Health Condition 1: G710- Muscular dystrophy
Conditions
Interventions
Intervention1: Prednisolone: prednisolone initial doses of 0.75 mg per kg per day with a maximum dose of 60 mg per day for initial 6 weeks duration, Following 6 weeks
if patient is receiving more tha
Sponsors
Dr P Sathish
Dr Rohit Bhatia
Eligibility
Inclusion criteria
Inclusion criteria: 1)Patients with immunohistochemical, immunoblot and genetically confirmed cases of calpainopathy LGMD2A, dysferlinopathy LGMD2B will be included in the trial. 2)Symptom onset less than 5 years 3)Medical Research Council (MRC) grade power of greater than or equal to 3/5 4)Able to stand on own, turn in bed, walk alone, eat and drink
Exclusion criteria
Exclusion criteria: 1)Obesity (BMI of 30 or above) 2)Diabetes Mellitus 3)Hypertension 4)Active infection on screening 5)Active TB 6)Retroviral illness 7)Any h/o melena, hematemesis, history of peptic ulcer disease 8)Chronic obstructive pulmonary disease (COPD). 9)Known cardiac failure and EF (ejection fraction) 10)Currently taking steroids for any other indication 11)Currently taking immunosuppressive therapy 12)Any immunosuppressive treatment till 2 months prior to screening period 13)Any condition in the understanding of investigator not ideal for usage of steroids 14)Pregnant and lactating mother 15)Patients on drugs that are known to improve muscle function such as CoQ, carnitine supplements etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1)Time taken to get up from supine to standing position from baseline to at the end of 6 weeks 2)Time taken to climb flight of four stairs from baseline to at the end of 6 weeks. 3)Amount of distance covered in 6 min walk test from the baseline to at the end of 6 weeks Timepoint: At the end of 6 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1)MRC Grade of selected muscle groups 2)Quality of life QOL assessment by SF-36 questionnaire 3)MR imaging of muscle to assess for inflammatory change Timepoint: At the end of 6 weeks | — |
Countries
India
Contacts
Public ContactDr Rohit Bhatia
All India Institute Of Medical Sciences(AIIMS) New Delhi
Outcome results
None listed