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

NCT ID: NCT04650295

Last Updated: 2021-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-18

Study Completion Date

2021-12-02

Brief Summary

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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.

Detailed Description

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Conditions

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Cirrhosis Muscle Cramp Ascites

Keywords

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Liver disease Nutrition quality of life sleep non-pharmaceutical intervention

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Household Remedy

Group Type EXPERIMENTAL

Household Remedy

Intervention Type 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.

Tap Water

Group Type PLACEBO_COMPARATOR

Tap water

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Michigan

OTHER

Sponsor Role lead

Responsible Party

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Elliot B. Tapper

Assistant Professor of Internal Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Elliot Tapper, MD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

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University of Michigan

Ann Arbor, Michigan, United States

Site Status

Countries

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United States

Other Identifiers

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HUM00185598

Identifier Type: -

Identifier Source: org_study_id