Health Condition 1: M625- Muscle wasting and atrophy, not elsewhere classified
Conditions
Interventions
Intervention1: The Role of Metformin and Melatonin in
Duchenne Muscular Dystrophy -A Randomized Control Trial
: It will be an outcome assesor blinded trial in which patients diagnosed with Duchenne mu
Sponsors
All India Institute of Medical Science Rishikesh
Eligibility
Inclusion criteria
Inclusion criteria: 1)Molecular / Biopsy based diagnosis of DMD 2)Patients 2 - 10 years of age at time of screening 3)Ambulatory patients
Exclusion criteria
Exclusion criteria: •History of glucocorticoids intake within the last 3 months •Use of Metformin or Melatonin within the last 3 months •Hypersensitivity to Metformin or melatonin •Suspected malignancy •Other chronic disease or clinical relevant limitation of renal, liver, heart function according to discretion of investigator •Participants not willing to give informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the change in Functional outcome by using Motor Function Measure (MFM) score after 3 months of Metformin, Melatonin and steroid (combined therapy) vs. steroid monotherapy alone.Timepoint: Three months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.To assess mean change in time taken to perform Gowerâ??s Maneuver (time taken in seconds to stand up from supine position) 2.Change in per minute walking distance 3.To assess change in Muscle weakness based on Medical Research Council (MRC) Scale 4.Change in 6 minute walking distance (6MWT) 5.To assess change in weight gain 6.To assess change in biochemical markers of DMD 7.To record the associated complications with both the therapies.Timepoint: Three months | — |
Countries
India
Contacts
Public ContactSunny Chaudhary
AIIMS Rishikesh
Outcome results
None listed