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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04650295
Other study ID # HUM00185598
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 18, 2021
Est. completion date December 2, 2021

Study information

Verified date December 2021
Source University of Michigan
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 82
Est. completion date December 2, 2021
Est. primary completion date December 2, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Diagnosis of cirrhosis (criteria per protocol will be used) - 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) Exclusion Criteria: - Non-English speaking - Unable or unwilling to provide consent - History of liver transplant - History of multiple sclerosis - History of cerebral palsy - History of stroke with paralysis

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Household Remedy
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.
Tap water
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.

Locations

Country Name City State
United States University of Michigan Ann Arbor Michigan

Sponsors (1)

Lead Sponsor Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Secondary Number of cramp-days per person 28 days
Secondary 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). 28 days
Secondary Number of cramps during study 28 days
Secondary 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
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