Health Condition 1: M638- Disorders of muscle in diseases classified elsewhere
Conditions
Interventions
Intervention1: Standard of Care with β-1, 3-1, 6-Glucan, N-163
: this is a produce of N-163 strain
of Black Yeast Aureobasidium
Pullulans. the N-163 strain
produce has been proven to
have potent ant
Sponsors
MediNippon Health Care Private Limited MDN
NichiIn Bio Sciences Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subject who diagnosed with another muscular dystrophy other than Duchenne Muscular Dystrophy (DMD) 2. Male and Female subjects of age in between 3 years to 70 years 3. Subjects and legally authorized representative for vulnerable subjects must be willing to participate in the study and provide a written informed consent 4. Subject willing to and able to comply with the protocol
Exclusion criteria
Exclusion criteria: 1. Subject participated in another clinical trial in the last 30 days. 2. Subjects and legally authorized representative for vulnerable subjects who has not given informed consent for this study 3. Subjects with history of multiple sclerosis 4. Subjects with history of any muscular atrophy 5. Pregnant and lactating females
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Observation of changes in the levels of IL-6 and Myoglobin urea from the baseline.Timepoint: Day 180±3 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Measurement of the levels of CK, Titin, TNF, Haptoglobin, Dystrophin level, LFT, CBC, Cystatin C 2. Immunological Parameters: IL-13, CD-40, ESRTimepoint: Day 30±3, Day 60±3, Day 90±3, Day 120±3, Day 180±3 and Monitoring Adverse events each visits | — |
Countries
India
Contacts
Public ContactDr S R Tiruvalavan
Jaicare Hospital
Outcome results
None listed