Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2026-04-15 @ 7:27 AM
Study NCT ID:
NCT02964533
Status:
UNKNOWN
Last Update Posted:
2016-11-16
First Post:
2016-11-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Thunder-Fire Moxibustion Therapy for Chronic Fatigue Syndrome on Shenque Acupoint: a Randomized Controlled Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015673', 'term': 'Fatigue Syndrome, Chronic'}], 'ancestors': [{'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D004679', 'term': 'Encephalomyelitis'}, {'id': 'D000090862', 'term': 'Neuroinflammatory Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'lastUpdateSubmitDate': '2016-11-15', 'studyFirstSubmitDate': '2016-11-12', 'studyFirstSubmitQcDate': '2016-11-15', 'lastUpdatePostDateStruct': {'date': '2016-11-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-11-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'fatigue rating scale score', 'timeFrame': '5 minutes'}], 'secondaryOutcomes': [{'measure': 'content of peripheral t-lymphocyte subsets', 'timeFrame': '3 minutes'}]}, 'conditionsModule': {'conditions': ['Chronic Fatigue Syndrome']}, 'referencesModule': {'references': [{'pmid': '26939325', 'type': 'BACKGROUND', 'citation': 'Tian L, Wang J, Luo C, Sun R, Zhang X, Yuan B, Du XZ. [Moxibustion at Gaohuang (BL 43) for chronic fatigue syndrome: a randomized controlled trial]. Zhongguo Zhen Jiu. 2015 Nov;35(11):1127-30. Chinese.'}]}, 'descriptionModule': {'briefSummary': 'Chronic fatigue syndrome is a group of syndrome and is prevalent in adult. Thunder-fire moxibustion is a commentary therapy belonged to acupuncture therapy. To evaluate the effect and safety of thunder-fire moxibustion therapy for chronic fatigue syndrome, we apply a randomized controlled trial by recruiting chronic fatigue syndrome patient as subject, applying thunder-fire moxibustion on shenque acupoint contrasted to common moxa-stick moxibustion, taking fatigue rating scale score, the content of CD3+、CD4+、CD8+、CD4+/CD8+ as evaluation indexes. The treatment time is 20-30 minutes per session, 3-4 times a week, there are totally 15 sessions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1.Clinical diagnosis of chronic fatigue syndrome, 2.Age between 18 to 65 years old. 3.Must be able to accept moxibustion treatment 4.Never receive any treatment or has suspended treatment over 2 weeks 5.Patients with good adherence, signed informed consent by themselves\n\nExclusion Criteria:\n\n* 1.Other primary disease caused by chronic fatigue 2.Pregnancy or breast-feeding women. 3.Merge in other serious diseases, such as severe damage in heart, liver, kidney ,lung or mental illness 4.Has took durg for insomnia treatment 5.Has received acupuncture,massage for chronic fatigue syndrome treatment 6.Suffered from infectious disease'}, 'identificationModule': {'nctId': 'NCT02964533', 'briefTitle': 'Thunder-Fire Moxibustion Therapy for Chronic Fatigue Syndrome on Shenque Acupoint: a Randomized Controlled Trial', 'organization': {'class': 'OTHER', 'fullName': 'Guangzhou University of Chinese Medicine'}, 'officialTitle': 'Thunder-Fire Moxibustion Therapy for Chronic Fatigue Syndrome on Shenque Acupoint: a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '20161120'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TFM', 'description': 'thunder-fire moxibustion therapy', 'interventionNames': ['Other: thunder-fire moxibustion therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'MSM', 'description': 'common moxa-stick moxibustion therapy', 'interventionNames': ['Other: common moxa-stick moxibustion']}], 'interventions': [{'name': 'thunder-fire moxibustion therapy', 'type': 'OTHER', 'description': 'burn moxa stick and heat shenque acupoint', 'armGroupLabels': ['TFM']}, {'name': 'common moxa-stick moxibustion', 'type': 'OTHER', 'description': 'burn moxa stick and heat shenque acupoint', 'armGroupLabels': ['MSM']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510120', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'haili luo', 'role': 'CONTACT', 'email': '839601539@qq.com', 'phone': '13825017002'}], 'facility': 'The Second Clinical Medical College of Guangzhou University of Chinese Medicine', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'Haili Luo', 'role': 'CONTACT', 'email': '839601539@qq.com', 'phone': '13825017002'}], 'overallOfficials': [{'name': 'Haili Luo', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Guangdong Provincial Hospital of Traditional Chinese Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Guangzhou University of Chinese Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director', 'investigatorFullName': 'Haili Luo', 'investigatorAffiliation': 'Guangzhou University of Chinese Medicine'}}}}