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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.
Eligible 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Household Remedy | Experimental |
| |
| Tap Water | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Household Remedy | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in cramp severity after 28-days as measured by the Visual Analog Scale for Cramps | This is a scale that is numbered from 0 (means no cramps) to 10 (worst cramps imaginable). | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of cramp-days per person | 28 days | |
| Number of days with cramp severity less than 5 on the Visual Analog Scale for Cramps | This is a scale that is numbered from 0 (means no cramps) to 10 (worst cramps imaginable). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elliot Tapper, MD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
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| ID | Term |
|---|---|
| D005355 | Fibrosis |
| D009120 | Muscle Cramp |
| D001201 | Ascites |
| D008107 | Liver Diseases |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
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| Tap water | Other | 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. |
|
| 28 days |
| Number of cramps during study | 28 days |
| Change in sleep quality based on the Pittsburgh Sleep Quality Index (PSQI) | 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. | baseline, 28 days |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D004066 | Digestive System Diseases |