Ignite Creation Date:
2025-12-24 @ 4:39 PM
Ignite Modification Date:
2026-02-27 @ 4:08 PM
Study NCT ID:
NCT01863966
Status:
UNKNOWN
Last Update Posted:
2013-05-29
First Post:
2013-05-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hot Water Drinking Therapy in Achalasia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004931', 'term': 'Esophageal Achalasia'}], 'ancestors': [{'id': 'D015154', 'term': 'Esophageal Motility Disorders'}, {'id': 'D003680', 'term': 'Deglutition Disorders'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-05', 'completionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-05-23', 'studyFirstSubmitDate': '2013-05-21', 'studyFirstSubmitQcDate': '2013-05-23', 'lastUpdatePostDateStruct': {'date': '2013-05-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-05-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline achalasia symptom score at 1 month', 'timeFrame': 'baseline and 1 month', 'description': 'Dysphagia, Regurgitation and Chest Pain scores'}], 'secondaryOutcomes': [{'measure': 'Number of patients with adverse effects', 'timeFrame': 'Week 1', 'description': 'adverse effects of drinking water like distention, nausea and belching'}, {'measure': 'Change from baseline in barium esophagram at 1 year', 'timeFrame': 'baseline and 1 year', 'description': 'measure esophageal diameter'}, {'measure': 'Endoscopy at 1 year', 'timeFrame': 'year 1', 'description': 'esophageal bezoars and esophageal cancer'}, {'measure': 'Pneumatic dilation rate and relative efficacy', 'timeFrame': 'any time', 'description': 'Patients who are unsatisfied with hot water drinking therapy are to receive pneumatic dilation'}, {'measure': 'Change from baseline in achalasia symptom score at 1 year', 'timeFrame': 'baseline and 1 year', 'description': 'Dysphagia,Regurgitation and Chest Pain scores'}, {'measure': 'Change from baseline achalasia symptom scores at 5 years', 'timeFrame': 'baseline and 5 years', 'description': 'Dysphagia,Regurgitation and Chest Pain scores'}, {'measure': 'Change from baseline in barium esophagram at 5 years', 'timeFrame': 'baseline and 5 years', 'description': 'measure esophageal diameter'}, {'measure': 'Endoscopy at 5 years', 'timeFrame': 'year 5', 'description': 'esophageal bezoars and esophageal cancer'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Achalasia', 'Hot water drinking therapy', 'Pneumatic dilation'], 'conditions': ['Achalasia']}, 'referencesModule': {'references': [{'pmid': '9649001', 'type': 'RESULT', 'citation': 'Triadafilopoulos G, Tsang HP, Segall GM. Hot water swallows improve symptoms and accelerate esophageal clearance in esophageal motility disorders. J Clin Gastroenterol. 1998 Jun;26(4):239-44. doi: 10.1097/00004836-199806000-00003.'}, {'pmid': '23105999', 'type': 'RESULT', 'citation': 'Ren Y, Ke M, Fang X, Zhu L, Sun X, Wang Z, Wang R, Wei Z, Wen P, Xin H, Chang M. Response of esophagus to high and low temperatures in patients with achalasia. J Neurogastroenterol Motil. 2012 Oct;18(4):391-8. doi: 10.5056/jnm.2012.18.4.391. Epub 2012 Oct 9.'}]}, 'descriptionModule': {'briefSummary': 'From clinical observation that some achalasia patients drink water to help swallow food, the investigators have proposed a systemic hot water drinking therapy. This study is to observe its efficacy on achalasia symptoms and explore its mechanism.', 'detailedDescription': '1. Achalasia patients will participate hot water drinking therapy: to drink 200ml of hot water before and after a meal, as well as 2 hours before sleep and to chew food carefully and swallow with hot soup.\n2. Patients are followed by achalasia associated symptom scores, barium esophagram and endoscopy.\n3. If patients are unsatisfied with hot water drinking therapy, they receive pneumatic dilation'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* achalasia patients diagnosed by endoscopy, barium esophagram and manometry\n\nExclusion Criteria:\n\n* could not drink water\n* poor compliance\n* severe comorbidities\n* esophageal stenosis secondary to erosions and cancer'}, 'identificationModule': {'nctId': 'NCT01863966', 'acronym': 'AHW', 'briefTitle': 'Hot Water Drinking Therapy in Achalasia', 'organization': {'class': 'OTHER', 'fullName': 'Peking Union Medical College Hospital'}, 'officialTitle': 'Efficacy and Safety Study of Hot Water Drinking Therapy in Achalasia Patients', 'orgStudyIdInfo': {'id': 'PUMCH-AchaWater'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Hot water drinking therapy', 'description': 'Hot water drinking before,after meal and before sleep', 'interventionNames': ['Other: hot water drinking therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Pneumatic dilation', 'description': 'Patients who are unsatisfied with hot water drinking therapy are to receive standard pneumatic dilation', 'interventionNames': ['Procedure: Pneumatic dilation']}], 'interventions': [{'name': 'hot water drinking therapy', 'type': 'OTHER', 'description': 'Drink 200ml hot water 3min before and after a meal. Swallow food with hot water and drink 200ml hot water before sleep', 'armGroupLabels': ['Hot water drinking therapy']}, {'name': 'Pneumatic dilation', 'type': 'PROCEDURE', 'description': 'Patients who are unsatisfied with hot water drinking therapy are to receive standard pneumatic dilation under endoscope', 'armGroupLabels': ['Pneumatic dilation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100730', 'city': 'Beijing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Meiyun Ke, M.D.', 'role': 'CONTACT', 'email': 'Kemypumch2006@yahoo.com.cn', 'phone': '+86-10-69155006'}, {'name': 'Yutang Ren, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Meiyun Ke, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Department of Gastroenterology, Peking Union Medical College Hospital, Chinese Academy of Medical Science', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Yutang Ren, M.D.', 'role': 'CONTACT', 'email': 'renytpumc@hotmail.com', 'phone': '+86-020-62786224'}], 'overallOfficials': [{'name': 'Meiyun Ke, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Department of Gastroenterology, Peking Union Medical College Hospital, Chinese Academy of Medical Science'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking Union Medical College Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}