A Clinical trial to study the efficacy and safety of prednisolone in limb girdle muscle dystrophy type 2A and 2B

Phase 3

Conditions: Health Condition 1: G710- Muscular dystrophy

Registration Number: CTRI/2021/02/031000

Lead Sponsor: Dr P Sathish

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

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

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) <35%

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1)Time taken to get up from supine to standing position from baseline to at the end of 6 weeks <br/ ><br>2)Time taken to climb flight of four stairs from baseline to at the end of 6 weeks. <br/ ><br>3)Amount of distance covered in 6 min walk test from the baseline to at the end of 6 weeks <br/ ><br>Timepoint: At the end of 6 weeks

Secondary Outcome Measures

Name	Time	Method
1)MRC Grade of selected muscle groups <br/ ><br>2)Quality of life QOL assessment by SF-36 questionnaire <br/ ><br>3)MR imaging of muscle to assess for inflammatory change <br/ ><br>Timepoint: At the end of 6 weeks