A clinical trial to compare the two ways of giving steroids (daily versus intermittent) in ambulatory patients with Duchenne Muscular Dystrophy
Phase 4
- Registration Number
- CTRI/2009/091/000738
- Lead Sponsor
- one
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 60
Inclusion Criteria
All patients diagnosed as Duchenne muscular dystrophy, 5-10 years of age meeting the following criteria, will be included
The European Neuromuscular Centre (ENMC) DMD diagnostic criteria (Emery 1997):Onset of proximal weakness by five years of age, 10-fold or greater elevation of serum CK, dystrophic muscle biopsy, absent or minimal dystrophin on muscle biopsy, and / or Duchenne-type mutation in the dystrophin gene.
Exclusion Criteria
Exclusion Criteria:
1. If they had used steroids for at least 7 days within 2 months before the start of the trial.
2. Non ambulatory
3. Unable to get up from floor without using external assistance.
4. Any contraindications to use of steroids (active infection, mantoux positive etc.)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method