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To Compare and Evaluate the Effect of Duchenne Muscular Dystrophy affected Patients Undergoing Current Treatment Along with Food Supplements

An Open Label, Prospective, Randomized, Comparative, Multiple Arm Clinical Study to Evaluate the Immunomodulatory Efficacy of Nichi Glucan in Comparison with Conventional Therapeutic Regimen in patients with Duchenne Muscular Dystrophy (DMD)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/05/033346
Enrollment
24
Registered
2021-05-04
Start date
Unknown
Completion date
Unknown
Last updated
2023-04-03

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

Conditions

Health Condition 1: M638- Disorders of muscle in diseases classified elsewhere

Interventions

Intervention1: AFO-202: 1g of AFO-202 Beta Glucan daily (1 g sachet with any one meal) Intervention2: AFO-202 and N-163: 1g of AFO-202 Beta Glucan daily (1 g sachet with any one meal) 1 sachet of N-

Sponsors

NichiIn Biosciences Pvt Ltd
Lead Sponsor
GN Corporation Co Ltd
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: 1. Subject who diagnosed with DMD 2. Aged from 6-18 3. Patients who are to participate in the study with a written inform consent form.

Exclusion criteria

Exclusion criteria: Subjects who are not a part of any clinical studies prior to 30 days.

Design outcomes

Primary

MeasureTime frame
Observation of changes in the levels of IL-6 and Myoglobin urea from the baseline.Timepoint: Day 45±1

Secondary

MeasureTime frame
1. Measurement of the levels of CK, Titin, TNF, Haptoglobin, Dystrophin level, LFT,CBC,Cystatin C 2. Immunological Parameters: IL-13,CD-40,ESR Timepoint: Day 1, Day21 ± 1, Day 45±1 and Monitoring Adverse events each visits

Countries

India

Contacts

Public ContactDr S R Tiruvalavan

Kenmax Medical Service Private Limited

drkraghavan27@gmail.com9840301991

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 10, 2026