Ignite Creation Date:
2025-12-24 @ 1:37 PM
Ignite Modification Date:
2025-12-28 @ 9:01 AM
Study NCT ID:
NCT04650295
Status:
COMPLETED
Last Update Posted:
2021-12-03
First Post:
2020-11-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Non-Pharmaceutical Intervention for Cirrhotic Cramps Reduction: The NICCles Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D009120', 'term': 'Muscle Cramp'}, {'id': 'D001201', 'term': 'Ascites'}, {'id': 'D008107', 'term': 'Liver Diseases'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 82}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2021-12-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-12-02', 'studyFirstSubmitDate': '2020-11-24', 'studyFirstSubmitQcDate': '2020-11-24', 'lastUpdatePostDateStruct': {'date': '2021-12-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reduction in cramp severity after 28-days as measured by the Visual Analog Scale for Cramps', 'timeFrame': '28 days', 'description': 'This is a scale that is numbered from 0 (means no cramps) to 10 (worst cramps imaginable).'}], 'secondaryOutcomes': [{'measure': 'Number of cramp-days per person', 'timeFrame': '28 days'}, {'measure': 'Number of days with cramp severity less than 5 on the Visual Analog Scale for Cramps', 'timeFrame': '28 days', 'description': 'This is a scale that is numbered from 0 (means no cramps) to 10 (worst cramps imaginable).'}, {'measure': 'Number of cramps during study', 'timeFrame': '28 days'}, {'measure': 'Change in sleep quality based on the Pittsburgh Sleep Quality Index (PSQI)', 'timeFrame': 'baseline, 28 days', 'description': 'This study uses one question from the Pittsburgh Sleep Quality Index (PSQI) in which the participants reply how their sleep quality during the past month has been. Responses include: Very Good (0), Good (1), Fair (2), Bad (3), and Very Bad (4) the higher the score the worse the quality of sleep.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Liver disease', 'Nutrition', 'quality of life', 'sleep', 'non-pharmaceutical intervention'], 'conditions': ['Cirrhosis', 'Muscle Cramp', 'Ascites']}, 'descriptionModule': {'briefSummary': 'This clinical trial is evaluating the feasibility of using a non-pharmaceutical treatment to improve the symptoms and severity of muscle cramps in patients with cirrhosis.\n\nEligible participants will be randomized to the treatment arm or control group. The treatment phase of the study will last 28 days. Information about participants will be collected including surveys and assessments throughout the study. Please note that only the participants randomized to experimental intervention group (Household Remedy) will be told what the treatment is during the study period. At the conclusion of the study (time of the final follow-up assessments), all participants will be debriefed on the use of concealment in this study as outlined in the protocol regarding the intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of cirrhosis (criteria per protocol will be used)\n* History of painful muscle spasms, cramps, or charley horses that come on while resting (they had to have happened 4 times in the past month and bother the participant)\n\nExclusion Criteria:\n\n* Non-English speaking\n* Unable or unwilling to provide consent\n* History of liver transplant\n* History of multiple sclerosis\n* History of cerebral palsy\n* History of stroke with paralysis'}, 'identificationModule': {'nctId': 'NCT04650295', 'briefTitle': 'Non-Pharmaceutical Intervention for Cirrhotic Cramps Reduction: The NICCles Trial', 'organization': {'class': 'OTHER', 'fullName': 'University of Michigan'}, 'officialTitle': 'Non-Pharmaceutical Intervention for Cirrhotic Cramps Reduction: The NICCles Trial', 'orgStudyIdInfo': {'id': 'HUM00185598'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Household Remedy', 'interventionNames': ['Other: Household Remedy']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Tap Water', 'interventionNames': ['Other: Tap water']}], 'interventions': [{'name': 'Household Remedy', 'type': 'OTHER', 'description': 'If the participant experiences a muscle cramp one tablespoon (one sip) of the household product will be taken. The treatment phase of the study will be for 28 days.', 'armGroupLabels': ['Household Remedy']}, {'name': 'Tap water', 'type': 'OTHER', 'description': 'If the participant experiences a muscle cramp one tablespoon (one sip) of tap water will be taken. The treatment phase of the study will be for 28 days.', 'armGroupLabels': ['Tap Water']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}], 'overallOfficials': [{'name': 'Elliot Tapper, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Michigan'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Michigan', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Internal Medicine', 'investigatorFullName': 'Elliot B. Tapper', 'investigatorAffiliation': 'University of Michigan'}}}}