Ignite Creation Date:
2025-12-25 @ 3:32 AM
Ignite Modification Date:
2025-12-26 @ 2:14 AM
Study NCT ID:
NCT00219505
Status:
TERMINATED
Last Update Posted:
2017-11-24
First Post:
2005-09-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Acupuncture on Symptoms of Diarrhea and Pain in IBS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D043183', 'term': 'Irritable Bowel Syndrome'}, {'id': 'D015746', 'term': 'Abdominal Pain'}], 'ancestors': [{'id': 'D003109', 'term': 'Colonic Diseases, Functional'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}]}, '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'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'count': 36}}, 'statusModule': {'whyStopped': 'no eligible subjects identified during recruitment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2001-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2004-01'}, 'lastUpdateSubmitDate': '2017-11-21', 'studyFirstSubmitDate': '2005-09-14', 'studyFirstSubmitQcDate': '2005-09-14', 'lastUpdatePostDateStruct': {'date': '2017-11-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2005-09-22', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Frequency of bowel movement'}], 'secondaryOutcomes': [{'measure': 'Abdominal pain'}]}, 'conditionsModule': {'keywords': ['Diarrhea-predominant irritable bowel syndrome', 'Acupuncture', 'abdominal pain'], 'conditions': ['Irritable Bowel Syndrome']}, 'descriptionModule': {'briefSummary': 'Acupuncture has been used for centuries in China in the treatment of diarrhea. Our hypothesis is that acupuncture is effective in the treatment of abdominal pain and diarrhea in patients with diarrhea-predominant IBS', 'detailedDescription': 'Patients will complete a diary to determine if they qualify for the study. Patients will be randomized to receive either acupuncture or sham acupuncture (needle insertion 1 cm away from acupuncture site). Patients will be blinded to whether they are receiving acupuncture or sham acupuncture. The acupuncturist is blinded as to the patient response. The patients will undergo venupuncture to draw blood to determine sertotonin and beta-endorphin levels. They will receive treatment in 12 sessions over 4 weeks. They will maintain a diary during this time period to document level of pain and frequency of bowel movements. Blood will be drawn at week 2 and 4 and, 6 weeks after cessation of treatment, subjects will again record abdominal symptoms and frequency of bowel movements for 2 weeks. Blood will be drawn for hormone levels at 8 weeks after completion of study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* frequence of bowel movement of at least 3/day\n* global disease severity of at least 3\n\nExclusion Criteria:\n\n* taking medications which will influence frequency of bowel movement\n* patient taking anticoagulants or suffering from coagulopathy\n* pregancy'}, 'identificationModule': {'nctId': 'NCT00219505', 'briefTitle': 'Effect of Acupuncture on Symptoms of Diarrhea and Pain in IBS', 'organization': {'class': 'OTHER', 'fullName': 'Penn State University'}, 'officialTitle': 'Effect of Acupuncture on Symptoms of Diarrhea and Pain in Diarrhea Predominant Irritable Bowel Syndrome (IBS) and Effect on Plasma Beta-endorphin and Serotonin Levels.', 'orgStudyIdInfo': {'id': '2000-343'}}, 'armsInterventionsModule': {'interventions': [{'name': 'acupuncture', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '17033', 'city': 'Hershey', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Hershey Medical Center', 'geoPoint': {'lat': 40.28592, 'lon': -76.65025}}], 'overallOfficials': [{'name': 'Ann Ouyangm, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Penn State College of Medicine and Penn State Milton S. Hershey Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Penn State University', 'class': 'OTHER'}, 'collaborators': [{'name': 'American College of Gastroenterology', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}