CirrhosisNCT04650295
Non-Pharmaceutical Intervention for Cirrhotic Cramps Reduction: The NICCles Trial
A study testing Household Remedy and Tap water in people with Cirrhosis and Muscle Cramp, run by University of Michigan at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cirrhosis, Muscle Cramp, Ascites
- What is being tested?
- Household Remedy and Tap water
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 82 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jan 2021to 2 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Household Remedy, Tap water
- Keywords
- Liver disease, Nutrition, quality of life, sleep, non-pharmaceutical intervention
- Medical subject headings
- Fibrosis, Muscle Cramp, Ascites, Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Household RemedyOther
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 waterOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Household Remedy | Experimental | Not described Receives: Other: Household Remedy |
| Tap Water | Placebo comparator | Not described Receives: Other: Tap water |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 28 days
Secondary outcomes (4)
Number of cramp-days per person
Measured: 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).
Measured: 28 days
Number of cramps during study
Measured: 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.
Measured: baseline, 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2020
- Study start18 Jan 2021
- Primary completion2 Dec 2021
- Study completion2 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CirrhosisStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elliot B. Tapper, University of Michigan
- Investigators
- Elliot Tapper, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04650295
- Sponsor's protocol ID
- HUM00185598
- Status last verified
- Dec 2021
- First submitted
- 24 Nov 2020
- Last updated
- 3 Dec 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Pharmaceutical Intervention for Cirrhotic Cramps Reduction: The NICCles Trial
- ClinicalTrials.gov ID
- NCT04650295
- Acronym / sponsor ID
- HUM00185598
- Conditions
- Cirrhosis, Muscle Cramp, Ascites
- Keywords
- Liver disease, Nutrition, quality of life, sleep, non-pharmaceutical intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 18 Jan 2021 (actual)
- Primary completion
- 2 Dec 2021 (actual)
- Study completion
- 2 Dec 2021 (actual)
- First posted
- 2 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Household Remedy | Experimental | Other: Household Remedy |
| Tap Water | Placebo comparator | Other: Tap water |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (6 listed)
- Non-English speaking
- Unable or unwilling to provide consent
- History of liver transplant
- History of multiple sclerosis
- History of cerebral palsy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Household RemedyIf 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 | Household Remedy |
| Tap waterIf 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. | Other | Tap Water |
Primary outcome
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).
4 secondary outcomes
Number of cramp-days per person
Time frame: 28 days
Number of days with cramp severity less than 5 on the Visual Analog Scale for Cramps
Time frame: 28 days
Number of cramps during study
Time frame: 28 days
Change in sleep quality based on the Pittsburgh Sleep Quality Index (PSQI)
Time frame: baseline, 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elliot Tapper, MD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Household Remedy and Tap water in people with Cirrhosis and Muscle Cramp, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in cramp severity after 28-days as measured by the Visual Analog Scale for Cramps (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2021.