To asses the role of drug therapy in disease of muscle dysfunction of childre
Not Applicable
- Conditions
- Health Condition 1: M625- Muscle wasting and atrophy, not elsewhere classified
- Registration Number
- CTRI/2020/06/025541
- Lead Sponsor
- All India Institute of Medical Science Rishikesh
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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
•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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 1.To assess mean change in time taken to perform Gowerâ??s Maneuver (time taken in seconds to stand up from supine position) <br/ ><br>2.Change in per minute walking distance <br/ ><br>3.To assess change in Muscle weakness based on Medical Research Council (MRC) Scale <br/ ><br>4.Change in 6 minute walking distance (6MWT) <br/ ><br>5.To assess change in weight gain <br/ ><br>6.To assess change in biochemical markers of DMD <br/ ><br>7.To record the associated complications with both the therapies.Timepoint: Three months