Ignite Creation Date:
2025-12-25 @ 5:11 AM
Ignite Modification Date:
2026-01-10 @ 1:03 AM
Study NCT ID:
NCT06520527
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-25
First Post:
2024-07-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of the Effectiveness of Sambiloto Herbs (Andrographis Paniculata) and Brisk Walking Exercise on Blood Pressure of Obese Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000713167', 'term': 'Andrographis paniculata extract'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-07-21', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2024-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-21', 'studyFirstSubmitDate': '2024-07-21', 'studyFirstSubmitQcDate': '2024-07-21', 'lastUpdatePostDateStruct': {'date': '2024-07-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Systole and Diastole Differences', 'timeFrame': '7 consecutive days', 'description': 'Difference in Systole and Diastole before and after treatment'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Obese'], 'conditions': ['MeSH']}, 'descriptionModule': {'briefSummary': 'Problem Formulation\n\n1. Is there an effect of giving jamu sambiloto (Andrographis paniculata) on blood pressure in obese people in Jekan Raya District?\n2. Is there an effect of brisk walking exercise on blood pressure in obese people in Jekan Raya District?\n3. Is there an effect of brisk walking exercise and combined administration of jamu sambiloto (Andrographis paniculata) on blood pressure in obese people in Jekan Raya District?\n4. Is there a difference in effectiveness between the administration of jamu sambiloto (Andrographis paniculata) and brisk walking exercise and the combination on blood pressure in obese people in Jekan Raya District?\n\nResearch Objectives\n\nGeneral Objective:\n\nThis study aims to determine the difference in effectiveness between the administration of jamu sambiloto (Andrographis paniculata) and brisk walking exercise on blood pressure in obese people in Jekan Raya District.\n\nSpecific Objectives:\n\nThis study specifically aims to:\n\n1. Knowing the effect on blood pressure of obese people in Jekan Raya District before and after giving Jamu Sambiloto (Andrographis paniculata).\n2. Knowing the effect on blood pressure of obese people in Jekan Raya District before and after doing Brisk Walking Exercise.\n3. Knowing the effect before and after giving Jamu Sambiloto (Andrographis paniculata) and Brisk Walking Exercise on Blood Pressure in obese people in Jekan Raya District.', 'detailedDescription': 'This type of research uses the Quasi Experimental method type Non-equivalent control group design, with a research design in the form of two group pre test and post test design, in this study there are two groups that will be measured pretest before intervention and post test after intervention and 1 control group without being given intervention. The intervention group is divided into two groups, namely the group given the sambiloto herbal medicine, and the group given the Brisk Walking Exercise treatment. Quasi-experimental research design with research design in the form of two group pre test and post test design.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '39 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria in this study are:\n\nBody Mass Index (BMI) ≥ 25 kg/m2 (Obesity 1) Blood pressure does not exceed 139/89 mmHg (High Normal) Adult age (19-39 years) Willing to be a respondent with informed consent Have health insurance coverage\n\nExclusion Criteria\n\nExclusion criteria in this study are:\n\nNot in place or out of town during the study Experiencing illness that cannot carry out research interventions and data collection Resign during the study Routine exercise (Exercise every day less than 6000 steps). Taking anti-hypertensive drugs regularly Pregnant and breastfeeding mothers Routinely consume jamu sambiloto History of bone and joint disease that prevents physical activity History of cardiovascular or kidney disease'}, 'identificationModule': {'nctId': 'NCT06520527', 'briefTitle': 'Comparison of the Effectiveness of Sambiloto Herbs (Andrographis Paniculata) and Brisk Walking Exercise on Blood Pressure of Obese Patients', 'organization': {'class': 'OTHER', 'fullName': 'Universitas Palangka Raya'}, 'officialTitle': 'Comparison of the Effectiveness of Sambiloto Herbs (Andrographis Paniculata) and Brisk Walking Exercise on Blood Pressure of Obese Patients', 'orgStudyIdInfo': {'id': '2504031945'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Brisk Walking Exercise', 'description': 'Moderate activity that uses brisk walking techniques for 30 minutes at an average speed of up to 5 km/h or 100 steps per minute.a', 'interventionNames': ['Behavioral: Brisk Walking Exercise']}, {'type': 'EXPERIMENTAL', 'label': 'Andrographis Paniculata', 'description': 'Jamu Sambiloto is herbal medicine obtained through products that already have a distribution permit and have a distribution permit registration number, with a consumption dose of 1 capul / day or 350 grams for 7 consecutive days.', 'interventionNames': ['Dietary Supplement: Andrographis paniculata']}, {'type': 'EXPERIMENTAL', 'label': 'Combination', 'description': 'Moderate activity that uses brisk walking techniques for 30 minutes at an average speed of up to 5 km/h or 100 steps per minute.a\n\nJamu Sambiloto is herbal medicine obtained through products that already have a distribution permit and have a distribution permit registration number, with a consumption dose of 1 capul / day or 350 grams for 7 consecutive days.', 'interventionNames': ['Other: Combination']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Obese with no intervention'}, {'type': 'NO_INTERVENTION', 'label': 'Normal', 'description': 'Normal with no intervention'}], 'interventions': [{'name': 'Andrographis paniculata', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Jamu Sambiloto is herbal medicine obtained through products that already have a distribution permit and have a distribution permit registration number, with a consumption dose of 1 capul / day or 350 grams for 7 consecutive days.', 'armGroupLabels': ['Andrographis Paniculata']}, {'name': 'Brisk Walking Exercise', 'type': 'BEHAVIORAL', 'description': 'Moderate activity that uses brisk walking techniques for 30 minutes at an average speed of up to 5 km/h or 100 steps per minute.', 'armGroupLabels': ['Brisk Walking Exercise']}, {'name': 'Combination', 'type': 'OTHER', 'description': 'Moderate activity that uses brisk walking techniques for 30 minutes at an average speed of up to 5 km/h or 100 steps per minute.\n\nJamu Sambiloto is herbal medicine obtained through products that already have a distribution permit and have a distribution permit registration number, with a consumption dose of 1 capul / day or 350 grams for 7 consecutive days.', 'armGroupLabels': ['Combination']}]}, 'contactsLocationsModule': {'locations': [{'zip': '73111', 'city': 'Palangkaraya', 'state': 'Central Kalimantan', 'country': 'Indonesia', 'contacts': [{'name': 'Muhammad Revo Andaluzio Sazly Revo Sazly', 'role': 'CONTACT', 'email': 'revosazly1@gmail.com', 'phone': '+6281808154654'}, {'name': 'Muhammad Revo Andaluzio Sazly Revo Sazly', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Sports Facilities', 'geoPoint': {'lat': -2.20833, 'lon': 113.91667}}], 'centralContacts': [{'name': 'Muhammad Revo Andaluzio Sazly Revo Sazly', 'role': 'CONTACT', 'email': 'revosazly1@gmail.com', 'phone': '+6281808154654'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitas Palangka Raya', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Agnes Veronica Agustin', 'investigatorFullName': 'Agnes Veronica Agustin', 'investigatorAffiliation': 'Universitas Palangka Raya'}}}}