A clinical trial to compare the two ways of giving steroids (daily versus intermittent) in ambulatory patients with Duchenne Muscular Dystrophy

COMPARISON OF INTERMITTENT VERSUS DAILY REGIME OF PREDNISOLONE IN AMBULATORY PATIENTS WITH DUCHENNE MUSCULAR DYSTROPHY: AN OPEN LABEL RANDOMIZED CONTROLLED TRIAL

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2009/091/000738

Enrollment

Registered

2009-11-09

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Intemittent steroid therapy: Prednisolone 0.75 mg/kg/day OD 10 days a month for 6 months Control Intervention1: Daily Steroid therapy: Prednisolone 0.75 mg/kg/day OD daily for 6 months

Eligibility

Inclusion criteria

Inclusion criteria: All patients diagnosed as Duchenne muscular dystrophy, 5-10 years of age meeting the following criteria, will be included The European Neuromuscular Centre (ENMC) DMD diagnostic criteria (Emery 1997):Onset of proximal weakness by five years of age, 10-fold or greater elevation of serum CK, dystrophic muscle biopsy, absent or minimal dystrophin on muscle biopsy, and / or Duchenne-type mutation in the dystrophin gene.

Exclusion criteria

Exclusion criteria: Exclusion Criteria: 1. If they had used steroids for at least 7 days within 2 months before the start of the trial. 2. Non ambulatory 3. Unable to get up from floor without using external assistance. 4. Any contraindications to use of steroids (active infection, mantoux positive etc.)

Design outcomes

Primary

Measure	Time frame
Outcome Name: Muscle strength as measured by MMT score and isokinetic muscle testing.Timepoint: 6 months	—

Secondary

Measure	Time frame
1. Timed functional capacities at 3 and 6 months 2. Musclular Dystrophy Specific functional rating scale 3 and 6 months 3. Pulmonary function as measured by spirometry 6 months 4. Side effects like weight gain, hypertension, excessive hair groth, cushingoid facies, infection, cataract. 3 and 6 months Timepoint: 3 and 6 months	—

Countries

India

Contacts

Public ContactSheffali Gulati

sheffaligulati@gmail.com09868397532

Outcome results