Efficacy and Safety of Oral Prednisolone in Limb Girdle Muscular Dystrophy: A Randomized Double Blinded Placebo Controlled Trial

Dr P Sathish0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•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

•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.

发起方

Dr P Sathish