Ignite Creation Date:
2025-12-24 @ 7:18 PM
Ignite Modification Date:
2025-12-30 @ 1:54 AM
Study NCT ID:
NCT02254603
Status:
UNKNOWN
Last Update Posted:
2014-10-02
First Post:
2014-09-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects of the Combined Therapy of Acupuncture and Yoga Exercise on Weight Loss
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': 'D015670', 'term': 'Acupuncture Therapy'}], 'ancestors': [{'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 74}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-09', 'completionDateStruct': {'date': '2015-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-09-29', 'studyFirstSubmitDate': '2014-09-25', 'studyFirstSubmitQcDate': '2014-09-29', 'lastUpdatePostDateStruct': {'date': '2014-10-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-10-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reduce body mass index.', 'timeFrame': 'Change from baseline in body mass index at 3 months', 'description': 'Outcome measure compares the change in body mass index during 3 months treatment.'}], 'secondaryOutcomes': [{'measure': 'Reduce waistline', 'timeFrame': 'Change from baseline in waistline at 3 months', 'description': 'Outcome measure compares the change in waistline during 3 months treatment.'}, {'measure': 'Change biochemical profile of blood', 'timeFrame': 'Change from baseline in biochemical profile of blood at 3 months', 'description': 'Outcome measure compares the changes in biochemical profile of blood including cholesterol/high-density lipoprotein/low-density lipoprotein/blood sugar during 3 months treatment. Peripheral blood will be collected at 2 different times. (1) baseline data: before intervention, (2) outcome data: at 3 months post-intervention.'}, {'measure': 'Immune modulation', 'timeFrame': 'Change from baseline in lymphocyte profile and polarization at 3 months', 'description': 'Immune function will be assessed by blood analysis including lymphocyte subpopulations (Th1/ Th2/ Treg/ Th17), polarization (T-bet/ Gata-3/ Foxp3/ RORrt), its related cytokines (Th1: IL-12/ IFN-γ/ IL-27; Th2: IL-4/ IL-13/ IL-25; Th17: IL-17A/ IL-6/ IL-21; Treg: TGF-β/ IL-10) during 3 months treatment. Peripheral blood will be collected at 2 different times. (1) baseline data: before intervention, (2) outcome data: at 3 months post-intervention.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Obesity, ayuveda yoga exercise, acupuncture.'], 'conditions': ['Obesity']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to examine the effects of combination of acupuncture and ayuveda yoga exercise on weight loss for the overweight.', 'detailedDescription': "Obesity is a common health problem in developed countries. At present,the medical staff have already been alerted that the obesity is a kind of disease actually and one of the epidemic diseases which erode the human health in the world. It is not only about the person's health but also a main public health problem. It has been caught to our attention that some diseases, such as cardiovascular diseases,diabetes, and high blood pressure are coming along with overweight and obesity. Recent studies had demonstrated a positive correlation between chronic diseases and obesity. There are many treatments for the obesity, in general, acupuncture may be an effective one. Acupuncture may suppress the people's appetite, slow down the stomach's creeping motion, and increase the stomach's evacuation time. Simultaneously, acupuncture controls the body through the absorption and storage of the calorie via the adjustment of the endocrine system. But we still need a more efficiency way to accelerate the body fat metabolism and decrease the storage of the fat in vivo. Therefore, the purpose of this study is to examine the effects of combination of acupuncture and ayuveda yoga exercise on weight loss among the overweight."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI \\> 24\n\nExclusion Criteria:\n\n* Diagnosis of cancer.'}, 'identificationModule': {'nctId': 'NCT02254603', 'briefTitle': 'The Effects of the Combined Therapy of Acupuncture and Yoga Exercise on Weight Loss', 'organization': {'class': 'OTHER', 'fullName': 'Chang Bing Show Chwan Memorial Hospital'}, 'officialTitle': 'To Evaluate the Effects of Weight-loss by the Combined Therapy of Acupuncture and Yoga Exercise', 'orgStudyIdInfo': {'id': '1011003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Acupuncture controls', 'description': 'Acupuncture group will receive 30-minutes treatment three times a week for 3 months.', 'interventionNames': ['Device: Acupuncture']}, {'type': 'EXPERIMENTAL', 'label': 'acupuncture and yoga exercise', 'description': 'Subject will receive a combination of acupuncture and yoga exercise three times a week for 3 months.', 'interventionNames': ['Device: Acupuncture', 'Behavioral: Yoga exercise']}], 'interventions': [{'name': 'Acupuncture', 'type': 'DEVICE', 'description': 'Acupuncture about 30 mins will be performed by a traditional Chinese physician three times a week for 3 months.', 'armGroupLabels': ['Acupuncture controls', 'acupuncture and yoga exercise']}, {'name': 'Yoga exercise', 'type': 'BEHAVIORAL', 'description': 'Subject will receive regular 60-minutes yoga exercise three times a week for 3 months.', 'armGroupLabels': ['acupuncture and yoga exercise']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Changhua County', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Kuender D. Yang, PhD', 'role': 'CONTACT', 'email': 'yangkd.yeh@hotmail.com', 'phone': '886-975617006'}], 'facility': 'Division of Core Laboratory; Chang Bing Show Chwan Memorial Hospital'}], 'centralContacts': [{'name': 'Kuender D. Yang, PhD', 'role': 'CONTACT', 'email': 'yehshuhui@gmail.com', 'phone': '886-975617006'}], 'overallOfficials': [{'name': 'Kuender D. Yang, PhD.', 'role': 'STUDY_CHAIR', 'affiliation': 'Chang Bing Show Chwan Memorial Hospital'}, {'name': 'Shu-Hui Yeh, PhD.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Chang Bing Show Chwan Memorial Hospital & Central Taiwan University of Science and Technology'}, {'name': 'Yu-Kwan Lu, MD.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Show Chwan Memorial Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chang Bing Show Chwan Memorial Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'RN, PhD, Professor', 'investigatorFullName': 'Shu-Hui Yeh', 'investigatorAffiliation': 'Chang Bing Show Chwan Memorial Hospital'}}}}