Ignite Creation Date:
2025-12-25 @ 3:44 AM
Ignite Modification Date:
2025-12-26 @ 2:30 AM
Study NCT ID:
NCT06645002
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-10-16
First Post:
2024-09-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Stevia Leave Powder on Blood Glucose and Lipid Profile of Diabetic Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 144}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2024-08-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2025-02-22', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-15', 'studyFirstSubmitDate': '2024-09-27', 'studyFirstSubmitQcDate': '2024-10-15', 'lastUpdatePostDateStruct': {'date': '2024-10-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-22', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To compare the effects of short and long-term treatment of stevia powder capsules on blood glucose levels among diabetic patients', 'timeFrame': 'Short term study (7 days) long term study (60 days)', 'description': 'Teatment group respondents of short term study will be received the stevia powder capsules of 1000mg for 7 days, this group includes the initial screening and assessment of subjects suffering from type-II diabetes. The subjects will also being studied for medical history and anthropometric parameters which include height and weight, BMI and biochemical parameters which include blood glucose levels of fasting, post-prandial, insulin resistance and HbA1c In addition, a dietary study will also be done by food diary method on 3 alternative days. The biochemical parameters of the subjects will be measured at 0, 7th and at 60th day.\n\nLong-term treatment group participants will receive the treatment with 1000mg stevia powder in capsulated form once per day for 60 days, this group will also undergo the initial screening and assessment of anthropometric and biochemical parameters at 0, 30th and 60th day then will perform comparison analysis at 60th day for both short and long-term studies.'}], 'secondaryOutcomes': [{'measure': 'To compare the effects of short and long-term treatment of stevia powder capsules on lipid profile and LFTs among diabetic patients', 'timeFrame': 'Short term study (7 days) long term study (60 days)', 'description': 'Treatment group respondents of short term study will be received the stevia powder capsules of 1000mg for 7 days, After initial assessment, BMI and blood glucose levels record, the lipid profile including, cholesterol, HDL, LDL and LFTs including ALT, AST will also be measured 0, 7th and at 60th day. Same tests will also be performed on long-term study participants and will measure the results at 0, 30 and 60th day of the study, then will perform comparison analysis at 60th day for both short and long-term studies.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Diabetes', 'Stevia', 'Glucose', 'Lipid profile'], 'conditions': ['Diabetes']}, 'referencesModule': {'references': [{'pmid': '26781312', 'type': 'BACKGROUND', 'citation': 'Ritu M, Nandini J. Nutritional composition of Stevia rebaudiana, a sweet herb, and its hypoglycaemic and hypolipidaemic effect on patients with non-insulin dependent diabetes mellitus. J Sci Food Agric. 2016 Sep;96(12):4231-4. doi: 10.1002/jsfa.7627. Epub 2016 Feb 22.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to know if stevia leave powder capsule (1000 mg/day) will work to treat diabetes in participants. The main objectives it aims to answer are:\n\nDoes stevia decrease the blood glucose level in diabetic subjects that will use stevia powder capsule? Does stevia play its role in blood lipid profile in diabetic subjects that will use stevia powder capsule? The purpose of the study to see the impact of stevia in short (7 days) and long-term treatments (60 days) in diabetic subjects and compare the results\n\nDiabetic subjects will:\n\nTake stevia powder capsule every day for 7 days in short term study Take stevia powder capsule every day for 60 days in long term study\n\nCheck the biochemical assessment including blood glucose and lipid profile tests at 0 and 7th days in short term study Check the biochemical assessment including blood glucose and lipid profile tests at 0 and 30 and 60th days in long term study Keep a record of all the tests for comparison', 'detailedDescription': 'The selected participants will be randomly divided into placebo and treatment groups. The Initial (0-Day) data on anthropometric measurements and blood analysis on glucose, lipid levels and liver function tests (LFTs) will be carried out.\n\nThe balance diet plan will be prepared according to Pakistan dietary guidelines and given to all the study participants. Treatment stevia powder capsules will be provided to the participants for 7 days and for 60 days for short and long-term study respectively, for monitoring of compliance. Anthropometric measurements and biochemical assessments like blood glucose levels, lipid profile, insulin resistance and LFTs for short-term study will be measured at baseline, 7th and 60th day while, measurements of blood glucose, lipid profile, insulin resistance and LFTs will be carried out a baseline, 30, and 60 days for long-term study. In this research we will be analysed the effect of stevia powder capsules on diabetic patients for short and long term study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '25 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nInclusion Criteria: Individuals with the following conditions will be included as participants;\n\n* Patients of type 2 diabetes mellitus with the age range between 25-35 years from both genders\n* Diabetic patients without anti-diabetic drugs and their duration of diabetes no longer than 6 months\n* Diabetic patients with HbA1c \\>6% and blood sugar level \\>200 mg/dL\n\nExclusion Criteria:\n\nIndividuals with the following conditions were not included as participants;\n\n* Patients with nephropathy, retinopathy, diabetic foot, phenylketonuria, maple syrup urine disease\n* Participants with acute and chronic kidney disease, kidney stone,\n* Participants with history of acute liver injury (e.g., hepatitis) or severe cirrhosis\n* Diabetic patients with obesity, cardiovascular diseases, pregnancy\n* Participants taking nutritional supplements and other medicines'}, 'identificationModule': {'nctId': 'NCT06645002', 'acronym': 'Diabetes', 'briefTitle': 'Effect of Stevia Leave Powder on Blood Glucose and Lipid Profile of Diabetic Patients', 'organization': {'class': 'OTHER', 'fullName': 'University of Lahore'}, 'officialTitle': 'Effect of Short and Long-Term Treatment of Stevia Leave Powder on Blood Glucose and Lipid Profile of Diabetic Patients.', 'orgStudyIdInfo': {'id': 'IRB-UOL-FAHS/774/2020'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'short term study', 'description': 'short term study (7 days) stevia leave powder 1000 mg/day', 'interventionNames': ['Dietary Supplement: stevia rebaudiana bertoni']}, {'type': 'EXPERIMENTAL', 'label': 'long term study', 'description': 'Long term study (60 days) stevia leave powder 1000 mg/day', 'interventionNames': ['Dietary Supplement: stevia rebaudiana bertoni']}], 'interventions': [{'name': 'stevia rebaudiana bertoni', 'type': 'DIETARY_SUPPLEMENT', 'description': 'effect of short term study (7 days) of stevia leave powder 1000 mg/day in diabetic subjects', 'armGroupLabels': ['long term study', 'short term study']}, {'name': 'stevia rebaudiana bertoni', 'type': 'DIETARY_SUPPLEMENT', 'description': 'effect of long term study (60 days) of stevia leave powder 1000 mg/day in diabetic subjects', 'armGroupLabels': ['long term study']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38000', 'city': 'Faisalabad', 'state': 'Punjab Province', 'country': 'Pakistan', 'facility': 'Allied Hospital Faisalabad', 'geoPoint': {'lat': 31.41554, 'lon': 73.08969}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Primary reason for not sharing the IPD is to protect participants privacy'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Lahore', 'class': 'OTHER'}, 'collaborators': [{'name': 'Allied Hospital Faisalabad', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD scholar', 'investigatorFullName': 'Fasiha Ahsan', 'investigatorAffiliation': 'University of Lahore'}}}}