Ignite Creation Date:
2025-12-24 @ 3:03 PM
Ignite Modification Date:
2025-12-29 @ 11:51 PM
Study NCT ID:
NCT05749159
Status:
UNKNOWN
Last Update Posted:
2023-03-03
First Post:
2023-02-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
New Physitherapy or Alternative Therapy for Hiccup
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006606', 'term': 'Hiccup'}], 'ancestors': [{'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D026741', 'term': 'Physical Therapy Modalities'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012046', 'term': 'Rehabilitation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-03-01', 'studyFirstSubmitDate': '2023-02-18', 'studyFirstSubmitQcDate': '2023-02-18', 'lastUpdatePostDateStruct': {'date': '2023-03-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the rate of termination of hiccup in 30 seconds', 'timeFrame': '1 year', 'description': 'the rate of termination of hiccup in 30 seconds'}, {'measure': 'the time course from the start of therapy to the end of hicuup', 'timeFrame': '1 year', 'description': 'the time course from the start of therapy to the end of hicuup'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['hiccup'], 'conditions': ['Hiccup']}, 'descriptionModule': {'briefSummary': 'Hiccup is a common symptom, and it is currently believed that hiccups result from diaphragmatic spasm, with onset ranging from minutes to days. Some patients may terminate on their own, or by ways such as gasping. For some patients with duration longer than 1 day, even longer than 2 days, medications may be needed, mainly: metoclopramide, eperisone hydrochloride tablets, etc. Acupuncture is also effective for some patients. Surgical treatment may be required for some clinically intractable hiccups. However, for the above interventions or treatment means, the current efficacy still needs to be improved.\n\nIn the previous clinical experience, we create a new physical clinic protocol which could terminate the hiccup symptom onset instantaneously without adding extra cost to the patient, and the physiotherapy method was convenient and effective. To further validate the superiority, safety of this novel physical therapy regimen, we designed a randomised controlled, prospective, single centre clinical study aimed at comparing the efficacy and safety of the novel physical therapy with conventional pharmacotherapy in patients with hiccups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years\n* Able to swallow water\n\nExclusion Criteria:\n\n* Allergy or contraindication to the following drugs: metoclopramide et al\n* Severe choking on water and difficulty swallowing were present\n* Impaired consciousness and inability to cooperate'}, 'identificationModule': {'nctId': 'NCT05749159', 'acronym': 'HICCUP', 'briefTitle': 'New Physitherapy or Alternative Therapy for Hiccup', 'organization': {'class': 'OTHER', 'fullName': 'Second Affiliated Hospital, School of Medicine, Zhejiang University'}, 'officialTitle': 'Comparison of New pHysIotherapy With Alternative Therapy for Clinical outComes in Patients With hiccUP: Rationale and Design of a Randomized Clinical Trail', 'orgStudyIdInfo': {'id': '2023-0115'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'physiotherapy', 'description': 'New physical therapy: a disposable cup (soft cup) to take 1/3 cup of room temperature water and place it on a table. The patient takes a sitting or standing position. The middle finger of both hands press tightly against the nose to seal the nasal cavity. At the same time, press the ear screen with both hands to close the ear canal. After that, bite the cup with teeth (hands do not touch the cup), and drink up 1-2 mouthfuls of water.', 'interventionNames': ['Behavioral: physiotherapy']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'alternative therapy', 'description': 'Alternative therapy: including routine physical therapy such as suffocation and drinking cold water, as well as drug therapy such as metoclopramide and Mianna.', 'interventionNames': ['Behavioral: physiotherapy']}], 'interventions': [{'name': 'physiotherapy', 'type': 'BEHAVIORAL', 'description': 'New physical therapy: a disposable cup (soft cup) to take 1/3 cup of room temperature water and place it on a table. The patient takes a sitting or standing position. The middle finger of both hands press tightly against the nose to seal the nasal cavity. At the same time, press the ear screen with both hands to close the ear canal. After that, bite the cup with teeth (hands do not touch the cup), and drink up 1-2 mouthfuls of water.', 'armGroupLabels': ['alternative therapy', 'physiotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '310000', 'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Shen Jian', 'role': 'CONTACT', 'email': 'sjcardiology@163.com', 'phone': '13634134320'}], 'facility': '2nd Affiliated Hospital, School of Medicine, Zhejiang University', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'centralContacts': [{'name': 'Shen Jian', 'role': 'CONTACT', 'email': 'sjcardiology@163.com', 'phone': '+86 13634134320'}], 'overallOfficials': [{'name': 'Shen Jian', 'role': 'STUDY_CHAIR', 'affiliation': 'Second Affiliated Hospital, School of Medicine, Zhejiang University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Second Affiliated Hospital, School of Medicine, Zhejiang University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}