not willing to follow the abstinence from any home-based remedies for common cold such as steam inhalation, decoctions, and vapor rub, etc.\n7. Individuals with uncontrolled type 2 diabetes as assessed by fasting blood glucose lessthan equal to 126 mg per dL.\n8. Individuals with uncontrolled hypertension on medication and with systolic bloodpressure less than 140 and or diastolic blood pressure less than equal to 90 mmHg.\n9. Individuals who are unable to abstain from herbal or dietary supplements for URTI throughout the study period.\n10. Vaccination against influenza or swine flu within 90 days prior to screening.\n11. Those who have taken or should be taking or are taking antibiotics, antivirals, steroids,nasal decongestants, antihistamines, NSAIDs, or other medications that are expected to alleviate cold symptoms within two weeks prior to screening.\n12. History of any significant neurological and psychiatric condition which may affect theparticipation and inference of the study's end points.\n13. Participation in other clinical trials in last 90 days prior to screening\n14. Individuals with substance abuse problems (within 2 years) defined as: a) Use ofrecreational drugs (such as cocaine, methamphetamine, marijuana, etc.)\u002FNicotine, tobaccoor smoking dependence. b) High-risk drinking as defined by consumption of 4 or morealcohol containing beverages on any day or 8 or more alcohol containing beverages perweek for women and 5 or more alcohol-containing beverages on any day or 15 or morealcohol containing beverages per week for men.\n15. Individuals who have clinically significant following severe illness\n16. Females who are pregnant\u002Fplanning to be pregnant or lactating or taking any oralcontraceptives.\n17. Any condition that could, in the opinion of the investigator, preclude the individual'sability to successfully and safely complete the study or that may confound studyoutcomes","50 Years",{"count":74,"type":22},100,[25],"The present study is a randomized, placebo-controlled, double-blind, parallel-group clinical studydesigned to assess the effects of IP on immune health in teachers prone to URTI. Approximately 179individuals aged between 18 and 50 years will be screened. Considering a screen failure of 20%,approximately 144 individuals will be randomized in a ratio of 1:1 to receive either the active orplacebo. The study will have at least 100 completed participants i.e. 50 participants in each studyarm after accounting for a dropout\u002Fwithdrawal rate of 30% at the end of the study. The interventionand follow-up duration for all the study participants will be 120 days.",[78],"URTI - Viral Upper Respiratory Tract Infection","2025-06-19",{"date":81,"type":33},"2025-06-24",{"date":83,"type":22},"2025-06-25",{"date":85,"type":22},"2026-01-20",{"name":39,"class":40},{"id":88,"slug":89,"hasResults":11,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":4,"eligibilityCriteria":93,"healthyVolunteers":11,"sex":94,"minAge":95,"maxAge":96,"enrollmentInfo":97,"targetDuration":4,"studyType":23,"phases":99,"briefSummary":100,"conditions":101,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":111},"100579624","a-study-to-assess-the-effect-of-libifem-vl-gf-01-on-fertility-in-women-with-diminished-ovarian-reserve-100579624","NCT06826716","A Study to Assess the Effect of Libifem® (VL-GF-01) on Fertility in Women With Diminished Ovarian Reserve","A Randomized, Double-Blind, Placebo-Controlled Clinical Study to Assess the Effect of Libifem® (VL-GF-01) on Fertility in Women With Diminished Ovarian Reserve","Inclusion Criteria:\n\n1. Individuals ready to give voluntary, written informed consent to participate in the study.\n2. Women of age between 25 to 35 years who wish to conceive.\n3. Women with BMI between 18.5 to 34.9 kg\u002Fm2 (both values included).\n4. Women who are unable to conceive for at least one year with an unprotected sexual life.\n5. Women engaging in sexual act regularly and agree to continue the same at least twice a week during the study.\n6. Women with bilateral tubal patency as confirmed by reports (within last one year from screening) of Hysterosalpingography (HSG) or Sonosalpingography (SSG).\n7. Eumenorrheic women with a regular menstrual cycle of 28 ± 5 days.\n8. Women with Hemoglobin levels greater than or equal to 10 g\u002FdL.\n9. Women with Anti-Mullerian hormone (AMH) greater than 0 and less than 1.5 ng\u002Fml on day 2 of menstrual cycle.\n10. Females with serum Thyroid-stimulating hormone (TSH) levels between 0.4 mIU\u002FL to 5 mIU\u002FL \\[both values inclusive\\] with or without medication.\n11. Women who are not pregnant during the time of screening as assessed by UPT.\n12. Women who have never undergone IVF procedure.\n13. Women with their male partners having an acceptable serum analysis report as per PI.\n14. Women willing to complete all study-related assessments and to complete all clinical study visits as per the protocol.\n\nExclusion Criteria:\n\n1. Any chronic illness like hyper-prolactinemia.\n2. Females diagnosed with stage 3 and stage 4 Endometriosis.\n3. Females with a history of recurrent pregnancy loss (defined as ≥ 2 failed clinical pregnancies before 22 weeks of gestational age).\n4. Females clinically diagnosed with Polycystic Ovarian Syndrome (PCOS).\n5. Females with a prior history (within the last 6 months from screening) of ≥3 cycles of ovulation induction.\n6. History of ovarian hyper-response.\n7. History of any endocrine abnormality (eg: Adrenal gland disorders, pituitary disorders, endocrine diseases, dyslipidemia, etc.).\n8. Females previously diagnosed with hyperparathyroidism and\u002For hyperthyroidism.\n9. Females with a history of any psychiatric disorder.\n10. Currently undergoing or have previously undergone Hormone Therapy (HT) for treatment of fertility in the previous 6 months.\n11. Currently consuming Ayurvedic\u002Fdietary supplements, and\u002For currently consuming steroids or if consumed in the last 3 months before screening.\n12. Currently consuming cytotoxics and immunosuppressants.\n13. History of uncontrolled hypertension and\u002For systolic blood pressure greater than equal to 140 mmHg and\u002For diastolic blood pressure greater than equal to 90 mmHg.\n14. Fasting blood glucose (FBG) greater than or equal to 126 mg\u002FdL.\n15. Participation in other clinical studies in the past 3 months.\n16. History of alcohol or drug abuse in the 12 months prior to screening.\n17. History of cancer.\n18. Hematological disorders.\n19. History or presence of any Sexually Transmitted Disease (STD).\n20. History of any clinically significant disease or disorder which, in the opinion of the investigator, may either put the potential individual at risk because of participation in the study, or influences the results or the potential individual's ability to participate in the study.\n21. History or presence of HIV, cardiovascular, gastrointestinal, hepatic or renal disease, or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs (i.e. Crohn's disease, short bowel, acute or chronic pancreatitis or pancreatic insufficiency).\n22. Lactating women","FEMALE","25 Years","35 Years",{"count":98,"type":22},150,[25],"The present study is a randomized, double-blind, placebo-controlled, parallel clinical study. Approximately 156 participants will be screened, and considering a screening failure rate of 20%, not more than 124 participants will be randomized in a ratio of 1:1 to receive either Libifem® or placebo and will be assigned a unique randomization code. Each group will have not less than 50 completed participants after accounting for a dropout\u002Fwithdrawal rate of 20%.",[102],"Female Fertility","2025-02-11",{"date":105,"type":33},"2025-02-14",{"date":107,"type":22},"2025-02-10",{"date":109,"type":22},"2025-12-10",{"name":39,"class":40},7,{"id":113,"slug":114,"hasResults":11,"nctId":115,"briefTitle":116,"officialTitle":117,"acronym":4,"eligibilityCriteria":118,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":119,"enrollmentInfo":120,"targetDuration":4,"studyType":23,"phases":122,"briefSummary":123,"conditions":124,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":134},"100566710","a-study-to-assess-the-effect-of-the-natural-orange-extract-in-individuals-with-gastrointestinal-discomfort-100566710","NCT06658717","A Study to Assess the Effect of the Natural Orange Extract in Individuals With Gastrointestinal Discomfort","A Randomized, Double-Blind, Two-Arm, Placebo-Controlled Clinical Study to Assess the Effect of the Natural Orange Extract in Individuals With Gastrointestinal Discomfort","Inclusion Criteria:\n\n1. Individuals willing to give written informed consent form voluntarily to participate in the study\n2. Healthy males and females of age between 18-65 years.\n3. Individuals with a Body Mass Index (BMI) between 18.5-29.9 kg\u002Fm2 (both values included).\n4. Individuals with a history of GI discomfort, associated with changes in the frequency and form of stools for the last 3 months, with symptom onset at least 6 months.\n5. Individuals with complaints of loose or watery stools, occurring in more than 25% of stools for the last 3 months.\n6. Individuals with consistent and stable body weight in the last 3 months prior to screening (less than 5% self-reported change).\n7. Individuals with a baseline score of less than or equal to 55 for the digestive domain score of the Gastrointestinal Quality of Life Index (GIQLI).\n8. Individuals with Fasting Blood Glucose (FBG) less than equal to 125 mg\u002Fdl.\n9. Individuals with systolic blood pressure (SBP) less than 140 and\u002For diastolic blood pressure (DBP) less than 90 mm Hg.\n10. Individuals willing to avoid consumption of citrus-based products during the entire study duration.\n11. Individuals willing to follow all the study procedures and follow-up visits as per protocol.\n\nExclusion Criteria:\n\n1. Individuals diagnosed with diabetes mellitus and are on active medication.\n2. Individuals diagnosed with hypertension and are on active medication.\n3. Individuals with thyroid dysfunction as assessed by Thyroid Stimulating Hormone (TSH) less than or equal to 0.4 or more than or equal to 5.0 mIU\u002FL will be excluded.\n4. Individuals with a history and\u002For presence of acute or chronic significant GI disease or digestion\u002Fabsorption disorders (e.g., Irritable bowel syndrome, inflammatory bowel disease, infectious diarrhea, coeliac disease, Clostridium difficile colitis, malabsorption, pancreatitis, disorders in digestive tract motility, gluten enteropathy, etc).\n5. Individuals with a history of autoimmune disorders.\n6. Individuals with major gastric, hepatic, biliary, pancreatic, or intestinal surgery within the last 6 months prior to screening or planned during the study (appendectomy, haemorrhoidectomy, or polypectomy allowed as long as occurred more than 3 months prior to screening; uncomplicated laparoscopic or open cholecystectomy is allowed if no history of post-operative biliary tract pain and surgery occurred more than 3 months prior to screening).\n7. Any other relevant serious organ or systemic diseases (e.g., cardiovascular, respiratory, liver, renal, neurological disease, etc).\n8. Individuals with a history of malignancy within last five years.\n9. Use of immunosuppressive drugs within 3 months prior to the screening.\n10. Use of oral corticosteroids within 1 month prior to the screening.\n11. Excessive alcohol drinking (For men, consuming five or more drinks on any day or 15 or more per week; for women, consuming four or more on any day or 8 or more drinks per week). One unit of alcohol is equal to 45 ml of hard liquor, 150 ml of wine or a pint of beer.\n12. Individuals with a history of\u002Fknown allergies to citrus fruits or citrus-based products.\n13. Individuals taking any antibiotics in the past 4 weeks and during the study.\n14. Individuals who are on regular intake of laxatives in the past 1 month prior to the screening.\n15. Individuals taking any dietary supplements, and medication for any gastrointestinal or metabolic disease (peptic ulcer, IBS, type-II diabetes, atherosclerosis, etc.)\n16. Individuals taking any hormones for any gastrointestinal or metabolic disease within 3 months prior to screening.\n17. Individuals taking any probiotics, prebiotics, post-biotics or synbiotics within 3 months prior to the screening.\n18. History of smoking or currently smoking.\n19. Individuals with gluten and\u002For lactose intolerance.\n20. Females who are pregnant\u002Flactating or planning to be pregnant.\n21. Individuals who have participated in another clinical study(ies) with an IP within 90 days before screening, or who plan to participate in another study during the study period.\n22. Any other conditions, which in the opinion of the investigator may jeopardize the study.","65 Years",{"count":121,"type":22},64,[25],"A Randomized, Double-Blind, Two-Arm, Placebo-Controlled Clinical Study to assess the Effect of the Natural Orange Extract in Individuals with Gastrointestinal Discomfort",[125],"Gut Health","2024-10-23",{"date":128,"type":33},"2024-10-26",{"date":130,"type":22},"2024-10-15",{"date":132,"type":22},"2025-01-30",{"name":39,"class":40},3,{"id":136,"slug":137,"hasResults":11,"nctId":138,"briefTitle":139,"officialTitle":140,"acronym":4,"eligibilityCriteria":141,"healthyVolunteers":16,"sex":17,"minAge":142,"maxAge":143,"enrollmentInfo":144,"targetDuration":4,"studyType":23,"phases":145,"briefSummary":146,"conditions":147,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":150,"lastUpdatePostDateStruct":151,"startDateStruct":153,"completionDateStruct":155,"leadSponsor":157,"locationsCount":158},"100554269","a-study-to-assess-effect-of-glucocil-on-metabolic-health-in-individuals-with-prediabetes-and-type-2-diabetes-mellitus-100554269","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","30 Years","70 Years",{"count":74,"type":22},[25],"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.",[148,149],"Pre Diabetes","Type2 Diabetes Mellitus","2024-07-03",{"date":152,"type":33},"2024-07-11",{"date":154,"type":22},"2024-07-25",{"date":156,"type":22},"2024-12-30",{"name":39,"class":40},5,""]