CTRI/2026/04/107251 [Registered on: 01/04/2026] Trial Registered Prospectively
Last Modified On:
28/03/2026
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Drug
Study Design
Single Arm Study
Public Title of Study
A study to see if beta-glucan is safe and helps improve movement in children with Duchenne muscular dystrophy (DMD).
Scientific Title of Study
Evaluation of the efficacy and safety of beta glucan in children with Duchenne Muscular Dystrophy in terms of decreasing inflammatory biomarkers and improving functional mobility
Trial Acronym
nil
Secondary IDs if Any
Secondary ID
Identifier
NIL
NIL
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Suvarna Magar
Designation
Associate Professor
Affiliation
MGM Medical College
Address
Pediatric Department, MGM Medical College, N-6, CIDCO, Chh Sambhaji Nagar, Aurangabad Pediatric Department, MGM Medical College, N-6, CIDCO, Chh Sambhaji Nagar, Aurangabad Aurangabad MAHARASHTRA 431002 India
Phone
9004045137
Fax
Email
drsuvarnamagar@gmail.com
Details of Contact Person Scientific Query
Name
Dr Suvarna Magar
Designation
Associate Professor
Affiliation
MGM Medical College
Address
Pediatric Department, MGM Medical College, N-6, CIDCO, Chh Sambhaji Nagar, Aurangabad Pediatric Department, MGM Medical College, N-6, CIDCO, Chh Sambhaji Nagar, Aurangabad Aurangabad MAHARASHTRA 431002 India
Phone
9004045137
Fax
Email
drsuvarnamagar@gmail.com
Details of Contact Person Public Query
Name
Dr Suvarna Magar
Designation
Associate Professor
Affiliation
MGM Medical College
Address
Pediatric Department, MGM Medical College, N-6, CIDCO, Chh Sambhaji Nagar, Aurangabad Pediatric Department, MGM Medical College, N-6, CIDCO, Chh Sambhaji Nagar, Aurangabad Aurangabad MAHARASHTRA 431002 India
Phone
9004045137
Fax
Email
drsuvarnamagar@gmail.com
Source of Monetary or Material Support
Health ‘N’ U Therapeutics Pvt. Ltd.
709, 7th Floor, Palm Spring Center,
Link Road, Malad West,
Mumbai- 400064.India
Primary Sponsor
Name
Health N U Therapeutics Pvt Ltd
Address
Health ‘N’ U Therapeutics Pvt. Ltd.
709, 7th Floor, Palm Spring Center,
Link Road, Malad West,
Mumbai, 400064.
(1) ICD-10 Condition: G328||Other specified degenerative disorders of nervous system in diseases classified elsewhere,
Intervention / Comparator Agent
Type
Name
Details
Intervention
1 3 1 6 beta glucan therapy
1 3 1 6 beta glucan will be tested for efficacy and safety in children with DMD for reduction of inflammatory biomarkers like CPK Interleukin 6 and tumor necrosis factor alfa and improvement in mobility. The drug will be given for 6 months duration
Comparator Agent
Not applicable
Not applicable
Inclusion Criteria
Age From
3.00 Year(s)
Age To
15.00 Year(s)
Gender
Both
Details
Subject willing to and able to comply with protocol
ExclusionCriteria
Details
1) Patients with a previous (within past 1 month) or concomitant participation in any other therapeutic trial
2) Subjects and legally authorized representative for vulnerable subjects who has not given informed consent
3) Subjects with history of other muscular atrophy disorder
4) Subjects with known or suspected malignancy, any other chronic disease or clinically relevant limitation of renal, liver or heart function according to the discretion of the investigator
Method of Generating Random Sequence
Not Applicable
Method of Concealment
Not Applicable
Blinding/Masking
Not Applicable
Primary Outcome
Outcome
TimePoints
Reduction in inflammatory markers
baseline, 3 months, 6 months
Secondary Outcome
Outcome
TimePoints
Change in MRC and NSAA score from baseline at 3 and 6 month
3 and 6 months
Target Sample Size
Total Sample Size="25" Sample Size from India="25" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
Phase of Trial
Phase 4
Date of First Enrollment (India)
09/04/2027
Date of Study Completion (India)
Applicable only for Completed/Terminated trials
Date of First Enrollment (Global)
Date Missing
Date of Study Completion (Global)
Applicable only for Completed/Terminated trials
Estimated Duration of Trial
Years="0" Months="6" Days="0"
Recruitment Status of Trial (Global)
Not Yet Recruiting
Recruitment Status of Trial (India)
Not Yet Recruiting
Publication Details
N/A
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
What data in particular will be shared? Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
What additional supporting information will be shared? Response - Study Protocol Response - Statistical Analysis Plan Response - Clinical Study Report
Who will be able to view these files? Response - Anyone
For what types of analyses will this data be available? Response - To achieve aims in the approved proposal.
By what mechanism will data be made available? Response (Others) - De-identified data will be available in the publication
For how long will this data be available start date provided 20-03-2026 and end date provided 04-03-2027? Response - Immediately following publication. No end date.
Any URL or additional information regarding plan/policy for sharing IPD? Additional Information - NIL
Brief Summary
Duchenne muscular dystrophy DMD is a rare genetic disease causing muscle degeneration due to lack of dystrophin with inadequate muscle regeneration culminating in muscle dysfunction
The goal of treatment approaches to muscular dystrophies including limb girdle muscular dystrophy, has been to focus on improving the quality of life of patients while maintaining mobility and functional independence for as long as possible apart from effectively managing the comorbidities. The complexity of the disease makes the challenges enormous.
The beneficial effects of a 1 3 1 6 beta-glucan from the N 163 strain of the black yeast Aureobasidium pullulans BGCAN in decreasing inflammatory biomarkers such as interleukin 6 and tumor growth factor and interleukin 13 and increased dystrophin levels as well as improved muscle strength in patients with DMD in a clinical study conducted in 28 patients for a 45-day period and then the muscle improvement in a study of 6 months.
The N 163 strain of Aureobasidium pullulans produced beta 1 3 1 6 glucan reported to be safe with anti inflammatory and anti fibrotic efficacy So we wanted to detect the reduction in inflammatory markers and functional mobility score in patients with DMD after enrolling in the trial