Nocturnal Leg Cramps
Conditions
Interventions
Observation Group:None
Sponsors
The Third People's Hospital of Chengdu
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Signed informed consent form has been obtained; 2. Patients aged >18 years; 3. Male or female patients diagnosed with Nocturnal Leg Cramps (NLCs) according to reference diagnostic criteria; 4. The decision to initiate vitamin K2 treatment was made ??prior to and independent of?? study participation; 5. Patients ??must have received at least one dose?? of vitamin K2 for NLCs (i.e., completed initial administration).
Exclusion criteria
Exclusion criteria: 1. Treatment with vitamin K2 ??deviates from?? standard medical practice and/or the current spec sheet/label; 2. Participation in any other ??ongoing?? clinical trial (including but not limited to NLCs-related studies); ??3. Inability to provide?? baseline clinical data within 14 days ??preceding?? initial vitamin K2 treatment (including diagnostic evidence, risk factors, and episode frequency); ??4. Functionally incapable?? of self-recording and reporting muscle cramps; 5. Active severe psychiatric disorders; 6. Current use of ??warfarin?? at enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Symptom improvement rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Number and percentage of patients receiving each treatment regimen;Number and percentage of patients with treatment regimen transitions;Number and percentage of lost-to-follow-up cases at Weeks 2, 4, 6, and 8;Correlation between number of treatment sessions and symptom improvement rate;Total number of protocol-scheduled visits;Intervals between treatment sessions;Sleep Disturbance Improvement Rate; | — |
Countries
China
Contacts
Public ContactJing Tan
The Third People's Hospital of Chengdu, Chengdu, Sichuan, China
Outcome results
None listed