Non-Pharmaceutical Intervention for Cirrhotic Cramps Reduction: The NICCles Trial

December 2, 2021 updated by: Elliot B. Tapper, University of Michigan

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

82

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Household Remedy
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.
Placebo Comparator: Tap Water
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction in cramp severity after 28-days as measured by the Visual Analog Scale for Cramps
Time Frame: 28 days
This is a scale that is numbered from 0 (means no cramps) to 10 (worst cramps imaginable).
28 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of cramp-days per person
Time Frame: 28 days
28 days
Number of days with cramp severity less than 5 on the Visual Analog Scale for Cramps
Time Frame: 28 days
This is a scale that is numbered from 0 (means no cramps) to 10 (worst cramps imaginable).
28 days
Number of cramps during study
Time Frame: 28 days
28 days
Change in sleep quality based on the Pittsburgh Sleep Quality Index (PSQI)
Time Frame: baseline, 28 days
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Michigan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 18, 2021

Primary Completion (Actual)

December 2, 2021

Study Completion (Actual)

December 2, 2021

Study Registration Dates

First Submitted

November 24, 2020

First Submitted That Met QC Criteria

November 24, 2020

First Posted (Actual)

December 2, 2020

Study Record Updates

Last Update Posted (Actual)

December 3, 2021

Last Update Submitted That Met QC Criteria

December 2, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HUM00185598

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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