Ignite Creation Date:
2025-12-25 @ 12:37 AM
Ignite Modification Date:
2025-12-28 @ 9:15 PM
Study NCT ID:
NCT04557267
Status:
COMPLETED
Last Update Posted:
2021-06-03
First Post:
2020-09-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dose-ranging Study of SKF7™ for Obesity
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': 'D003276', 'term': 'Contraceptives, Oral'}], 'ancestors': [{'id': 'D003271', 'term': 'Contraceptive Agents, Female'}, {'id': 'D003270', 'term': 'Contraceptive Agents'}, {'id': 'D012102', 'term': 'Reproductive Control Agents'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Active drug and placebo are made in similar'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '4 parallel groups, 3 doses of study drug versus placebo'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 160}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-09-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2021-05-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-06-02', 'studyFirstSubmitDate': '2020-09-07', 'studyFirstSubmitQcDate': '2020-09-15', 'lastUpdatePostDateStruct': {'date': '2021-06-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Incidence of abnormal vital signs and of abnormal laboratory test results', 'timeFrame': '12 weeks', 'description': 'Abnormality of vital signs and laboratory test results'}, {'measure': 'Incidence of Adverse Events', 'timeFrame': '12 weeks', 'description': 'The incidence and percentage of Adverse events and serious adverse events'}], 'primaryOutcomes': [{'measure': 'Change in body weight', 'timeFrame': '12 weeks', 'description': 'Percentage of subjects whose Body Weight is lowered'}, {'measure': 'Change in waist and hip circumferences', 'timeFrame': '12 weeks', 'description': 'Change in waist and hip circumference'}, {'measure': 'Change in the waist-hip and waist-height ratios', 'timeFrame': '12 weeks', 'description': 'Change in waist-hip ratio and waist-height ratio'}, {'measure': 'Change in Body Mass Index (BMI)', 'timeFrame': '12 weeks', 'description': 'Change in BMI in kg/m\\^2'}], 'secondaryOutcomes': [{'measure': 'Body fat percentage', 'timeFrame': '12 weeks', 'description': 'The change of body fat percentage'}, {'measure': 'Lean Body Mass', 'timeFrame': '12 weeks', 'description': 'The amount of lean body mass will be calculated from body fat percentage'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['dose-ranging', 'Kacip Fatimah', 'Labisia pumila', 'obesity'], 'conditions': ['Obesity']}, 'referencesModule': {'references': [{'pmid': '30235727', 'type': 'RESULT', 'citation': 'Lee S, Lee H, Cho Y, Kim J, Kang JW, Seo BK, Baek YH, Lee JD. The efficacy and safety of Hanslim for obese patients: Study protocol for a multicenter, randomized, double-blind, multi-dose, placebo-controlled, phase IIb clinical trial. Medicine (Baltimore). 2018 Sep;97(38):e12440. doi: 10.1097/MD.0000000000012440.'}], 'seeAlsoLinks': [{'url': 'https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-clinical-evaluation-medicinal-products-used-weight-management-revision-1_en.pdf', 'label': 'EMA Guideline on clinical evaluation of medicinal products used in weight control'}, {'url': 'https://apps.who.int/iris/handle/10665/206936', 'label': 'The Asia-Pacific Perspective: Redefining Obesity and its Treatment'}]}, 'descriptionModule': {'briefSummary': 'This study has been designed as a randomized, double blinded, multi-centric, placebo controlled, and phase II dose-ranging study. The herbal drug contains bioactive ingredients from Labisia pumila plant and it is an aqueous ethanolic standardized extract (SKF7™).', 'detailedDescription': 'Labisia pumila or Kacip Fatimah is a native Malaysian and Indonesian plant. It has been used as traditional medicine for over 400 years by both men and women for multiple treatments including toning and firming the abdominal area. As a water-ethanol dry extract, it has been reported to reduce body weight, cholesterol level and triglyceride level, and regulate blood glucose and sex hormones. In Malaysia, this Kacip Fatimah extract has been used as a natural anti-obesity drug and dietary supplement for healthy weight loss and healthy body by the trade-name of Labeesity® or SKF7™. This extract has been shown to be pesticide / herbicide free and has branded halal ingredient identity and security.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Men aged 18 - 50 yrs or women aged 18 until before perimenopause, with obesity\n2. Willing to participate in the study by signing the informed consent\n3. Healthy by anamnesis\n4. Agreed to maintain their current lifestyles (no changes in their diet and physical exercise) during the clinical trial period.\n\nExclusion Criteria:\n\n1. Positive result for Rapid test for COVID-19 at screening period.\n2. Known hypersensitivity to any herbal product.\n3. Pregnant or lactating women.\n4. Taking any other weight loss therapy and/or lipid lowering products.\n5. Participate in other interventional clinical study or have taken other investigational drug within 30 days prior to screening.'}, 'identificationModule': {'nctId': 'NCT04557267', 'briefTitle': 'Dose-ranging Study of SKF7™ for Obesity', 'organization': {'class': 'OTHER', 'fullName': 'Indonesia University'}, 'officialTitle': 'Dose-ranging Study of Labisia Pumila Aqueous Ethanolic Standardized Extract (SKF7™) for Obesity: a Randomized, Double-blind, Placebo-controlled, Phase-2 Study', 'orgStudyIdInfo': {'id': 'CRSU.P.SKF7F2/1019/04.08'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A (dosage A)', 'description': 'The lower dose of the active drug', 'interventionNames': ['Drug: low-dose']}, {'type': 'EXPERIMENTAL', 'label': 'Group B (dosage 2)', 'description': 'The middle dose of the active drug', 'interventionNames': ['Drug: Middle-dose']}, {'type': 'EXPERIMENTAL', 'label': 'Group C (dosage 3)', 'description': 'The higher dose of the active drug', 'interventionNames': ['Drug: Higher-dose']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Group D (placebo)', 'description': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'low-dose', 'type': 'DRUG', 'description': 'Dosage 1', 'armGroupLabels': ['Group A (dosage A)']}, {'name': 'Middle-dose', 'type': 'DRUG', 'description': 'Dosage 2', 'armGroupLabels': ['Group B (dosage 2)']}, {'name': 'Higher-dose', 'type': 'DRUG', 'description': 'Dosage 3', 'armGroupLabels': ['Group C (dosage 3)']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo', 'armGroupLabels': ['Group D (placebo)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10430', 'city': 'Jakarta', 'state': 'DKI Jakarta', 'country': 'Indonesia', 'facility': 'Indonesia Medical Education and Research Institute', 'geoPoint': {'lat': -6.21462, 'lon': 106.84513}}, {'zip': '11510', 'city': 'Jakarta', 'state': 'DKI Jakarta', 'country': 'Indonesia', 'facility': 'Faculty of Medicine, Krida Wacana Christian University', 'geoPoint': {'lat': -6.21462, 'lon': 106.84513}}, {'zip': '16424', 'city': 'Depok', 'state': 'West Java', 'country': 'Indonesia', 'facility': 'Makara Satellite Clinic', 'geoPoint': {'lat': -6.4, 'lon': 106.81861}}], 'overallOfficials': [{'name': 'Arini Setiawati, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Clinical Research Supporting Unit, Faculty of Medicine, University of Indonesia'}, {'name': 'Nafrialdi Agus, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Pharmacology & Therapeutics, Faculty of Medicine, Universitas Indonesia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Indonesia University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Medika Natura Sdn Bhd', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Nafrialdi', 'investigatorAffiliation': 'Indonesia University'}}}}