NCT04650295

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 82 (actual)
• Sponsor: University of Michigan · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cirrhosis
• Muscle Cramp
• Ascites

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2021-01-18
• Primary completion: 2021-12-02
• Completion: 2021-12-02
• First posted: 2020-12-02
• Last updated: 2021-12-03

Locations

1 site across 1 country: United States