Ignite Creation Date:
2025-12-24 @ 6:58 PM
Ignite Modification Date:
2025-12-28 @ 6:48 PM
Study NCT ID:
NCT01360957
Status:
WITHDRAWN
Last Update Posted:
2015-11-18
First Post:
2011-05-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Consumption of Black Cumin (Nigella Sativa L.) Water Extract on Weight Loss in Overweight Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Iran']}, '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Mahnaz Kazemipoor has not handed over human subject review board approval letter to her colleague.', 'overallStatus': 'WITHDRAWN', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-02', 'completionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-11-17', 'studyFirstSubmitDate': '2011-05-24', 'studyFirstSubmitQcDate': '2011-05-24', 'lastUpdatePostDateStruct': {'date': '2015-11-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-05-26', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'BP (blood pressure)', 'timeFrame': '0 and12 weeks', 'description': 'Change from Baseline in Systolic Blood Pressure at 12 weeks'}, {'measure': 'HR (heart rate)', 'timeFrame': '0 and 12 weeks', 'description': 'Change from Baseline in heart rate at 12 weeks'}, {'measure': 'Body water (percentage)', 'timeFrame': '0 and 12 weeks', 'description': 'Change from Baseline in body water at 12 weeks'}, {'measure': 'Fat free mass (percentage)', 'timeFrame': '0 and 12 weeks', 'description': 'Change from Baseline in fat free mass at 12 weeks'}, {'measure': 'Fat mass (percentage)', 'timeFrame': '0 and 12 weeks', 'description': 'Change from Baseline in fat mass at 12 weeks'}, {'measure': 'Bone mass', 'timeFrame': '0 and 12 weeks', 'description': 'Change from Baseline in bone mass at 12 weeks'}, {'measure': 'BMR (basic metabolic rate)', 'timeFrame': '0 and12 weeks', 'description': 'Change from Baseline in BMR at 12 weeks'}, {'measure': 'AMR (active metabolic rate)', 'timeFrame': '0 and 12 weeks', 'description': 'Change from Baseline in AMR at 12 weeks'}], 'secondaryOutcomes': [{'measure': 'BMI (body mass index)', 'timeFrame': '0 and 12 weeks', 'description': 'Change from Baseline in BMI at 12 weeks'}, {'measure': 'WHR (waist to hip ratio)', 'timeFrame': '0 and 12 weeks', 'description': 'Change from Baseline in WHR at 12 weeks'}, {'measure': 'MUAC (mid upper arm circumference)', 'timeFrame': '0 and 12 weeks', 'description': 'Change from Baseline in MUAC at 12 weeks'}, {'measure': 'Wrist circumference', 'timeFrame': '0 and 12 weeks', 'description': 'Change from Baseline in wrist circumference at 12 weeks'}, {'measure': 'Changes in appetite as measured by a 10-point visual analog scale (VAS)', 'timeFrame': '0 and 12 weeks', 'description': 'Change from Baseline in VAS at 12 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Obesity'], 'conditions': ['Obesity']}, 'descriptionModule': {'briefSummary': 'The purpose of this clinical trial is to study the therapeutic effect of black cumin water extract (Nigella sativa L.) on obesity and overweight', 'detailedDescription': 'The worldwide prevalence of obesity has reached epidemic proportions mostly in low-income and transitional than in industrialized countries. Changes in dietary habits and sedentary lifestyles are known to be associated with changes in health and increased prevalence of chronic diseases in the population. The need to promote healthy nutrition for the population must be pursued vigorously, as the escalation of nutrition-related chronic degenerative diseases - once an urban phenomenon - has now spread to the rural population at an alarming rate. During the past decades efficacious strategies have been developed for prevention of these diseases. These strategies involve general lifestyle changes, which include, healthy diet, optimal weight, physical activity, moderate or no alcohol consumption, control of diabetes mellitus and in particular, treatment of obesity. Although the global market for satiety, fat burning and other weight management remedies has been grown, the awareness of the benefits of weight management ingredients is neither sufficient nor clearly perceived by consumer. Subsequently, the opportunities for scientifically-substantiated weight management ingredients regarding the natural and herbal dietary pattern are impressive.\n\nThe seed of Nigella sativa (black cumin) is one of the most common traditional herbs for weight loss in the Middle East which is usually used as a spice as well as traditional medicine to treat a variety of health conditions especially inflammatory diseases and obesity.\n\nFurthermore, many of the components present in black cumin including polyphenols have been attributed to have anti-inflammatory and anti-obesity effect which further supports our hypothesis.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '60 Years', 'minimumAge': '16 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Being Obese\n\nExclusion Criteria:\n\n* Having heart disease or renal disease\n* using drugs influencing metabolism and appetite'}, 'identificationModule': {'nctId': 'NCT01360957', 'briefTitle': 'Effect of Consumption of Black Cumin (Nigella Sativa L.) Water Extract on Weight Loss in Overweight Women', 'organization': {'class': 'OTHER', 'fullName': 'Shahid Beheshti University of Medical Sciences'}, 'orgStudyIdInfo': {'id': '23911'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Water flavored placebo', 'description': 'to be given orally in a dosage of 30 ml trice daily for 60 days', 'interventionNames': ['Dietary Supplement: Black cumin water extract as a traditional medicine']}, {'type': 'EXPERIMENTAL', 'label': 'Black cumin water extract as a traditional medicine', 'description': 'Black cumin water extract as a traditional medicine to be given orally in a dosage of 30 ml trice daily for 60 days', 'interventionNames': ['Dietary Supplement: Black cumin water extract as a traditional medicine']}], 'interventions': [{'name': 'Black cumin water extract as a traditional medicine', 'type': 'DIETARY_SUPPLEMENT', 'description': 'to be given orally in a dosage of 30 ml trice daily for 60 days', 'armGroupLabels': ['Black cumin water extract as a traditional medicine', 'Water flavored placebo']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shahid Beheshti University of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Shahid Beheshti University of Medical Sciences', 'oldOrganization': 'Shahid Beheshti University of Medical Sciences'}}}}