Health Condition 1: M625- Muscle wasting and atrophy, not elsewhere classified
Conditions
Interventions
None listed
Sponsors
ALL INDIA INSTITUTE OF AYURVEDA
Eligibility
Inclusion criteria
Inclusion criteria: Male patients aged 5 to 12 years already diagnosed with Duchenne muscular dystrophy weight atleast 20 kg at screening Ambulant patients able to walk at least 50 meters without assistance North Star Ambulatory Assessment NSAA total score atleast 40 percent of maximum Stable cardiac and respiratory functions Ability to comply with study procedures as determined by the investigator Patients taking steroids would be taken after a washout period of 30 days Written informed consent from parents OR legal guardians and assent from the child when appropriate
Exclusion criteria
Exclusion criteria: Allergy or hypersensitivity to any components used in Panchakarma therapy including medicated oils and herbal preparations Concurrent participation in any other interventional clinical trial or participation within 3 months prior to screening 3. Planned or expected spinal fusion surgery during the study period or previous spinal fusion surgery within the last 6 months Prior gene therapy or cell based therapy for DMD Any medical condition that in the investigators opinion might compromise patient safety or study results
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the efficacy of Kushmand Rasayana and Panchkarma therapies in managing ambulatory boys with DMD aged 5 to 12 years over a period of 2 months as measured by NSAA scaleTimepoint: 0,30,60,90 day | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess improvement in Peds3 Quality of Life Scale Timepoint: 0,30,60,90 day;To assess changes in inflammatory markers and muscle enzyme levels Timepoint: 0,60,90 day;To assess changes in respiratory functions using spirometry Timepoint: 0,60,90 day | — |
Countries
India
Contacts
Public ContactDr Harshit Jain
ALL INDIA INSTITUTE OF AYURVEDA
Outcome results
None listed