An observational study of Vitamin K2-7 (MK-7) in patients with Muscle Cramps
- Conditions
- Health Condition 1: M638- Disorders of muscle in diseases classified elsewhereHealth Condition 2: null- Idiopathic muscle cramps
- Registration Number
- CTRI/2013/09/003998
- Lead Sponsor
- Viridis BioPharma Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 20
1. Men & women with idiopathic muscle cramps (cramp will be defined as a painful contraction of any muscle group in the leg, which was either precipitated by certain movements, aborted by
procedures involving stretch of the affected muscle or which was associated with a palpable
hardening of the muscle. To qualify for trial inclusion, subjects should have a stable pattern of two or more cramps per week for three months.
2. Willing to participate in the trial
1. Subjects with physiological conditions causing cramps like pregnancy or during sports activity
2. Patients with severe neurological, muscular, psychiatric, endocrinological, metabolic medical
conditions or vascular diseases, electrolyte imbalance, liver cirrhosis causing muscle cramps will be excluded
3. Subjects on drugs which are likely to affect muscle cramps
4. Subjects with any known hypersensitivity to Vitamin K
5. Patients with any cancers receiving chemotherapy/ radiation
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The difference in number, duration and severity of cramps after treatment as compared to baselineTimepoint: 4 months
- Secondary Outcome Measures
Name Time Method 1.The subjectâ??s assessment of whether treatment was effective and any other change noticed in health <br/ ><br>while on treatment <br/ ><br>2.To assess any carry-over effect of the treatmentTimepoint: 4 months